Multiple Mental Health ConditionsCALMNCT07699159
Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions
An observational study of Multiple Mental Health Conditions and Child Mental Health, run by Centre for Addiction and Mental Health at 6 sites in Canada.
Trial summary
The Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM) Master Observational Trial is a prospective, longitudinal observational study that seeks to improve clinical care for youth with multiple mental health conditions (MMHC), also known as mental health multimorbidity in the… Read more about this study
- Who is it for?
- Ages 11 to 24 years
- Conditions the study is for
- Multiple Mental Health Conditions, Child Mental Health, Youth Mental Health
- How many people
- 1,620 participants
- Where
- 6 sitesCanada
- Study dates
- 4 Mar 2025to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The CALM network will recruit children and youth aged 11-24 who have sought, are seeking, or are accessing mental health care from 5 partner sites in Ontario (Centre for Addiction and Mental Health, Hospital for Sick Children, McMaster Children's Hospital, Children's Hospital of Eastern Ontario, and The Royal Ottawa Mental Health Centre) and 1 partner site in Alberta (Alberta Health Services) as well as the broader community. Caregivers of CALM participants will be asked to complete caregiver specific questionnaires (self-report and completing the measures based on their child/youth). When a CALM child/youth participant is approached for the study, we will ask said participant if we can contact their caregiver to participate in the study. We will then approach the caregiver for consent. No external recruitment of non-CALM participants caregivers will be implemented.
Who may be able to join
- The participant must meet all of the inclusion criteria to be eligible for this research study:
- Light Phenotype Eligibility Must sign and date the informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent; Aged 11-24 years old at the time of screening; Any person within age criteria who has previously sought, is seeking, or is accessing mental health services; Are able to complete assessments in English.
- Deep Phenotype Eligibility Must be part of the CALM light phenotype cohort; Must sign and date the deep phenotyping informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent.
- Light Phenotype Caregiver Participant Eligibility:
- Any caregiver of a CALM child/youth participant is eligible to participate in the study, insofar as the child/youth participant has consented to the light phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.
- Deep Phenotype Caregiver Participant Eligibility:
- Any caregiver of a CALM child/youth participant is eligible to participate in the study, insofar as the child/youth participant has consented to the deep phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this research study:
- Light Phenotype Does not provide informed consent (for those with the capacity to consent) or assent (for those who lack the capacity to consent); For those individuals who lack the capacity to consent, the inability of the parent/legal guardian to provide informed consent for the youth is also an exclusion criterion; Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.
- Deep Phenotype Unable to participate in deep phenotyping protocol (e.g., MRI contraindication, uncorrected vision or hearing impairments that would interfere with data collection, unwillingness to complete assessments); No exclusion criteria are based on race, ethnicity, sex or gender.
- Light Phenotype Caregiver Participant Ineligibility:
- Caregivers of CALM child/youth participants are ineligible to participate in the study if:
- The child/youth participant does not agree for their caregiver to be contacted to participate in the study; The child/youth participant is not participating in the light phenotype cohort; Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.
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- Deep Phenotype Caregiver Participant Ineligibility:
- Caregivers of CALM child/youth participants are ineligible to participate in the study if:
- The child/youth participant does not agree for their caregiver to be contacted to participate in the study; The child/youth participant is not participating in the deep phenotype cohort (i.e., is only participating in the light phenotyping cohort); Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Paul Arnold, MD, PhD, FRCPC, 403-210-6464, paul.arnold@ucalgary.ca
Sadanee Pathiranawasam, MSc, 647-515-6560, sadanee.pathiranawas@ucalgary.ca
- Recruiting
McMaster Children's Hospital, Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Melissa Kimber, BA, BSW, MSW, PhD, 905-525-9140 ext. 27220, kimberms@mcmaster.ca
Alexe Bernier, PhD, 403-542-5610, bernia1@mcmaster.ca
- Recruiting
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Ontario, K1H 8L1
Gary Goldfield, PhD, C. Psych., 613-737-7600 ext. 2721, ggoldfield@cheo.on.ca
Karina Branje, 613-737-7600 ext. 4899, kbranje@cheo.on.ca
- Recruiting
The Royal Ottawa Mental Health Centre
Ottawa, Ontario, K1Z 7K4
Jennifer Phillips, PhD, 613-722-6521 ext. 6971, jphillips@theroyal.ca
Aster Javier, MSc, 613-722-6521 ext. 6437, ajavier@theroyal.ca
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Suneeta Monga, MD, FRCPC, 416-813-7531, suneeta.monga@sickkids.ca
Atushi Patel, 437-212-3207, atushi.patel@sickkids.ca
- Recruiting
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J1H4
Louise Gallagher, MD, PhD, 416-535-8501 ext. 33566, louise.gallagher@camh.ca
Janani Selvachandran, PhD, 437-441-2294, janani.selvachandran@camh.ca
About this study
Official title: Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM): A Master Observational Trial
The Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM) Master Observational Trial is a prospective, longitudinal observational study that seeks to improve clinical care for youth with multiple mental health conditions (MMHC), also known as mental health multimorbidity in the literature. MMHC is conceptualized as the presence of two or more mental health diagnoses under the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). MMHC is common in youth seeking mental health services and is associated with less favorable outcomes and greater health services utilization. Mental health disorders also accumulate in youth over time. The Master Observational Trial (MOT) will investigate MMHC in critical developmental periods in youth and identify risk and protective factors that will provide a mechanistic understanding of how MMHC develops over time. A subset of participants will also enroll in a Deep Phenotyping Cohort, which includes enhanced clinical and cognitive assessments and multimodal neuroimaging to investigate neurobiological mechanisms underlying MMHC and identify potential biomarkers of illness complexity and progression.
In the near future, we aim to add to the current protocol to embed both a clinical trials network for youth mental health in Ontario and Calgary within the CALM study and add digital phenotyping using wearable technology to generate digital and physiological markers of MMHC. The current protocol focuses on establishing the longitudinal MOT cohort and Deep Phenotype Cohort only as a first step towards these long term CALM goals.
Read the detailed description
The primary objectives of the CALM MOT are to:
- Establish a prospective, longitudinal cohort of children and youth aged 11-24 years to characterize the progression and outcomes of MMHC over time.
- Facilitate later development of a clinical trials network and clinical research in MMHC with a focus on developing transdiagnostic interventions and improving care.
- Establish a deeply phenotyped cohort of youth in a subset of participants enrolled in the MOT (light phenotyping protocol), using multidimensional, multilevel data to investigate brain-based mechanisms of MMHC with potential for biomarker discovery.
Specific objectives of the Deep Phenotyping Cohort are to:
- Collect data across CALM sites in participants that are eligible and consent to participate in CALM MOT Light and the Deep Phenotyping Protocol. In this subset of CALM participants, we will extend the clinical/behavioural measurement battery, and collect high quality cognitive and multimodal (T1, multi-shell DWI, resting state, ASL) neuroimaging data that will be undertaken as part of the CALM baseline deep phenotyping protocol.
- Use open access brain age and centile score calculators using unimodal brain imaging data to examine centile score distributions for various data samples in a sex stratified manner (e.g., clinical/community ascertained) and associations between centile scores with behavioral/cognitive indices of clinical severity/impairment and MMHC (e.g., MMHC index). Available open access normative and clinically enriched neuroimaging samples that overlap with the proposed CALM sample age range (11-24 years) will be utilized.
- Undertake analysis using cross-sectional neuroimaging and longitudinal MOT data derived from the CALM network to test whether deviations from normative brain measures using either unimodal or integrating data from different imaging sequences (i.e., multimodal), imaging calculators may have utility as a baseline 'prognostic/predictive' marker of youth who may have more complex illness (i.e., MMHC) at the time of initial (baseline) participation in the CALM study and at subsequent time points and/or may be less responsive to clinical interventions.
- Keywords
- multiple mental health conditions, child and youth mental health, mental health multimorbidity, master observational trial, deep phenotyping cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MOT | In the MOT/Light Protocol, clinical, and functional measures will be collected in addition to blood-based 'omics' including proteomic (immune markers) and genomic analysis of DNA derived from blood and/or saliva. Over 3 years n=1620 children and youth will be recruited to the MOT/Light Protocol across the CALM Network. A number of measures will be collected throughout the course of the study in order to capture symptoms across a spectrum of conditions in the target population. Provided that the main objective of the CALM project is to improve clinical care for youth with a particular focus on MMHC, it is vital to use validated standardized assessments that test highly prevalent physical and mental health conditions. MOT/Light measures will be collected via self-report (SR), rated-administered (RA), caregiver-administered (Ca), or a combination | |
| Deep Phenotyping | Multidimensional, multilevel data will be obtained in a subcohort of CALM Study youth (3 years n=~614) recruited to the MOT who also consent to participate in the Deep Phenotyping protocol. The Deep Phenotyping Protocol includes additional clinical, behavioural, developmental and functional outcomes, not collected as part of the light phenotyping battery as well as the collection of neurocognitive measures and neuroimaging data. Cognitive phenotyping will be administered at 0 and 6 month time points. Neuroimaging will be collected at one time point, harmonized across sites using human connectome quality scanning and to key external initiatives (e.g., neuroimaging via ABCD) facilitating secondary data use, and the utilization of additional cohorts in analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Assessment for the Health Spectrum
The Diagnostic Assessment for the Health Spectrum (DASH) is a semi-structured screener and interview that evaluates a broad range of psychiatric symptoms and associated symptoms. It also assesses a number of physical health symptoms. The DASH is based on the core structure of the Schedule for Affective Disorders and Schizophrenia-SADS and Kiddie-SADS, and includes features of a number of other structured interviews of psychopathology. It provides a diagnostic spectrum in addition to categorical diagnoses that are aligned to the DSM-IV and DSM-5. The completed interview yields a narrative report and summary for clinicians and researchers. There are three versions (adult, child, and parent on child) which take approximately 90-240+ minutes to complete.
Measured: Baseline and 24 months
Adolescent Health History
Youth and caregivers will be asked to self-report the presence of health conditions using the Adolescent Health History measure to indicate whether the youth has in the past or currently has any of over 40 common mental or physical health conditions listed. Youth will also be able to add up to four other conditions not listed.
Measured: Baseline, 12 months, 24 months
Assessment of Quality of Life
The Assessment of Quality of Life (AQoL) measures 5 dimensions: illness, independent living, social relationships, physical senses and psychological well being. Each dimension is measured by three items (a total of 15 items).
Total scores can range from a minimum of 20 to a maximum of 99, with higher scores indicating poorer quality of life.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Brain-CODE Demographic Form
The Brain-CODE Demographic Form is a standard form developed by Brain-CODE to capture demographic information from participants.
Measured: Baseline, 12 months, 24 months
Brain-CODE Medical History Form incorporating Developmental History Questionnaire (DHQ) Items
The Brain-CODE Medical History Form is a standard form developed by Brain-CODE to capture medical history in participants.
Measured: Baseline, 12 months, 24 months
Canadian Health Survey on Children and Youth (CHSCY) Childhood Experiences Scale
The Canadian Health Survey on Children and Youth (CHSCY) Childhood Experiences Scale includes 10 items assessing youth's self-reported exposure to different forms of maltreatment by their caregivers, including physical, sexual and emotional abuse, neglect, as well as exposure to violence between caregivers. One additional item captures youth's exposure to corporal punishment. Items have been administered in population-based studies that include samples of youth and adults, as well as clinical observational studies and trials. Total scores can range from a minimum of 10 to a maximum of 50, with higher scores indicating more negative experiences.
Measured: Baseline, 12 months, 24 months
Child and Youth Resilience Measure
The Child and Youth Resilience Measure is a screening tool to explore the resources (individual, relational, communal and cultural) available to individuals that may bolster their resilience. Individuals aged 24+ will be asked to complete the Adult Resilience Measure. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Measured: Baseline, 12 months, 24 months, 36 months
The Columbia Suicide Severity Rating Scale
The Columbia Suicide Severity Rating Scale is a validated and widely used rater-administered measure of suicidal ideation and behaviour, and non-suicidal self-injury. It will be administered to all participants. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Measured: Baseline, 24 months
Self-Injurious Thoughts and Behaviours Interview
The Self-Injurious Thoughts and Behaviours Interview (SITBI) measures self-injurious thoughts and behaviors.
Measured: Baseline, 24 months
Canadian Health Survey on Children and Youth (CHSCY) Bullying Scale
The Canadian Health Survey on Children and Youth (CHSCY) Bullying Scale includes 10 items and is designed to assess youth exposure to bullying in the preceding 12 months. Items capture both the type and frequency of bullying, with types of bullying covered by the measure including verbal, physical, relational, and online forms of bullying. Response options are captured on an ordinal scale encompassing: Never, A few Times a Year, Monthly, Weekly, Daily. Total scores can range from a minimum of 10 to a maximum of 50, with higher scores indicating more experiences with bullying.
Measured: Baseline, 12 months, 24 months
Difficulties in Emotion Regulation Scale Short Form
The Difficulties in Emotion Regulation Scale Short Form is an 18-item measure used to identify emotional regulation issues. The measure covers 4 dimensions of emotional regulation: awareness and understanding of emotions; acceptance of emotions; the ability to engage in goal-directed behavior and refrain from impulsive behavior when experiencing negative emotions; and access to emotion regulation strategies perceived as effective. Total scores can range from a minimum of 18 to a maximum of 90, with higher scores indicating more difficulties with emotion regulation.
Measured: Baseline, 12 months, 24 months, 36 months
Eating Disorder Examination Questionnaire (EDE-QS) Short Form
The Eating Disorder Examination Questionnaire (EDE-QS) Short Form is a 12-item, self-report questionnaire capturing eating disorder symptoms. Response options are anchored on a 4-point ordinal response scale that captures symptoms over the preceding 7 days. Total scores can range from a minimum of 0 to a maximum of 36, with higher scores indicating the presence of more eating disorder symptoms.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
General Anxiety Disorder-7
The General Anxiety Disorder-7 (GAD-7) measures presence and severity of Generalized Anxiety Disorder. Total scores can range from a minimum of 0 to a maximum of 21, with higher scores indicating greater presence and severity of anxiety symptoms.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
General Behaviour Inventory-10 Mania
The General Behaviour Inventory-10 Mania measures the presence and severity of mania. Total scores can range from a minimum of 0 to a maximum of 30, with higher scores indicating greater presence and severity of mania.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
General Life Satisfaction
A singular question from the Canadian Social Survey - Quality of Life and Energy Consumption Behaviours measure will be administered to determine life satisfaction. Total scores can range from a minimum of 0 to a maximum of 10, with higher scores indicating greater life satisfaction.
Measured: Baseline, 18 months, 30 months
The Goal-Based Outcome (GBO) Tool
The Goal-Based Outcome (GBO) Tool aims to measure the progress and outcomes of an intervention in a simple way. It can be applied in any setting and is currently available in 9 languages. The child GBO tool contains a record sheet whereby up to 3 goals with their descriptions can be written down, followed by a goal rating sheet with descriptions and a scale ranging from 0 (Goals not at all met) to 10 (Goal reached). A goal progress chart at the end can be used to rate the progress of the goal across 12 sessions.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Internalized Stigma of Mental Illness
The Internalized Stigma of Mental Illness (ISMI) scale is a questionnaire measuring self-stigma among persons with psychiatric disorders. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Measured: Baseline
International Sedentary Assessment Tool
This measure consists of two parts. The first part has six items, and asks questions based on typical weekday activity in the last week. The second part also includes six items and asks questions pertaining to typical weekend activities within the last week. Higher scores equate to more sedentary behaviors in a participant.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
McMaster Family Functioning Scale
The McMaster Family Functioning Scale is a shorter 12-item assessment developed from The McMaster Family Assessment Device, which is a 60-item questionnaire that measures an individual's perceptions of their family. Total scores can range from a minimum of 12 to a maximum of 48, with higher scores indicating more positive perceptions of family.
Measured: Baseline, 12 months, 24 months, 36 months
Treatment Log
This inventory records prescribed treatment and medication, adherence and tolerability every 6 months.
Measured: Baseline, 6 months, 18 months, 24 months, 30 months, 36 months, 42 months
Ohio State University Traumatic Brain Injury Identification Method
The Ohio State University Traumatic Brain Injury Identification Method measures a participant's history of traumatic brain injury. Baseline and follow-up versions will be administered.
Measured: 3 months, 30 months
Ontario Child Health Study Emotional Behavioural Scales - Brief
The Ontario Child Health Study Emotional Behavioural Scales - Brief (OCHS-EBS-B) is a 25-item measurement tool for participants under the age of 18 that assesses common child/youth mental health disorders within the last 6 months. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Measured: Baseline, 6 months, 24 months
Patient Global Improvement Scale
The Patient Global Improvement Scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Scores range from 0 to 7, with lower scores reflecting more positive symptoms and thus improvement in clinical status.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Patient Health Questionnaire
The Patient Health Questionnaire (PHQ) is a self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day).
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Pittsburgh Sleep Quality Index
This assessment is designed to evaluate the overall sleep quality in a clinical population. It is a 19-item self-reported questionnaire assessing seven subcategories; use of sleeping medication, subjective sleep quality, sleep latency, duration, sleep efficiency, disturbances and dysfunction during the daytime. Each subcategory ranges from scores of 0 to 3, with higher scores reflecting poorer sleep patterns.
Measured: Baseline
Phlebotomy (blood) collection
Blood will be collected by a trained phlebotomist or research nurse with experience working with children and youth. Blood will be collected at baseline, and then annually. A maximum of 40 mL of blood will be collected per participant; however, sites may collect reduced volumes due to site-specific procedures and/or participant limitations. To ensure sufficient sample volumes for clinical and genetic/immune analyses, a minimum collection threshold will be applied to each.
Clinical testing (7-20 mL): Samples will be transferred to clinical labs for CBC, differential white cell count, HbA1C, CRP, glucose, and lipid testing.
Genetic and immune analysis (16-20 mL): Samples will be analyzed for genetic, epigenetic, and immune markers.
Sites will aim to collect the full 20 mL for both clinical and genetic testing whenever possible.
Measured: Baseline, 12 months, 24 months
Physical Exam (Height, Weight, Body Mass Index, Waist Circumference, Neck Circumference, and Blood Pressure)
A physical exam will be completed by trained research or clinical staff during the clinic visit. If the participant is unable to attend the clinic visit, research staff will use recent values from their medical record or provide instructions to the participant for measuring their height, weight, waist circumference and neck circumference at home (blood pressure will not be measured at home).
Measured: Baseline, 12 months, 24 months, 36 months
PRIME- Revised
This is a self-administered questionnaire that is designed to assess individuals at risk for developing a psychotic disorder. It contains 12 items that assess positive symptoms on a distress scale ranging from 0 (Definitely disagree) to 6 (Definitely agree).
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 42 months
Revised Child Anxiety and Depression Scale
The Revised Child Anxiety and Depression Scale (RCADS-25) is a self-report questionnaire that assesses symptoms of depression and anxiety in children and adolescents. This assessment captures symptoms related to generalized anxiety disorder (GAD), major depressive disorder (MDD), panic disorder, social phobia, separation anxiety disorder (SAD), and obsessive-compulsive disorder (OCD).
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Saliva collection
Participants will be asked to provide a saliva sample to be used for genetic and epigenetic analyses. A saliva collection kit, such as that made by Oragene, will be used. Approximately 1.5 mL of saliva is provided when someone 'spits' into the collection tube. Cheek cells in saliva contain the DNA that will ultimately be extracted and processed.
Measured: Baseline, 12 months, 24 months
The Short Warwick-Edinburgh Mental Well-being Scale
The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) uses seven statements about thoughts and feelings to monitor mental wellbeing. The seven statements are positively worded with five response categories from 'none of the time' to 'all of the time'. Children and young people are asked to describe their experiences over the past two weeks.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Social Communication Questionnaire
The Social Communication Questionnaire (40-item parent questionnaire), which is based on the Autism Diagnostic Interview-Revised, will be used to measure current and developmental social communication deficits. This parent-report questionnaire provides information regarding social communication and repetitive behaviours present currently and from early childhood. Total scores can range from a minimum of 0 to a maximum of 39, with higher scores indicating stronger social communication.
Measured: Baseline
Social Responsiveness Scale (SRS) - Short Form
The Social Responsiveness Scale measures the severity of autism symptoms in a quantitative manner, both among children affected by symptoms that fall under the spectrum of autism as well as among children in the general population. Caregivers will complete the caregiver report school short form. Total scores can range from a minimum of 16 to a maximum of 64, with higher scores indicating lower social responsiveness.
Measured: Baseline, 12 months, 24 months, 30 months, 42 months
Strengths and Weaknesses of Attention-Deficit/Hyperactivity (SWAN) Disorder Symptoms and Normal Behavior scale
The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior scale assesses ADHD symptoms in the clinical and non-clinical population. It includes a set of 18 questions and a child's behavior is scored on a 7-point scale with 4 (average) reflecting a normal behavior for the child's age. The first 9 items are associated with inattentive ADHD and the next 9 items are associated with hyperactive/impulsive ADHD.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Suicidal Ideation Questionnaire-Junior
The Suicidal Ideation Questionnaire-Junior (SIQ-JR) consists of 15 items and will be completed by all youth in this study. It is designed for students in Grades 7-9. This assessment assists in informing adults/professionals of their levels of distress and suicidal intent without self-injurious behaviour. The overall aim of this measure is to assess suicidal ideation and risk.
Measured: Baseline, 3 months, 12 months, 24 months, 30 months, 42 months
Toronto Obsessive-Compulsive Scale - Brief
The Toronto Obsessive-Compulsive Scale (TOCS) is a 21-item parent or self-report questionnaire that assesses symptoms pertaining to Obsessive-Compulsive traits among children or adolescents. Total scores can range from a minimum of -72 to a maximum of 72, with higher scores indicating the presence of more Obsessive-Compulsive traits.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Unmet Needs Questionnaire
The Unmet Needs Questionnaire measures the services participants are receiving and whether their needs are being met.
Measured: 12 months, 24 months, 36 months
Youth Life Interference Scale
The Youth Life Interference Scale (YLIS) is an 11-item self-report measure assessing the impact of mental health symptoms on day-to-day functioning in the past two weeks. The measure was developed in-house for the TAY study. Its focus lies on functional impairment related to anxiety and depression for youth. Total scores can range from a minimum of 0 to a maximum of 36, with higher scores indicating greater functional impairment.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Kiddie Schedule for Affective Disorders and Schizophrenia
The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a widely used structured diagnostic interview that will be administered to participants in order to determine the presence of categorical mental health diagnoses. The K-SADS will be used for participants less than 18 years of age.
Measured: Baseline, 24 months
Prodromal Questionnaire - Brief
This is a self-report screening measure for psychosis risk syndromes. It records psychosis-like symptoms that would have occurred over the past month. For each item in the questionnaire that is endorsed, responses range in levels of distress or impairment from a scale of 1 (strongly disagree) to 5 (strongly agree).
Measured: Baseline
Structured Interview for Prodromal Symptoms (SIPS) Negative/Disorganized Subscales
The Structured Interview for Prodromal Symptoms Negative/Disorganized Subscales is a diagnostic semi-structured interview used to assess the severity of symptoms and diagnose prodromal syndromes.
Measured: Baseline
The Adolescent Alcohol and Drug Involvement Scale
The Adolescent Alcohol and Drug Involvement Scale (AADIS) Revised is a self-report measure of adolescent problematic substance abuse, and will be used to quantify frequency of past-year substance use (including cannabis use). This scale also provides a numerical score derived from items related to behaviors associated with problematic use. Total scores can range from a minimum of 0 to a maximum of 84, with higher scores indicating more frequent use of substances.
Measured: Baseline
Assessment of Educational Attainment
Participants will be asked to fill in a self-report questionnaire measuring educational attainment which takes about 5 minutes to complete. The revised Educational Attainment Questionnaire will assess level of education, grades and accommodations or other support at school among other education-related items. Participants fill in the Educational Attainment Questionnaire at baseline. The Educational Attainment Questionnaire is composed of several items from the School Mental Health Survey that is part of the Ontario Child Health Study, a longstanding prospective study on the overall health of children in Ontario.
Measured: Baseline
Social Responsiveness Scale - Long Form
Autism spectrum symptoms will be evaluated using the long form of the Social Responsiveness Scale (SRS-2), which is a validated brief measure of autism traits consisting of 65 items. Caregivers will complete the caregiver report school version. Total scores can range from a minimum of 65 to a maximum of 260, with higher scores indicating the presence of more autism traits.
Measured: Baseline
Columbia Impairment Scale
The Columbia Impairment Scale (CIS) is a 13-item self and caregiver report scale which provides a global measure of impairment in 4 major areas of functioning: interpersonal relations (family and friends), broad psychopathological domains, job or school functioning, and use of leisure time. Total scores can range from a minimum of 0 to a maximum of 52, with higher scores indicating more global impairment.
Measured: Baseline
Global Functioning: Social and Role Scales - Brief
The Global Functioning: Social and Role Scales assessment measures social and role functioning through a semi-structured interview. Total scores can range from a minimum of 1 to a maximum of 10, with higher scores indicating greater functioning.
Measured: Baseline
Self-report World Health Organization - Disability Assessment Schedule
The Self-report World Health Organization - Disability Assessment Schedule is a 12-item generic assessment instrument for health and disability. This tool produces standardized disability levels and profiles directly linked at the level of the concepts to the International Classification of Functioning, Disability and Health (ICF), and covers six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. Total scores can range from a minimum of 0 to a maximum of 48, with higher scores indicating lower functioning.
Measured: Baseline
Health and Social Service Utilization measure
Youth will be asked to self-report their mental health and other health and social service utilization using an adapted version of the Health and Social Service Utilization measure that has been previously used with this population, including in the current Longitudinal Youth in Transition Study at the Centre for Addiction and Mental Health (CAMH). Additional items are adapted from the Ontario Student Drug Use and Health Survey.
Measured: 6 months
Transition Readiness Assessment Questionnaire
The Transition Readiness Assessment Questionnaire (TRAQ) will be used to assess the transition readiness of youth between the ages of 15 and 19 from youth to adult mental health services. Total scores can range from a minimum of 20 to a maximum of 100, with higher scores indicating greater transition readiness.
Measured: 6 months
Internet Addiction Test
The Internet Addiction Test measures the presence and severity of problematic internet use across six addictive domains: Conflict, Mood Modification, Salience, Tolerance, Relapse, and Withdrawal.
Measured: Baseline
Parent Child Internet Addiction Test
The Parent Child Internet Addiction Test measures the presence and severity of problematic internet use. This test is a 20-item measure asking the parent to indicate the frequency of behaviours in the child on a 6-point scale ranging from 'Does not apply' to 'Always'.
Measured: Baseline
Leisure Time Questionnaire
The Leisure Time Questionnaire is used to assess time spent in leisure activities.
Measured: Baseline, 6 months
MRI Scan
Youth participants enrolled in the deep phenotyping cohort will be asked to complete an MRI scan at their participating site for approximately 1 hour. Each scan will consist of high-quality T1-weighted, diffusion MRI (dMRI) and r-fMRI sequences that will be combined into a single neuroimaging output per participant.
Measured: Baseline
Edinburgh Handedness Inventory - Brief
The Edinburgh Handedness Inventory (EHI) - Brief is a four-item questionnaire used to assess laterality. Youth are asked to report the dominance of the right or left hand in everyday activities. Scores range from -100 (indicating left preference) to 100 (indicating right preference).
Measured: Baseline
The Snellen Chart
The Snellen Chart is an eye chart commonly used to assess visual acuity using eleven lines of block letters. Participants are asked to stand ten feet from the chart and to read the letters of each row aloud, beginning from the top row.
Measured: Baseline
Toolbox Dimensional Change Card Sort Task
The Toolbox Dimensional Change Card Sort Task assesses cognitive flexibility. Youth are presented with two stimuli at the bottom of the screen and asked to sort a third stimulus presented in the middle of the screen to match one of the two stimuli at the bottom, by either colour or shape.
Measured: Baseline
Toolbox Flanker Task
The Toolbox Flanker Task assesses attention and inhibitory control. Youth are presented with a target stimulus and two surrounding flanker stimuli, and are asked to indicate which direction the middle stimulus is facing (left or right); surrounding flanker stimuli may be facing in the same direction (congruent trials) or the opposite direction (incongruent trials).
Measured: Baseline
Toolbox List Sorting Working Memory Test
The Toolbox List Sorting Working Memory Test assesses working memory sequencing skills. Youth are presented with animals and foods of assorted sizes both visually and auditorily, and asked to list the items presented from smallest to largest. This test is repeated using items from a single category, and items from two categories; in the latter, youth are requested to list items from one category and then the other.
Measured: Baseline
Toolbox Oral Reading Recognition Task
The Toolbox Oral Reading Recognition Task assesses language exposure and reading skills. Youth are asked to pronounce visually presented letters or words.
Measured: Baseline
Toolbox Pattern Comparison Processing Speed Test
The Toolbox Pattern Comparison Processing Speed Test assesses visual processing. Youth are asked to determine whether two visually presented pictures are the same.
Measured: Baseline
Toolbox Picture Sequence Memory Test
The Toolbox Picture Sequence Memory Test assesses episodic memory. Youth are presented with 15 pictures demonstrating events and are asked to model those events as a series of actions using props.
Measured: Baseline
Toolbox Picture Vocabulary Task
The Toolbox Picture Vocabulary Task assesses language and verbal intellect. Participants are auditorily presented with a word and asked to choose which of four visually presented pictures matches that word.
Measured: Baseline
Rey Auditory Verbal Learning Test
The Rey Auditory Verbal Learning Test (RAVLT) assesses auditory learning and memory. Youth are asked to listen to and recall a list of 15 unrelated words over five learning trials. They are then presented with and asked to recall as many words from a second, distractor list of 15 words, and recall of the initial list is then assessed.
Measured: Baseline
Wechsler Intelligence Test for Children-V Matrix Reasoning
This subtest of the Wechsler Intelligence Scale for Children assesses nonverbal reasoning, as well as visual intelligence, part-whole spatial reasoning, perceptual organization, attention to visual detail, and sequencing. Youth are presented with an incomplete array of visually presented stimuli, and asked to select one of four alternatives to complete the array. For participants aged 16 years or over, the Wechsler Adult Intelligence Scale-IV (WAIS-IV) version of this task will be administered.
Measured: Baseline
Little Man Task
The Little Man Task (LMT) assesses visual-spatial processing, including mental rotation. Youth are asked to indicate which hand a figure is using to hold a briefcase after being presented with the figure in one of four positions.
Measured: Baseline
Delay Discounting Task
Delay discounting can be defined as the depreciation of the value of a reward related to the time that it takes to be released. The task is an index of impulsive behaviour. Participants play a game in which they make a choice between an immediate small reward and a delayed larger reward.
Measured: 6 months
Emotional Stroop Task
The Emotional Stroop Task is a modified version of the traditional Stroop task in which participants are required to name the ink color of words with emotional or neutral valence. This task is commonly used to measure the attentional biases toward emotional stimuli typically observed in humans.
Measured: 6 months
Penn Emotion Differentiation Task
The Penn Emotion Differentiation Task measures the social cognition domain of emotion identification - the ability to decode and correctly identify facial expressions of emotion. Youth are shown 40 faces and must determine whether the emotion expressed is happiness, sadness, anger, fear, or none at all.
Measured: 6 months
The Awareness of Social Inference Test (TASIT) - Short Version
The Awareness of Social Inference Test (TASIT) - Short Version measures social cognition using videos of naturalistic everyday conversations in which two actors interact. It has established ecological validity, reliability and construct validity. Alternate forms are available for re-testing.
Measured: 6 months
Parental Bonding Instrument
The Parental Bonding Instrument (PBI) was designed to measure the contribution of parental behavior to the development of appropriate bonds between parents and children. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Measured: Baseline
Personality Inventory for DSM-5 Faceted Brief Form
The Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) will be used to examine maladaptive personality traits. The PID-5-FBF is a 100-item self-rated personality trait assessment scale for adolescents and adults. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Measured: 6 months
Competitive Sports Questionnaire
This is an 8-item questionnaire originally developed for the TAY study.
Measured: 6 months
International Physical Activity Questionnaire
This measure is a questionnaire measuring physical activities in the last 7 days.
Measured: 6 months
Pain Questionnaire
This measure assesses types of pain and frequency, and the impact of pain on 5-point Likert scales. For each pain item the participant needs to indicate if pain can be explained by a physical accident or diagnosed medical condition.
Measured: 6 months
Puberty Development Scale
This scale contains five items, with the last two items being different for males and females. It assesses the presence of developmental changes associated with puberty. Total scores can range from a minimum of 5 to a maximum of 20, with higher scores indicating the presence of more developmental changes.
Measured: 6 months
Social Media Addiction Questionnaire
The Social Media Addiction Questionnaire (SMAQ) is comprised of questions adapted from the Ontario Student Drug Use and Health Survey. These questions will be used to collect information on screen time use, problematic social media use and video game use, respectively, as reported by the youth participant. Total scores can range from a minimum of 6 to a maximum of 36, with higher scores indicating more problematic use of social media.
Measured: Baseline
Acculturation Questionnaire
The Acculturation Questionnaire will be used to measure speaking and reading skills in English and language preference. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Measured: 6 months
Mexican American Cultural Values Scale
The Mexican American Cultural Values Scale (50 items) is used to assess family values of individuals from diverse cultural backgrounds. Total scores can range from a minimum of 50 to a maximum of 250, with higher scores indicating less adherence to the outlined cultural values.
Measured: 6 months
Multigroup Ethnic Identity-Revised
The Multigroup Ethnic Identity-Revised will be used to measure cultural affiliation. This measure contains 6 items that can be rated on a five-point scale from strongly disagree to strongly agree. Total scores can range from a minimum of 6 to a maximum of 24, with higher scores indicating stronger cultural affiliation.
Measured: 6 months
Vancouver Index of Acculturation - Short
The Vancouver Index of Acculturation - Short will be used to measure acculturation with 20 items that can be rated from disagree to agree on a 9-point scale. Total scores can range from a minimum of 10 to a maximum of 90, with higher scores indicating greater acculturation.
Measured: 6 months
Parental Monitoring
Family and social influences including parental monitoring and interactions with family members will be measured using the Parental Monitoring questionnaire. Total scores can range from a minimum of 5 to a maximum of 25, with higher scores indicating higher parental involvement.
Measured: 6 months
Prosocial Scale from the Strengths and Difficulties Questionnaire
Family and social influences including prosocial behaviors and interactions with family members will be measured using the Prosocial Scale. Total scores can range from a minimum of 0 to a maximum of 10, with higher scores indicating more prosocial behaviors.
Measured: 6 months
Conflict Behavior Questionnaire
Family and social influences including interactions with family members will be measured using the Conflict Behavior Questionnaire. Total scores can range from a minimum of 0 to a maximum of 20, with higher scores indicating the presence of more conflict-related behaviors.
Measured: 6 months
Gender Dysphoria Questionnaire for Adolescents and Adult
In addition to self-reported gender obtained using the demographic protocol, gender expression will be measured using the Gender Dysphoria Questionnaire for Adolescents and Adults. Total scores can range from a minimum of 27 to a maximum of 135, with higher scores indicating greater satisfaction and less gender-related distress.
Measured: 6 months
Personal Attributes Questionnaire
In addition to self-reported gender obtained using the demographic protocol, gender identity variability will be measured using the Personal Attributes Questionnaire. Total scores can range from a minimum of 0 to a maximum of 96, with higher scores indicating stronger self-perceptions of gender attributes.
Measured: 6 months
Adverse Life Events Scale
Life events and current life stress will be assessed in all participants below age 18 using The Adverse Life Events Scale. Total scores can range from a minimum of 0 to a maximum of 25, with higher scores indicating more adverse life events and/or related stress.
Measured: 6 months
Childhood Trauma Questionnaire - Short Form
All participants will be administered the Childhood Trauma Questionnaire - Short Form to identify traumatic childhood conditions. Total scores can range from a minimum of 28 to a maximum of 125, with higher scores indicating greater exposure to traumatic childhood conditions.
Measured: 6 months
Connor-Davidson Resilience Scale
Individual resilience in the face of stress will be measured using a brief, two-item version of the Connor-Davidson Resilience Scale. Total scores can range from a minimum of 0 to a maximum of 8, with higher scores indicating higher resilience.
Measured: 6 months
Everyday Discrimination Scale
Lifetime discriminatory experiences will be assessed in all participants using a Canadian adaptation of the Everyday Discrimination Scale. Total scores can range from a minimum of 5 to a maximum of 25, with higher scores indicating greater discriminatory experiences.
Measured: 6 months
Life Events Checklist
The Life Events Checklist (LEC) is designed to screen for potentially traumatic experiences that may contribute to psychological distress. Participants aged 18 and above will be administered the Life Events Checklist.
Measured: 6 months
Inventory for School Risk and Protective Factors
All participants' school environments will be characterized using the Inventory for School Risk and Protective Factors measure from the ABCD study. Total scores can range from a minimum of 6 to a maximum of 24, with higher scores indicating greater protective factors.
Measured: 6 months
Neighbourhood Safety and Crime Scale
In the proximal social environment, neighbourhood safety will be measured using a three-item Neighbourhood Safety and Crime Scale. Total scores can range from a minimum of 3 to a maximum of 15, with higher scores indicating lower perceived neighbourhood safety.
Measured: 6 months
3-Digit Postal Codes
3-digit postal codes of participants (collected as part of routine demographic data) will be used to obtain census-based neighbourhood-level marginalization data; this will allow each participant's neighbourhood to be characterized by the level of social and economic marginalization as well as ethnic concentration. At the time of cohort entry, the first 3 digits of each participant's postal code are collected based on the participant's residential address. Any change in a participant's residential address will also be recorded during assessment periods during the study to account for changes in exposure to socio-environmental factors.
Measured: Baseline
Parent General Behaviour Inventory-10 Mania
Caregivers will complete the Parent General Behaviour Inventory-10 Mania, which measures the presence and severity of mania. Total scores can range from a minimum of 0 to a maximum of 30, with higher scores indicating greater presence and severity of mania.
Measured: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Video Game Addiction Questionnaire
The Video Game Addiction Questionnaire (VGAQ) is comprised of questions adapted from the Ontario Student Drug Use and Health Survey. These questions will be used to collect information on screen time use, problematic social media use and video game use, respectively, as reported by the youth participant. Total scores can range from a minimum of 6 to a maximum of 36, with higher scores indicating more problematic use of video games.
Measured: Baseline
Student Adaptation to College Questionnaire
The Student Adaptation to College Questionnaire (SACQ) is a self-report questionnaire measuring educational attainment. Participants attending post-secondary school will also be asked to complete the SACQ. Total scores can range from a minimum of 67 to a maximum of 603, with higher scores indicating better overall adjustment to college life.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start4 Mar 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (104)Papers the sponsor has linked to this study.
- Other trials for Multiple Mental Health ConditionsStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Brain Institute
- Responsible party
- Sponsor
- Investigators
- Louise Gallagher, MB, BCh, PhD, Principal investigator, Centre for Addiction and Mental HealthPaul Arnold, MD, PhD, Principal investigator, University of CalgaryGary Goldfield, PhD, C. Psych., Principal investigator, The Children's Hospital of Eastern Ontario Research InstituteStephanie Ameis, MD, MSc, Principal investigator, Centre for Addiction and Mental HealthSuneeta Monga, MD, FRCPC, Principal investigator, The Hospital for Sick ChildrenMelissa Kimber, PhD, MSW, RSW, Principal investigator, Hamilton Health Sciences CorporationJennifer Phillips, PhD, Principal investigator, The University of Ottawa Institute of Mental Health Research at the RoyalNicole Racine, PhD, C. Psych., Principal investigator, The Children's Hospital of Eastern Ontario Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699159
- Sponsor's protocol ID
- 4792
- Acronym
- CALM
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from this project may be used for future research by internal project collaborators. De-identified and anonymized data from this research study will be deposited to site specific database repositories for future use. Data will be shared with third-parties for secondary use via the Brain-CODE Platform. Third-parties will own the derived outputs such as new data and analyses (the Work Product) that result from their use of the data. Ontario Brain Institute - Brain-CODE Participation Agreement: The Centre for Ontario Data Exploration (Brain-CODE), is an informatics platform established by the Ontario Brain Institute to facilitate and expedite the investigation, discovery, or scientific query within and/or across several health conditions. All participating sites in CALM, including CAMH have signed Brain-CODE Participation Agreements with OBI agreeing to contribute data to Brain-CODE.
Publications
Zabihi M, Floris DL, Kia SM, Wolfers T, Tillmann J, Arenas AL, Moessnang C, Banaschewski T, Holt R, Baron-Cohen S, Loth E, Charman T, Bourgeron T, Murphy D, Ecker C, Buitelaar JK, Beckmann CF, Marquand A; EU-AIMS LEAP Group. Fractionating autism based on neuroanatomical normative modeling. Transl Psychiatry. 2020 Nov 6;10(1):384. doi: 10.1038/s41398-020-01057-0.
PubMed 33159037Youngstrom EA, Frazier TW, Demeter C, Calabrese JR, Findling RL. Developing a 10-item mania scale from the Parent General Behavior Inventory for children and adolescents. J Clin Psychiatry. 2008 May;69(5):831-9. doi: 10.4088/jcp.v69n0517.
PubMed 18452343Young, K. S. (1998). Internet Addiction: The Emergence of a New Clinical Disorder. CyberPsychology & Behavior, 1(3), 237-244. https://doi.org/10.1089/cpb.1998.1.237
Wood DL, Sawicki GS, Miller MD, Smotherman C, Lukens-Bull K, Livingood WC, Ferris M, Kraemer DF. The Transition Readiness Assessment Questionnaire (TRAQ): its factor structure, reliability, and validity. Acad Pediatr. 2014 Jul-Aug;14(4):415-22. doi: 10.1016/j.acap.2014.03.008.
PubMed 24976354Wolfers T, Rokicki J, Alnaes D, Berthet P, Agartz I, Kia SM, Kaufmann T, Zabihi M, Moberget T, Melle I, Beckmann CF, Andreassen OA, Marquand AF, Westlye LT. Replicating extensive brain structural heterogeneity in individuals with schizophrenia and bipolar disorder. Hum Brain Mapp. 2021 Jun 1;42(8):2546-2555. doi: 10.1002/hbm.25386. Epub 2021 Feb 27.
PubMed 33638594Wolfers T, Beckmann CF, Hoogman M, Buitelaar JK, Franke B, Marquand AF. Individual differences v. the average patient: mapping the heterogeneity in ADHD using normative models. Psychol Med. 2020 Jan;50(2):314-323. doi: 10.1017/S0033291719000084. Epub 2019 Feb 14.
PubMed 30782224Wechsler Intelligence Scale for Children | Fifth Edition. (n.d.). Retrieved April 17, 2024, from https://www.pearsonassessments.com/store/usassessments/en/Store/Professional-Assessments/Cognition-%26-Neuro/Wechsler-Intelligence-Scale-for-Children-%7C-Fifth-Edition-/p/100000771.html
Veale JF. Edinburgh Handedness Inventory - Short Form: a revised version based on confirmatory factor analysis. Laterality. 2014;19(2):164-77. doi: 10.1080/1357650X.2013.783045. Epub 2013 May 10.
PubMed 23659650Uhlhaas PJ, Davey CG, Mehta UM, Shah J, Torous J, Allen NB, Avenevoli S, Bella-Awusah T, Chanen A, Chen EYH, Correll CU, Do KQ, Fisher HL, Frangou S, Hickie IB, Keshavan MS, Konrad K, Lee FS, Liu CH, Luna B, McGorry PD, Meyer-Lindenberg A, Nordentoft M, Ongur D, Patton GC, Paus T, Reininghaus U, Sawa A, Schoenbaum M, Schumann G, Srihari VH, Susser E, Verma SK, Woo TW, Yang LH, Yung AR, Wood SJ. Towards a youth mental health paradigm: a perspective and roadmap. Mol Psychiatry. 2023 Aug;28(8):3171-3181. doi: 10.1038/s41380-023-02202-z. Epub 2023 Aug 14.
PubMed 37580524Tiet QQ, Bird HR, Davies M, Hoven C, Cohen P, Jensen PS, Goodman S. Adverse life events and resilience. J Am Acad Child Adolesc Psychiatry. 1998 Nov;37(11):1191-200. doi: 10.1097/00004583-199811000-00020.
PubMed 9808931The Ontario Student Drug Use and Mental Health Survey (OSDUHS). (n.d.). CAMH. Retrieved May 1, 2024, from https://www.camh.ca/en/science-and-research/institutes-and-centres/institute-for-mental-health-policy-research/ontario-student-drug-use-and-health-survey---osduhs
The Hospital for Sick Children Research Ethics Board Blood Sampling Guidelines. (n.d.). Retrieved March 10, 2025, from https://www.sickkids.ca/siteassets/research/reb/research-ethics-guidelines/sickkids-reb-blood-volume-guidelines-2020-2021.pdf
The Diagnostic Assessment of the Spectrum of Health (DASH): Properties, advantages and clinical utility in the context of of structured diagnostic interviews for adults and youth mental health | NIH Research Festival. (n.d.). Retrieved March 10, 2025, from https://researchfestival.nih.gov/2024/posters/diagnostic-assessment-spectrum-health-dash-properties-advantages-and
Ustun TB, Chatterji S, Kostanjsek N, Rehm J, Kennedy C, Epping-Jordan J, Saxena S, von Korff M, Pull C; WHO/NIH Joint Project. Developing the World Health Organization Disability Assessment Schedule 2.0. Bull World Health Organ. 2010 Nov 1;88(11):815-23. doi: 10.2471/BLT.09.067231. Epub 2010 May 20.
PubMed 21076562Brainstorm Consortium; Anttila V, Bulik-Sullivan B, Finucane HK, Walters RK, Bras J, Duncan L, Escott-Price V, Falcone GJ, Gormley P, Malik R, Patsopoulos NA, Ripke S, Wei Z, Yu D, Lee PH, Turley P, Grenier-Boley B, Chouraki V, Kamatani Y, Berr C, Letenneur L, Hannequin D, Amouyel P, Boland A, Deleuze JF, Duron E, Vardarajan BN, Reitz C, Goate AM, Huentelman MJ, Kamboh MI, Larson EB, Rogaeva E, St George-Hyslop P, Hakonarson H, Kukull WA, Farrer LA, Barnes LL, Beach TG, Demirci FY, Head E, Hulette CM, Jicha GA, Kauwe JSK, Kaye JA, Leverenz JB, Levey AI, Lieberman AP, Pankratz VS, Poon WW, Quinn JF, Saykin AJ, Schneider LS, Smith AG, Sonnen JA, Stern RA, Van Deerlin VM, Van Eldik LJ, Harold D, Russo G, Rubinsztein DC, Bayer A, Tsolaki M, Proitsi P, Fox NC, Hampel H, Owen MJ, Mead S, Passmore P, Morgan K, Nothen MM, Rossor M, Lupton MK, Hoffmann P, Kornhuber J, Lawlor B, McQuillin A, Al-Chalabi A, Bis JC, Ruiz A, Boada M, Seshadri S, Beiser A, Rice K, van der Lee SJ, De Jager PL, Geschwind DH, Riemenschneider M, Riedel-Heller S, Rotter JI, Ransmayr G, Hyman BT, Cruchaga C, Alegret M, Winsvold B, Palta P, Farh KH, Cuenca-Leon E, Furlotte N, Kurth T, Ligthart L, Terwindt GM, Freilinger T, Ran C, Gordon SD, Borck G, Adams HHH, Lehtimaki T, Wedenoja J, Buring JE, Schurks M, Hrafnsdottir M, Hottenga JJ, Penninx B, Artto V, Kaunisto M, Vepsalainen S, Martin NG, Montgomery GW, Kurki MI, Hamalainen E, Huang H, Huang J, Sandor C, Webber C, Muller-Myhsok B, Schreiber S, Salomaa V, Loehrer E, Gobel H, Macaya A, Pozo-Rosich P, Hansen T, Werge T, Kaprio J, Metspalu A, Kubisch C, Ferrari MD, Belin AC, van den Maagdenberg AMJM, Zwart JA, Boomsma D, Eriksson N, Olesen J, Chasman DI, Nyholt DR, Avbersek A, Baum L, Berkovic S, Bradfield J, Buono RJ, Catarino CB, Cossette P, De Jonghe P, Depondt C, Dlugos D, Ferraro TN, French J, Hjalgrim H, Jamnadas-Khoda J, Kalviainen R, Kunz WS, Lerche H, Leu C, Lindhout D, Lo W, Lowenstein D, McCormack M, Moller RS, Molloy A, Ng PW, Oliver K, Privitera M, Radtke R, Ruppert AK, Sander T, Schachter S, Schankin C, Scheffer I, Schoch S, Sisodiya SM, Smith P, Sperling M, Striano P, Surges R, Thomas GN, Visscher F, Whelan CD, Zara F, Heinzen EL, Marson A, Becker F, Stroink H, Zimprich F, Gasser T, Gibbs R, Heutink P, Martinez M, Morris HR, Sharma M, Ryten M, Mok KY, Pulit S, Bevan S, Holliday E, Attia J, Battey T, Boncoraglio G, Thijs V, Chen WM, Mitchell B, Rothwell P, Sharma P, Sudlow C, Vicente A, Markus H, Kourkoulis C, Pera J, Raffeld M, Silliman S, Boraska Perica V, Thornton LM, Huckins LM, William Rayner N, Lewis CM, Gratacos M, Rybakowski F, Keski-Rahkonen A, Raevuori A, Hudson JI, Reichborn-Kjennerud T, Monteleone P, Karwautz A, Mannik K, Baker JH, O'Toole JK, Trace SE, Davis OSP, Helder SG, Ehrlich S, Herpertz-Dahlmann B, Danner UN, van Elburg AA, Clementi M, Forzan M, Docampo E, Lissowska J, Hauser J, Tortorella A, Maj M, Gonidakis F, Tziouvas K, Papezova H, Yilmaz Z, Wagner G, Cohen-Woods S, Herms S, Julia A, Rabionet R, Dick DM, Ripatti S, Andreassen OA, Espeseth T, Lundervold AJ, Steen VM, Pinto D, Scherer SW, Aschauer H, Schosser A, Alfredsson L, Padyukov L, Halmi KA, Mitchell J, Strober M, Bergen AW, Kaye W, Szatkiewicz JP, Cormand B, Ramos-Quiroga JA, Sanchez-Mora C, Ribases M, Casas M, Hervas A, Arranz MJ, Haavik J, Zayats T, Johansson S, Williams N, Dempfle A, Rothenberger A, Kuntsi J, Oades RD, Banaschewski T, Franke B, Buitelaar JK, Arias Vasquez A, Doyle AE, Reif A, Lesch KP, Freitag C, Rivero O, Palmason H, Romanos M, Langley K, Rietschel M, Witt SH, Dalsgaard S, Borglum AD, Waldman I, Wilmot B, Molly N, Bau CHD, Crosbie J, Schachar R, Loo SK, McGough JJ, Grevet EH, Medland SE, Robinson E, Weiss LA, Bacchelli E, Bailey A, Bal V, Battaglia A, Betancur C, Bolton P, Cantor R, Celestino-Soper P, Dawson G, De Rubeis S, Duque F, Green A, Klauck SM, Leboyer M, Levitt P, Maestrini E, Mane S, De-Luca DM, Parr J, Regan R, Reichenberg A, Sandin S, Vorstman J, Wassink T, Wijsman E, Cook E, Santangelo S, Delorme R, Roge B, Magalhaes T, Arking D, Schulze TG, Thompson RC, Strohmaier J, Matthews K, Melle I, Morris D, Blackwood D, McIntosh A, Bergen SE, Schalling M, Jamain S, Maaser A, Fischer SB, Reinbold CS, Fullerton JM, Guzman-Parra J, Mayoral F, Schofield PR, Cichon S, Muhleisen TW, Degenhardt F, Schumacher J, Bauer M, Mitchell PB, Gershon ES, Rice J, Potash JB, Zandi PP, Craddock N, Ferrier IN, Alda M, Rouleau GA, Turecki G, Ophoff R, Pato C, Anjorin A, Stahl E, Leber M, Czerski PM, Cruceanu C, Jones IR, Posthuma D, Andlauer TFM, Forstner AJ, Streit F, Baune BT, Air T, Sinnamon G, Wray NR, MacIntyre DJ, Porteous D, Homuth G, Rivera M, Grove J, Middeldorp CM, Hickie I, Pergadia M, Mehta D, Smit JH, Jansen R, de Geus E, Dunn E, Li QS, Nauck M, Schoevers RA, Beekman AT, Knowles JA, Viktorin A, Arnold P, Barr CL, Bedoya-Berrio G, Bienvenu OJ, Brentani H, Burton C, Camarena B, Cappi C, Cath D, Cavallini M, Cusi D, Darrow S, Denys D, Derks EM, Dietrich A, Fernandez T, 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KC, Nenadic I, van Os J, Pantelis C, Pato M, Petryshen T, Quested D, Roussos P, Sanders AR, Schall U, Schwab SG, Sim K, So HC, Stogmann E, Subramaniam M, Toncheva D, Waddington J, Walters J, Weiser M, Cheng W, Cloninger R, Curtis D, Gejman PV, Henskens F, Mattingsdal M, Oh SY, Scott R, Webb B, Breen G, Churchhouse C, Bulik CM, Daly M, Dichgans M, Faraone SV, Guerreiro R, Holmans P, Kendler KS, Koeleman B, Mathews CA, Price A, Scharf J, Sklar P, Williams J, Wood NW, Cotsapas C, Palotie A, Smoller JW, Sullivan P, Rosand J, Corvin A, Neale BM, Schott JM, Anney R, Elia J, Grigoroiu-Serbanescu M, Edenberg HJ, Murray R. Analysis of shared heritability in common disorders of the brain. Science. 2018 Jun 22;360(6395):eaap8757. doi: 10.1126/science.aap8757.
PubMed 29930110
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM): A Master Observational Trial
- ClinicalTrials.gov ID
- NCT07699159
- Acronym / sponsor ID
- CALM / 4792
- Keywords
- multiple mental health conditions, child and youth mental health, mental health multimorbidity, master observational trial, deep phenotyping cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,620 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Ontario Brain Institute
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM) Master Observational Trial is a prospective, longitudinal observational study that seeks to improve clinical care for youth with multiple mental health conditions (MMHC), also known as mental health multimorbidity in the literature. MMHC is conceptualized as the presence of two or more mental health diagnoses under the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). MMHC is common in youth seeking mental health services and is associated with less favorable outcomes and greater health services utilization. Mental health disorders also accumulate in youth over time. The Master Observational Trial (MOT) will investigate MMHC in critical developmental periods in youth and identify risk and protective factors that will provide a mechanistic understanding of how MMHC develops over time. A subset of participants will also enroll in a Deep Phenotyping Cohort, which includes enhanced clinical and cognitive assessments and multimodal neuroimaging to investigate neurobiological mechanisms underlying MMHC and identify potential biomarkers of illness complexity and progression.
In the near future, we aim to add to the current protocol to embed both a clinical trials network for youth mental health in Ontario and Calgary within the CALM study and add digital phenotyping using wearable technology to generate digital and physiological markers of MMHC. The current protocol focuses on establishing the longitudinal MOT cohort and Deep Phenotype Cohort only as a first step towards these long term CALM goals.
Detailed description
The primary objectives of the CALM MOT are to:
- Establish a prospective, longitudinal cohort of children and youth aged 11-24 years to characterize the progression and outcomes of MMHC over time.
- Facilitate later development of a clinical trials network and clinical research in MMHC with a focus on developing transdiagnostic interventions and improving care.
- Establish a deeply phenotyped cohort of youth in a subset of participants enrolled in the MOT (light phenotyping protocol), using multidimensional, multilevel data to investigate brain-based mechanisms of MMHC with potential for biomarker discovery.
Specific objectives of the Deep Phenotyping Cohort are to:
- Collect data across CALM sites in participants that are eligible and consent to participate in CALM MOT Light and the Deep Phenotyping Protocol. In this subset of CALM participants, we will extend the clinical/behavioural measurement battery, and collect high quality cognitive and multimodal (T1, multi-shell DWI, resting state, ASL) neuroimaging data that will be undertaken as part of the CALM baseline deep phenotyping protocol.
- Use open access brain age and centile score calculators using unimodal brain imaging data to examine centile score distributions for various data samples in a sex stratified manner (e.g., clinical/community ascertained) and associations between centile scores with behavioral/cognitive indices of clinical severity/impairment and MMHC (e.g., MMHC index). Available open access normative and clinically enriched neuroimaging samples that overlap with the proposed CALM sample age range (11-24 years) will be utilized.
- Undertake analysis using cross-sectional neuroimaging and longitudinal MOT data derived from the CALM network to test whether deviations from normative brain measures using either unimodal or integrating data from different imaging sequences (i.e., multimodal), imaging calculators may have utility as a baseline 'prognostic/predictive' marker of youth who may have more complex illness (i.e., MMHC) at the time of initial (baseline) participation in the CALM study and at subsequent time points and/or may be less responsive to clinical interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOT | – | –In the MOT/Light Protocol, clinical, and functional measures will be collected in addition to blood-based 'omics' including proteomic (immune markers) and genomic analysis of DNA derived from blood and/or saliva. Over 3 years n=1620 children and youth will be recruited to the MOT/Light Protocol across the CALM Network. A number of measures will be collected throughout the course of the study in order to capture symptoms across a spectrum of conditions in the target population. Provided that the main objective of the CALM project is to improve clinical care for youth with a particular focus on MMHC, it is vital to use validated standardized assessments that test highly prevalent physical and mental health conditions. MOT/Light measures will be collected via self-report (SR), rated-administered (RA), caregiver-administered (Ca), or a combination |
| Deep Phenotyping | – | –Multidimensional, multilevel data will be obtained in a subcohort of CALM Study youth (3 years n=~614) recruited to the MOT who also consent to participate in the Deep Phenotyping protocol. The Deep Phenotyping Protocol includes additional clinical, behavioural, developmental and functional outcomes, not collected as part of the light phenotyping battery as well as the collection of neurocognitive measures and neuroimaging data. Cognitive phenotyping will be administered at 0 and 6 month time points. Neuroimaging will be collected at one time point, harmonized across sites using human connectome quality scanning and to key external initiatives (e.g., neuroimaging via ABCD) facilitating secondary data use, and the utilization of additional cohorts in analysis. |
Who may qualify
- Ages
- 11 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The CALM network will recruit children and youth aged 11-24 who have sought, are seeking, or are accessing mental health care from 5 partner sites in Ontario (Centre for Addiction and Mental Health, Hospital for Sick Children, McMaster Children's Hospital, Children's Hospital of Eastern Ontario, and The Royal Ottawa Mental Health Centre) and 1 partner site in Alberta (Alberta Health Services) as well as the broader community. Caregivers of CALM participants will be asked to complete caregiver specific questionnaires (self-report and completing the measures based on their child/youth). When a CALM child/youth participant is approached for the study, we will ask said participant if we can contact their caregiver to participate in the study. We will then approach the caregiver for consent. No external recruitment of non-CALM participants caregivers will be implemented.
Key inclusion criteria (7 listed)
- The participant must meet all of the inclusion criteria to be eligible for this research study:
- Light Phenotype Eligibility Must sign and date the informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent; Aged 11-24 years old at the time of screening; Any person within age criteria who has previously sought, is seeking, or is accessing mental health services; Are able to complete assessments in English.
- Deep Phenotype Eligibility Must be part of the CALM light phenotype cohort; Must sign and date the deep phenotyping informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent.
- Any caregiver of a CALM child/youth participant is eligible to participate in the study, insofar as the child/youth participant has consented to the light phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.
- Any caregiver of a CALM child/youth participant is eligible to participate in the study, insofar as the child/youth participant has consented to the deep phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this research study:
- Light Phenotype Does not provide informed consent (for those with the capacity to consent) or assent (for those who lack the capacity to consent); For those individuals who lack the capacity to consent, the inability of the parent/legal guardian to provide informed consent for the youth is also an exclusion criterion; Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.
- Deep Phenotype Unable to participate in deep phenotyping protocol (e.g., MRI contraindication, uncorrected vision or hearing impairments that would interfere with data collection, unwillingness to complete assessments); No exclusion criteria are based on race, ethnicity, sex or gender.
- Caregivers of CALM child/youth participants are ineligible to participate in the study if:
- The child/youth participant does not agree for their caregiver to be contacted to participate in the study; The child/youth participant is not participating in the light phenotype cohort; Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Assessment for the Health Spectrum
Time frame: Baseline and 24 months
The Diagnostic Assessment for the Health Spectrum (DASH) is a semi-structured screener and interview that evaluates a broad range of psychiatric symptoms and associated symptoms. It also assesses a number of physical health symptoms. The DASH is based on the core structure of the Schedule for Affective Disorders and Schizophrenia-SADS and Kiddie-SADS, and includes features of a number of other structured interviews of psychopathology. It provides a diagnostic spectrum in addition to categorical diagnoses that are aligned to the DSM-IV and DSM-5. The completed interview yields a narrative report and summary for clinicians and researchers. There are three versions (adult, child, and parent on child) which take approximately 90-240+ minutes to complete.
Adolescent Health History
Time frame: Baseline, 12 months, 24 months
Youth and caregivers will be asked to self-report the presence of health conditions using the Adolescent Health History measure to indicate whether the youth has in the past or currently has any of over 40 common mental or physical health conditions listed. Youth will also be able to add up to four other conditions not listed.
Assessment of Quality of Life
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Assessment of Quality of Life (AQoL) measures 5 dimensions: illness, independent living, social relationships, physical senses and psychological well being. Each dimension is measured by three items (a total of 15 items). Total scores can range from a minimum of 20 to a maximum of 99, with higher scores indicating poorer quality of life.
Brain-CODE Demographic Form
Time frame: Baseline, 12 months, 24 months
The Brain-CODE Demographic Form is a standard form developed by Brain-CODE to capture demographic information from participants.
Brain-CODE Medical History Form incorporating Developmental History Questionnaire (DHQ) Items
Time frame: Baseline, 12 months, 24 months
The Brain-CODE Medical History Form is a standard form developed by Brain-CODE to capture medical history in participants.
Canadian Health Survey on Children and Youth (CHSCY) Childhood Experiences Scale
Time frame: Baseline, 12 months, 24 months
The Canadian Health Survey on Children and Youth (CHSCY) Childhood Experiences Scale includes 10 items assessing youth's self-reported exposure to different forms of maltreatment by their caregivers, including physical, sexual and emotional abuse, neglect, as well as exposure to violence between caregivers. One additional item captures youth's exposure to corporal punishment. Items have been administered in population-based studies that include samples of youth and adults, as well as clinical observational studies and trials. Total scores can range from a minimum of 10 to a maximum of 50, with higher scores indicating more negative experiences.
Child and Youth Resilience Measure
Time frame: Baseline, 12 months, 24 months, 36 months
The Child and Youth Resilience Measure is a screening tool to explore the resources (individual, relational, communal and cultural) available to individuals that may bolster their resilience. Individuals aged 24+ will be asked to complete the Adult Resilience Measure. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
The Columbia Suicide Severity Rating Scale
Time frame: Baseline, 24 months
The Columbia Suicide Severity Rating Scale is a validated and widely used rater-administered measure of suicidal ideation and behaviour, and non-suicidal self-injury. It will be administered to all participants. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Self-Injurious Thoughts and Behaviours Interview
Time frame: Baseline, 24 months
The Self-Injurious Thoughts and Behaviours Interview (SITBI) measures self-injurious thoughts and behaviors.
Canadian Health Survey on Children and Youth (CHSCY) Bullying Scale
Time frame: Baseline, 12 months, 24 months
The Canadian Health Survey on Children and Youth (CHSCY) Bullying Scale includes 10 items and is designed to assess youth exposure to bullying in the preceding 12 months. Items capture both the type and frequency of bullying, with types of bullying covered by the measure including verbal, physical, relational, and online forms of bullying. Response options are captured on an ordinal scale encompassing: Never, A few Times a Year, Monthly, Weekly, Daily. Total scores can range from a minimum of 10 to a maximum of 50, with higher scores indicating more experiences with bullying.
Difficulties in Emotion Regulation Scale Short Form
Time frame: Baseline, 12 months, 24 months, 36 months
The Difficulties in Emotion Regulation Scale Short Form is an 18-item measure used to identify emotional regulation issues. The measure covers 4 dimensions of emotional regulation: awareness and understanding of emotions; acceptance of emotions; the ability to engage in goal-directed behavior and refrain from impulsive behavior when experiencing negative emotions; and access to emotion regulation strategies perceived as effective. Total scores can range from a minimum of 18 to a maximum of 90, with higher scores indicating more difficulties with emotion regulation.
Eating Disorder Examination Questionnaire (EDE-QS) Short Form
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Eating Disorder Examination Questionnaire (EDE-QS) Short Form is a 12-item, self-report questionnaire capturing eating disorder symptoms. Response options are anchored on a 4-point ordinal response scale that captures symptoms over the preceding 7 days. Total scores can range from a minimum of 0 to a maximum of 36, with higher scores indicating the presence of more eating disorder symptoms.
General Anxiety Disorder-7
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
The General Anxiety Disorder-7 (GAD-7) measures presence and severity of Generalized Anxiety Disorder. Total scores can range from a minimum of 0 to a maximum of 21, with higher scores indicating greater presence and severity of anxiety symptoms.
General Behaviour Inventory-10 Mania
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
The General Behaviour Inventory-10 Mania measures the presence and severity of mania. Total scores can range from a minimum of 0 to a maximum of 30, with higher scores indicating greater presence and severity of mania.
General Life Satisfaction
Time frame: Baseline, 18 months, 30 months
A singular question from the Canadian Social Survey - Quality of Life and Energy Consumption Behaviours measure will be administered to determine life satisfaction. Total scores can range from a minimum of 0 to a maximum of 10, with higher scores indicating greater life satisfaction.
The Goal-Based Outcome (GBO) Tool
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Goal-Based Outcome (GBO) Tool aims to measure the progress and outcomes of an intervention in a simple way. It can be applied in any setting and is currently available in 9 languages. The child GBO tool contains a record sheet whereby up to 3 goals with their descriptions can be written down, followed by a goal rating sheet with descriptions and a scale ranging from 0 (Goals not at all met) to 10 (Goal reached). A goal progress chart at the end can be used to rate the progress of the goal across 12 sessions.
Internalized Stigma of Mental Illness
Time frame: Baseline
The Internalized Stigma of Mental Illness (ISMI) scale is a questionnaire measuring self-stigma among persons with psychiatric disorders. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
International Sedentary Assessment Tool
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
This measure consists of two parts. The first part has six items, and asks questions based on typical weekday activity in the last week. The second part also includes six items and asks questions pertaining to typical weekend activities within the last week. Higher scores equate to more sedentary behaviors in a participant.
McMaster Family Functioning Scale
Time frame: Baseline, 12 months, 24 months, 36 months
The McMaster Family Functioning Scale is a shorter 12-item assessment developed from The McMaster Family Assessment Device, which is a 60-item questionnaire that measures an individual's perceptions of their family. Total scores can range from a minimum of 12 to a maximum of 48, with higher scores indicating more positive perceptions of family.
Treatment Log
Time frame: Baseline, 6 months, 18 months, 24 months, 30 months, 36 months, 42 months
This inventory records prescribed treatment and medication, adherence and tolerability every 6 months.
Ohio State University Traumatic Brain Injury Identification Method
Time frame: 3 months, 30 months
The Ohio State University Traumatic Brain Injury Identification Method measures a participant's history of traumatic brain injury. Baseline and follow-up versions will be administered.
Ontario Child Health Study Emotional Behavioural Scales - Brief
Time frame: Baseline, 6 months, 24 months
The Ontario Child Health Study Emotional Behavioural Scales - Brief (OCHS-EBS-B) is a 25-item measurement tool for participants under the age of 18 that assesses common child/youth mental health disorders within the last 6 months. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Patient Global Improvement Scale
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Patient Global Improvement Scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status. Scores range from 0 to 7, with lower scores reflecting more positive symptoms and thus improvement in clinical status.
Patient Health Questionnaire
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
The Patient Health Questionnaire (PHQ) is a self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day).
Pittsburgh Sleep Quality Index
Time frame: Baseline
This assessment is designed to evaluate the overall sleep quality in a clinical population. It is a 19-item self-reported questionnaire assessing seven subcategories; use of sleeping medication, subjective sleep quality, sleep latency, duration, sleep efficiency, disturbances and dysfunction during the daytime. Each subcategory ranges from scores of 0 to 3, with higher scores reflecting poorer sleep patterns.
Phlebotomy (blood) collection
Time frame: Baseline, 12 months, 24 months
Blood will be collected by a trained phlebotomist or research nurse with experience working with children and youth. Blood will be collected at baseline, and then annually. A maximum of 40 mL of blood will be collected per participant; however, sites may collect reduced volumes due to site-specific procedures and/or participant limitations. To ensure sufficient sample volumes for clinical and genetic/immune analyses, a minimum collection threshold will be applied to each. Clinical testing (7-20 mL): Samples will be transferred to clinical labs for CBC, differential white cell count, HbA1C, CRP, glucose, and lipid testing. Genetic and immune analysis (16-20 mL): Samples will be analyzed for genetic, epigenetic, and immune markers. Sites will aim to collect the full 20 mL for both clinical and genetic testing whenever possible.
Physical Exam (Height, Weight, Body Mass Index, Waist Circumference, Neck Circumference, and Blood Pressure)
Time frame: Baseline, 12 months, 24 months, 36 months
A physical exam will be completed by trained research or clinical staff during the clinic visit. If the participant is unable to attend the clinic visit, research staff will use recent values from their medical record or provide instructions to the participant for measuring their height, weight, waist circumference and neck circumference at home (blood pressure will not be measured at home).
PRIME- Revised
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 42 months
This is a self-administered questionnaire that is designed to assess individuals at risk for developing a psychotic disorder. It contains 12 items that assess positive symptoms on a distress scale ranging from 0 (Definitely disagree) to 6 (Definitely agree).
Revised Child Anxiety and Depression Scale
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
The Revised Child Anxiety and Depression Scale (RCADS-25) is a self-report questionnaire that assesses symptoms of depression and anxiety in children and adolescents. This assessment captures symptoms related to generalized anxiety disorder (GAD), major depressive disorder (MDD), panic disorder, social phobia, separation anxiety disorder (SAD), and obsessive-compulsive disorder (OCD).
Saliva collection
Time frame: Baseline, 12 months, 24 months
Participants will be asked to provide a saliva sample to be used for genetic and epigenetic analyses. A saliva collection kit, such as that made by Oragene, will be used. Approximately 1.5 mL of saliva is provided when someone 'spits' into the collection tube. Cheek cells in saliva contain the DNA that will ultimately be extracted and processed.
The Short Warwick-Edinburgh Mental Well-being Scale
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) uses seven statements about thoughts and feelings to monitor mental wellbeing. The seven statements are positively worded with five response categories from 'none of the time' to 'all of the time'. Children and young people are asked to describe their experiences over the past two weeks.
The Social Communication Questionnaire
Time frame: Baseline
The Social Communication Questionnaire (40-item parent questionnaire), which is based on the Autism Diagnostic Interview-Revised, will be used to measure current and developmental social communication deficits. This parent-report questionnaire provides information regarding social communication and repetitive behaviours present currently and from early childhood. Total scores can range from a minimum of 0 to a maximum of 39, with higher scores indicating stronger social communication.
Social Responsiveness Scale (SRS) - Short Form
Time frame: Baseline, 12 months, 24 months, 30 months, 42 months
The Social Responsiveness Scale measures the severity of autism symptoms in a quantitative manner, both among children affected by symptoms that fall under the spectrum of autism as well as among children in the general population. Caregivers will complete the caregiver report school short form. Total scores can range from a minimum of 16 to a maximum of 64, with higher scores indicating lower social responsiveness.
Strengths and Weaknesses of Attention-Deficit/Hyperactivity (SWAN) Disorder Symptoms and Normal Behavior scale
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior scale assesses ADHD symptoms in the clinical and non-clinical population. It includes a set of 18 questions and a child's behavior is scored on a 7-point scale with 4 (average) reflecting a normal behavior for the child's age. The first 9 items are associated with inattentive ADHD and the next 9 items are associated with hyperactive/impulsive ADHD.
Suicidal Ideation Questionnaire-Junior
Time frame: Baseline, 3 months, 12 months, 24 months, 30 months, 42 months
The Suicidal Ideation Questionnaire-Junior (SIQ-JR) consists of 15 items and will be completed by all youth in this study. It is designed for students in Grades 7-9. This assessment assists in informing adults/professionals of their levels of distress and suicidal intent without self-injurious behaviour. The overall aim of this measure is to assess suicidal ideation and risk.
Toronto Obsessive-Compulsive Scale - Brief
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
The Toronto Obsessive-Compulsive Scale (TOCS) is a 21-item parent or self-report questionnaire that assesses symptoms pertaining to Obsessive-Compulsive traits among children or adolescents. Total scores can range from a minimum of -72 to a maximum of 72, with higher scores indicating the presence of more Obsessive-Compulsive traits.
Unmet Needs Questionnaire
Time frame: 12 months, 24 months, 36 months
The Unmet Needs Questionnaire measures the services participants are receiving and whether their needs are being met.
Youth Life Interference Scale
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
The Youth Life Interference Scale (YLIS) is an 11-item self-report measure assessing the impact of mental health symptoms on day-to-day functioning in the past two weeks. The measure was developed in-house for the TAY study. Its focus lies on functional impairment related to anxiety and depression for youth. Total scores can range from a minimum of 0 to a maximum of 36, with higher scores indicating greater functional impairment.
Kiddie Schedule for Affective Disorders and Schizophrenia
Time frame: Baseline, 24 months
The Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) is a widely used structured diagnostic interview that will be administered to participants in order to determine the presence of categorical mental health diagnoses. The K-SADS will be used for participants less than 18 years of age.
Prodromal Questionnaire - Brief
Time frame: Baseline
This is a self-report screening measure for psychosis risk syndromes. It records psychosis-like symptoms that would have occurred over the past month. For each item in the questionnaire that is endorsed, responses range in levels of distress or impairment from a scale of 1 (strongly disagree) to 5 (strongly agree).
Structured Interview for Prodromal Symptoms (SIPS) Negative/Disorganized Subscales
Time frame: Baseline
The Structured Interview for Prodromal Symptoms Negative/Disorganized Subscales is a diagnostic semi-structured interview used to assess the severity of symptoms and diagnose prodromal syndromes.
The Adolescent Alcohol and Drug Involvement Scale
Time frame: Baseline
The Adolescent Alcohol and Drug Involvement Scale (AADIS) Revised is a self-report measure of adolescent problematic substance abuse, and will be used to quantify frequency of past-year substance use (including cannabis use). This scale also provides a numerical score derived from items related to behaviors associated with problematic use. Total scores can range from a minimum of 0 to a maximum of 84, with higher scores indicating more frequent use of substances.
Assessment of Educational Attainment
Time frame: Baseline
Participants will be asked to fill in a self-report questionnaire measuring educational attainment which takes about 5 minutes to complete. The revised Educational Attainment Questionnaire will assess level of education, grades and accommodations or other support at school among other education-related items. Participants fill in the Educational Attainment Questionnaire at baseline. The Educational Attainment Questionnaire is composed of several items from the School Mental Health Survey that is part of the Ontario Child Health Study, a longstanding prospective study on the overall health of children in Ontario.
Social Responsiveness Scale - Long Form
Time frame: Baseline
Autism spectrum symptoms will be evaluated using the long form of the Social Responsiveness Scale (SRS-2), which is a validated brief measure of autism traits consisting of 65 items. Caregivers will complete the caregiver report school version. Total scores can range from a minimum of 65 to a maximum of 260, with higher scores indicating the presence of more autism traits.
Columbia Impairment Scale
Time frame: Baseline
The Columbia Impairment Scale (CIS) is a 13-item self and caregiver report scale which provides a global measure of impairment in 4 major areas of functioning: interpersonal relations (family and friends), broad psychopathological domains, job or school functioning, and use of leisure time. Total scores can range from a minimum of 0 to a maximum of 52, with higher scores indicating more global impairment.
Global Functioning: Social and Role Scales - Brief
Time frame: Baseline
The Global Functioning: Social and Role Scales assessment measures social and role functioning through a semi-structured interview. Total scores can range from a minimum of 1 to a maximum of 10, with higher scores indicating greater functioning.
Self-report World Health Organization - Disability Assessment Schedule
Time frame: Baseline
The Self-report World Health Organization - Disability Assessment Schedule is a 12-item generic assessment instrument for health and disability. This tool produces standardized disability levels and profiles directly linked at the level of the concepts to the International Classification of Functioning, Disability and Health (ICF), and covers six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. Total scores can range from a minimum of 0 to a maximum of 48, with higher scores indicating lower functioning.
Health and Social Service Utilization measure
Time frame: 6 months
Youth will be asked to self-report their mental health and other health and social service utilization using an adapted version of the Health and Social Service Utilization measure that has been previously used with this population, including in the current Longitudinal Youth in Transition Study at the Centre for Addiction and Mental Health (CAMH). Additional items are adapted from the Ontario Student Drug Use and Health Survey.
Transition Readiness Assessment Questionnaire
Time frame: 6 months
The Transition Readiness Assessment Questionnaire (TRAQ) will be used to assess the transition readiness of youth between the ages of 15 and 19 from youth to adult mental health services. Total scores can range from a minimum of 20 to a maximum of 100, with higher scores indicating greater transition readiness.
Internet Addiction Test
Time frame: Baseline
The Internet Addiction Test measures the presence and severity of problematic internet use across six addictive domains: Conflict, Mood Modification, Salience, Tolerance, Relapse, and Withdrawal.
Parent Child Internet Addiction Test
Time frame: Baseline
The Parent Child Internet Addiction Test measures the presence and severity of problematic internet use. This test is a 20-item measure asking the parent to indicate the frequency of behaviours in the child on a 6-point scale ranging from 'Does not apply' to 'Always'.
Leisure Time Questionnaire
Time frame: Baseline, 6 months
The Leisure Time Questionnaire is used to assess time spent in leisure activities.
MRI Scan
Time frame: Baseline
Youth participants enrolled in the deep phenotyping cohort will be asked to complete an MRI scan at their participating site for approximately 1 hour. Each scan will consist of high-quality T1-weighted, diffusion MRI (dMRI) and r-fMRI sequences that will be combined into a single neuroimaging output per participant.
Edinburgh Handedness Inventory - Brief
Time frame: Baseline
The Edinburgh Handedness Inventory (EHI) - Brief is a four-item questionnaire used to assess laterality. Youth are asked to report the dominance of the right or left hand in everyday activities. Scores range from -100 (indicating left preference) to 100 (indicating right preference).
The Snellen Chart
Time frame: Baseline
The Snellen Chart is an eye chart commonly used to assess visual acuity using eleven lines of block letters. Participants are asked to stand ten feet from the chart and to read the letters of each row aloud, beginning from the top row.
Toolbox Dimensional Change Card Sort Task
Time frame: Baseline
The Toolbox Dimensional Change Card Sort Task assesses cognitive flexibility. Youth are presented with two stimuli at the bottom of the screen and asked to sort a third stimulus presented in the middle of the screen to match one of the two stimuli at the bottom, by either colour or shape.
Toolbox Flanker Task
Time frame: Baseline
The Toolbox Flanker Task assesses attention and inhibitory control. Youth are presented with a target stimulus and two surrounding flanker stimuli, and are asked to indicate which direction the middle stimulus is facing (left or right); surrounding flanker stimuli may be facing in the same direction (congruent trials) or the opposite direction (incongruent trials).
Toolbox List Sorting Working Memory Test
Time frame: Baseline
The Toolbox List Sorting Working Memory Test assesses working memory sequencing skills. Youth are presented with animals and foods of assorted sizes both visually and auditorily, and asked to list the items presented from smallest to largest. This test is repeated using items from a single category, and items from two categories; in the latter, youth are requested to list items from one category and then the other.
Toolbox Oral Reading Recognition Task
Time frame: Baseline
The Toolbox Oral Reading Recognition Task assesses language exposure and reading skills. Youth are asked to pronounce visually presented letters or words.
Toolbox Pattern Comparison Processing Speed Test
Time frame: Baseline
The Toolbox Pattern Comparison Processing Speed Test assesses visual processing. Youth are asked to determine whether two visually presented pictures are the same.
Toolbox Picture Sequence Memory Test
Time frame: Baseline
The Toolbox Picture Sequence Memory Test assesses episodic memory. Youth are presented with 15 pictures demonstrating events and are asked to model those events as a series of actions using props.
Toolbox Picture Vocabulary Task
Time frame: Baseline
The Toolbox Picture Vocabulary Task assesses language and verbal intellect. Participants are auditorily presented with a word and asked to choose which of four visually presented pictures matches that word.
Rey Auditory Verbal Learning Test
Time frame: Baseline
The Rey Auditory Verbal Learning Test (RAVLT) assesses auditory learning and memory. Youth are asked to listen to and recall a list of 15 unrelated words over five learning trials. They are then presented with and asked to recall as many words from a second, distractor list of 15 words, and recall of the initial list is then assessed.
Wechsler Intelligence Test for Children-V Matrix Reasoning
Time frame: Baseline
This subtest of the Wechsler Intelligence Scale for Children assesses nonverbal reasoning, as well as visual intelligence, part-whole spatial reasoning, perceptual organization, attention to visual detail, and sequencing. Youth are presented with an incomplete array of visually presented stimuli, and asked to select one of four alternatives to complete the array. For participants aged 16 years or over, the Wechsler Adult Intelligence Scale-IV (WAIS-IV) version of this task will be administered.
Little Man Task
Time frame: Baseline
The Little Man Task (LMT) assesses visual-spatial processing, including mental rotation. Youth are asked to indicate which hand a figure is using to hold a briefcase after being presented with the figure in one of four positions.
Delay Discounting Task
Time frame: 6 months
Delay discounting can be defined as the depreciation of the value of a reward related to the time that it takes to be released. The task is an index of impulsive behaviour. Participants play a game in which they make a choice between an immediate small reward and a delayed larger reward.
Emotional Stroop Task
Time frame: 6 months
The Emotional Stroop Task is a modified version of the traditional Stroop task in which participants are required to name the ink color of words with emotional or neutral valence. This task is commonly used to measure the attentional biases toward emotional stimuli typically observed in humans.
Penn Emotion Differentiation Task
Time frame: 6 months
The Penn Emotion Differentiation Task measures the social cognition domain of emotion identification - the ability to decode and correctly identify facial expressions of emotion. Youth are shown 40 faces and must determine whether the emotion expressed is happiness, sadness, anger, fear, or none at all.
The Awareness of Social Inference Test (TASIT) - Short Version
Time frame: 6 months
The Awareness of Social Inference Test (TASIT) - Short Version measures social cognition using videos of naturalistic everyday conversations in which two actors interact. It has established ecological validity, reliability and construct validity. Alternate forms are available for re-testing.
Parental Bonding Instrument
Time frame: Baseline
The Parental Bonding Instrument (PBI) was designed to measure the contribution of parental behavior to the development of appropriate bonds between parents and children. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Personality Inventory for DSM-5 Faceted Brief Form
Time frame: 6 months
The Personality Inventory for DSM-5 Faceted Brief Form (PID-5-FBF) will be used to examine maladaptive personality traits. The PID-5-FBF is a 100-item self-rated personality trait assessment scale for adolescents and adults. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Competitive Sports Questionnaire
Time frame: 6 months
This is an 8-item questionnaire originally developed for the TAY study.
International Physical Activity Questionnaire
Time frame: 6 months
This measure is a questionnaire measuring physical activities in the last 7 days.
Pain Questionnaire
Time frame: 6 months
This measure assesses types of pain and frequency, and the impact of pain on 5-point Likert scales. For each pain item the participant needs to indicate if pain can be explained by a physical accident or diagnosed medical condition.
Puberty Development Scale
Time frame: 6 months
This scale contains five items, with the last two items being different for males and females. It assesses the presence of developmental changes associated with puberty. Total scores can range from a minimum of 5 to a maximum of 20, with higher scores indicating the presence of more developmental changes.
Social Media Addiction Questionnaire
Time frame: Baseline
The Social Media Addiction Questionnaire (SMAQ) is comprised of questions adapted from the Ontario Student Drug Use and Health Survey. These questions will be used to collect information on screen time use, problematic social media use and video game use, respectively, as reported by the youth participant. Total scores can range from a minimum of 6 to a maximum of 36, with higher scores indicating more problematic use of social media.
Acculturation Questionnaire
Time frame: 6 months
The Acculturation Questionnaire will be used to measure speaking and reading skills in English and language preference. This measure includes multiple subscale scores assessing different domains, with scores interpreted separately by subscale.
Mexican American Cultural Values Scale
Time frame: 6 months
The Mexican American Cultural Values Scale (50 items) is used to assess family values of individuals from diverse cultural backgrounds. Total scores can range from a minimum of 50 to a maximum of 250, with higher scores indicating less adherence to the outlined cultural values.
Multigroup Ethnic Identity-Revised
Time frame: 6 months
The Multigroup Ethnic Identity-Revised will be used to measure cultural affiliation. This measure contains 6 items that can be rated on a five-point scale from strongly disagree to strongly agree. Total scores can range from a minimum of 6 to a maximum of 24, with higher scores indicating stronger cultural affiliation.
Vancouver Index of Acculturation - Short
Time frame: 6 months
The Vancouver Index of Acculturation - Short will be used to measure acculturation with 20 items that can be rated from disagree to agree on a 9-point scale. Total scores can range from a minimum of 10 to a maximum of 90, with higher scores indicating greater acculturation.
Parental Monitoring
Time frame: 6 months
Family and social influences including parental monitoring and interactions with family members will be measured using the Parental Monitoring questionnaire. Total scores can range from a minimum of 5 to a maximum of 25, with higher scores indicating higher parental involvement.
Prosocial Scale from the Strengths and Difficulties Questionnaire
Time frame: 6 months
Family and social influences including prosocial behaviors and interactions with family members will be measured using the Prosocial Scale. Total scores can range from a minimum of 0 to a maximum of 10, with higher scores indicating more prosocial behaviors.
Conflict Behavior Questionnaire
Time frame: 6 months
Family and social influences including interactions with family members will be measured using the Conflict Behavior Questionnaire. Total scores can range from a minimum of 0 to a maximum of 20, with higher scores indicating the presence of more conflict-related behaviors.
Gender Dysphoria Questionnaire for Adolescents and Adult
Time frame: 6 months
In addition to self-reported gender obtained using the demographic protocol, gender expression will be measured using the Gender Dysphoria Questionnaire for Adolescents and Adults. Total scores can range from a minimum of 27 to a maximum of 135, with higher scores indicating greater satisfaction and less gender-related distress.
Personal Attributes Questionnaire
Time frame: 6 months
In addition to self-reported gender obtained using the demographic protocol, gender identity variability will be measured using the Personal Attributes Questionnaire. Total scores can range from a minimum of 0 to a maximum of 96, with higher scores indicating stronger self-perceptions of gender attributes.
Adverse Life Events Scale
Time frame: 6 months
Life events and current life stress will be assessed in all participants below age 18 using The Adverse Life Events Scale. Total scores can range from a minimum of 0 to a maximum of 25, with higher scores indicating more adverse life events and/or related stress.
Childhood Trauma Questionnaire - Short Form
Time frame: 6 months
All participants will be administered the Childhood Trauma Questionnaire - Short Form to identify traumatic childhood conditions. Total scores can range from a minimum of 28 to a maximum of 125, with higher scores indicating greater exposure to traumatic childhood conditions.
Connor-Davidson Resilience Scale
Time frame: 6 months
Individual resilience in the face of stress will be measured using a brief, two-item version of the Connor-Davidson Resilience Scale. Total scores can range from a minimum of 0 to a maximum of 8, with higher scores indicating higher resilience.
Everyday Discrimination Scale
Time frame: 6 months
Lifetime discriminatory experiences will be assessed in all participants using a Canadian adaptation of the Everyday Discrimination Scale. Total scores can range from a minimum of 5 to a maximum of 25, with higher scores indicating greater discriminatory experiences.
Life Events Checklist
Time frame: 6 months
The Life Events Checklist (LEC) is designed to screen for potentially traumatic experiences that may contribute to psychological distress. Participants aged 18 and above will be administered the Life Events Checklist.
Inventory for School Risk and Protective Factors
Time frame: 6 months
All participants' school environments will be characterized using the Inventory for School Risk and Protective Factors measure from the ABCD study. Total scores can range from a minimum of 6 to a maximum of 24, with higher scores indicating greater protective factors.
Neighbourhood Safety and Crime Scale
Time frame: 6 months
In the proximal social environment, neighbourhood safety will be measured using a three-item Neighbourhood Safety and Crime Scale. Total scores can range from a minimum of 3 to a maximum of 15, with higher scores indicating lower perceived neighbourhood safety.
3-Digit Postal Codes
Time frame: Baseline
3-digit postal codes of participants (collected as part of routine demographic data) will be used to obtain census-based neighbourhood-level marginalization data; this will allow each participant's neighbourhood to be characterized by the level of social and economic marginalization as well as ethnic concentration. At the time of cohort entry, the first 3 digits of each participant's postal code are collected based on the participant's residential address. Any change in a participant's residential address will also be recorded during assessment periods during the study to account for changes in exposure to socio-environmental factors.
Parent General Behaviour Inventory-10 Mania
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
Caregivers will complete the Parent General Behaviour Inventory-10 Mania, which measures the presence and severity of mania. Total scores can range from a minimum of 0 to a maximum of 30, with higher scores indicating greater presence and severity of mania.
Video Game Addiction Questionnaire
Time frame: Baseline
The Video Game Addiction Questionnaire (VGAQ) is comprised of questions adapted from the Ontario Student Drug Use and Health Survey. These questions will be used to collect information on screen time use, problematic social media use and video game use, respectively, as reported by the youth participant. Total scores can range from a minimum of 6 to a maximum of 36, with higher scores indicating more problematic use of video games.
Student Adaptation to College Questionnaire
Time frame: Baseline
The Student Adaptation to College Questionnaire (SACQ) is a self-report questionnaire measuring educational attainment. Participants attending post-secondary school will also be asked to complete the SACQ. Total scores can range from a minimum of 67 to a maximum of 603, with higher scores indicating better overall adjustment to college life.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 33159037Zabihi M, Floris DL, Kia SM, Wolfers T, Tillmann J, Arenas AL, Moessnang C, Banaschewski T, Holt R, Baron-Cohen S, Loth E, Charman T, Bourgeron T, Murphy D, Ecker C, Buitelaar JK, Beckmann CF, Marquand A; EU-AIMS LEAP Group. Fractionating autism based on neuroanatomical normative modeling. Transl Psychiatry. 2020 Nov 6;10(1):384. doi: 10.1038/s41398-020-01057-0.
- Background: PubMed 18452343Youngstrom EA, Frazier TW, Demeter C, Calabrese JR, Findling RL. Developing a 10-item mania scale from the Parent General Behavior Inventory for children and adolescents. J Clin Psychiatry. 2008 May;69(5):831-9. doi: 10.4088/jcp.v69n0517.
- BackgroundYoung, K. S. (1998). Internet Addiction: The Emergence of a New Clinical Disorder. CyberPsychology & Behavior, 1(3), 237-244. https://doi.org/10.1089/cpb.1998.1.237
- Background: PubMed 24976354Wood DL, Sawicki GS, Miller MD, Smotherman C, Lukens-Bull K, Livingood WC, Ferris M, Kraemer DF. The Transition Readiness Assessment Questionnaire (TRAQ): its factor structure, reliability, and validity. Acad Pediatr. 2014 Jul-Aug;14(4):415-22. doi: 10.1016/j.acap.2014.03.008.
- Background: PubMed 33638594Wolfers T, Rokicki J, Alnaes D, Berthet P, Agartz I, Kia SM, Kaufmann T, Zabihi M, Moberget T, Melle I, Beckmann CF, Andreassen OA, Marquand AF, Westlye LT. Replicating extensive brain structural heterogeneity in individuals with schizophrenia and bipolar disorder. Hum Brain Mapp. 2021 Jun 1;42(8):2546-2555. doi: 10.1002/hbm.25386. Epub 2021 Feb 27.
- Background: PubMed 30782224Wolfers T, Beckmann CF, Hoogman M, Buitelaar JK, Franke B, Marquand AF. Individual differences v. the average patient: mapping the heterogeneity in ADHD using normative models. Psychol Med. 2020 Jan;50(2):314-323. doi: 10.1017/S0033291719000084. Epub 2019 Feb 14.
- BackgroundWechsler Intelligence Scale for Children | Fifth Edition. (n.d.). Retrieved April 17, 2024, from https://www.pearsonassessments.com/store/usassessments/en/Store/Professional-Assessments/Cognition-%26-Neuro/Wechsler-Intelligence-Scale-for-Children-%7C-Fifth-Edition-/p/100000771.html
- Background: PubMed 23659650Veale JF. Edinburgh Handedness Inventory - Short Form: a revised version based on confirmatory factor analysis. Laterality. 2014;19(2):164-77. doi: 10.1080/1357650X.2013.783045. Epub 2013 May 10.
- Background: PubMed 37580524Uhlhaas PJ, Davey CG, Mehta UM, Shah J, Torous J, Allen NB, Avenevoli S, Bella-Awusah T, Chanen A, Chen EYH, Correll CU, Do KQ, Fisher HL, Frangou S, Hickie IB, Keshavan MS, Konrad K, Lee FS, Liu CH, Luna B, McGorry PD, Meyer-Lindenberg A, Nordentoft M, Ongur D, Patton GC, Paus T, Reininghaus U, Sawa A, Schoenbaum M, Schumann G, Srihari VH, Susser E, Verma SK, Woo TW, Yang LH, Yung AR, Wood SJ. Towards a youth mental health paradigm: a perspective and roadmap. Mol Psychiatry. 2023 Aug;28(8):3171-3181. doi: 10.1038/s41380-023-02202-z. Epub 2023 Aug 14.
- Background: PubMed 9808931Tiet QQ, Bird HR, Davies M, Hoven C, Cohen P, Jensen PS, Goodman S. Adverse life events and resilience. J Am Acad Child Adolesc Psychiatry. 1998 Nov;37(11):1191-200. doi: 10.1097/00004583-199811000-00020.
- BackgroundThe Ontario Student Drug Use and Mental Health Survey (OSDUHS). (n.d.). CAMH. Retrieved May 1, 2024, from https://www.camh.ca/en/science-and-research/institutes-and-centres/institute-for-mental-health-policy-research/ontario-student-drug-use-and-health-survey---osduhs
- BackgroundThe Hospital for Sick Children Research Ethics Board Blood Sampling Guidelines. (n.d.). Retrieved March 10, 2025, from https://www.sickkids.ca/siteassets/research/reb/research-ethics-guidelines/sickkids-reb-blood-volume-guidelines-2020-2021.pdf
- Individual participant dataSharing planned: Yes. De-identified data from this project may be used for future research by internal project collaborators. De-identified and anonymized data from this research study will be deposited to site specific database repositories for future use. Data will be shared with third-parties for secondary use via the Brain-CODE Platform. Third-parties will own the derived outputs such as new data and analyses (the Work Product) that result from their use of the data. Ontario Brain Institute - Brain-CODE Participation Agreement: The Centre for Ontario Data Exploration (Brain-CODE), is an informatics platform established by the Ontario Brain Institute to facilitate and expedite the investigation, discovery, or scientific query within and/or across several health conditions. All participating sites in CALM, including CAMH have signed Brain-CODE Participation Agreements with OBI agreeing to contribute data to Brain-CODE.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise Gallagher, MB, BCh, PhD principal investigator
Centre for Addiction and Mental Health
Paul Arnold, MD, PhD principal investigator
University of Calgary
Gary Goldfield, PhD, C. Psych. principal investigator
The Children's Hospital of Eastern Ontario Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Mental Health Conditions and Child Mental Health, run by Centre for Addiction and Mental Health at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Gallagher, MD, PhD (416-535-8501 ext. 33566, louise.gallagher@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Assessment for the Health Spectrum (time frame: Baseline and 24 months). The study lists 96 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07699159, which also lists 104 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.