ICP1CARIBOUNCT03428555
Integrated Care Pathway for Youth Depression
A study testing Integrated Care Pathway and Treatment As Usual in people with ICP1 and Depression, run by Centre for Addiction and Mental Health at 2 sites in Canada.
Trial summary
Major Depressive Disorder in adolescence is prevalent and debilitating. Our group aims to improve treatment response through the use of an Integrated Care Pathway (ICP) based on a high quality Clinical Practice Guideline and measurement-based care (MBC; where periodic symptom scale scores are used to make treatment… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- ICP1, Depression, Adolescent Behavior
- What is being tested?
- Integrated Care Pathway and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- 29 Mar 2018to 21 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Psychiatrist's impression is that depression is a primary psychiatric. concern
- 14-18 years old.
- DSM-5 criteria for Major Depressive Disorder or Persistent Depressive Disorder as per the Diagnostic Interview for Affective Symptoms for Children (DIAS-C19).
- Speak, read and write English at a grade 6 level.
Who cannot join
- Threshold psychotic symptoms.
- Bipolar disorder.
- Moderate-to-severe substance use disorder.
- Autistic spectrum disorder or intellectual disability.
- Eating disorder.
- Suicide-related behaviours requiring acute intervention.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4Y 3M5
Amy Cheung, MD, 4164804073, amy.cheung@sunnybrook.ca
Michelle Li, BA, 4164804073, michelle.li@sunnybrook.ca
- Recruiting
The Center for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Darren B Courtney, MD, 416-535-8501 ext. 30539, darren.courtney@camh.ca
Susan Dickens, MA, 416-535-8501, susan.dickens@camh.ca
About this study
Official title: Is an Integrated Care Pathway for Adolescents With Depression More Effective Than Treatment as Usual? A Controlled Clinical Trial
Major Depressive Disorder in adolescence is prevalent and debilitating. Our group aims to improve treatment response through the use of an Integrated Care Pathway (ICP) based on a high quality Clinical Practice Guideline and measurement-based care (MBC; where periodic symptom scale scores are used to make treatment decisions). We propose a controlled clinical trial comparing ICP to treatment-as-usual (TAU) across two sites.
Read the detailed description
Background: There is a gap between what is known from the evidence about the treatment of adolescent depression and what is practiced. Moreover, while there is evidence that measurement-based care can improve outcomes for adults with various mental health conditions, there is limited information on this framework in adolescent depression.
Objective: Our study aims to enhance the implementation of evidence-based care (using the NICE Clinical Practice Guidelines as a template) combined wtih measurement-based care through the use of an Integrated Care Pathway (ICP) in adolescents with depression.
Hypothesis: As this is a pilot study, our hypotheses centre around feasibility. We hypothesize that: (1) we will recruit at least 30 participants to the ICP treatment arm and 30 participants at the "treatment-as-usual" arm at a different site (2) that baseline measures will be fully completed by 95% of adolescents recruited, (3) that baseline measures will take 2 hours to complete for adolescents and 1 hour to complete for caregivers, (4) that a mean of 90% of the key aspects of the treatment protocol are followed in the ICP group (5) that 80% of participants recruited will complete measures at the end of the 20-week interval and that (6) 90% of the youth, caregivers and clinicians who partake int eh study will attend a focus group to provide qualitative feedback on their experience.
Design: This is a non-randomized controlled clinical trial. Randomizing at the individual level is not possible - the intervention is implemented at the clinic level; so the effect of the intervention on one youth within a clinic would influence the care of other youth at the clinic.
Sampling: Participants are recruited from psychiatric clinics at 2 sites. Each site will recruit to their respective treatment arm.
- Conditions
- ICP1, Depression, Adolescent Behavior
- Being tested
- Integrated Care Pathway, Treatment As Usual
- Medical subject headings
- Depression, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Care PathwayBehavioural
The intervention is a integrated care pathway based on the NICE Clinical Practice Guidelines and measurement-based care in the form of a flow chart. Each decision point on the pathway is guided by results of self-report measures for depression (the Mood and Feelings Questionnaire), functional impairment (Columbia Impairment Scales) and family functioning (the McMaster Family Assessment Device). The results of these scales and protocol recommendations are fed back to the patients, families and clinicians in order to make further treatment decisions
Treatment As UsualBehavioural
Treatment As Usual represents what clinicians would typically do when presented with an adolescent with depression. There is no algorithm provided to guide clinical decision-making and no systematic measurement-based care.
| Study group | Role | What they receive |
|---|---|---|
| Integrate Care Pathway | Experimental | The intervention is an Integrated Care Pathway with 3 key components.
1. Clinical Practice Guidelines (CPG) recommendations: The initial template of the treatment protocol was based on the NICE CPGs for Depression in Children and Young People.
2. Provider engagement: The clinicians at CAMH reviewed the template and collaboratively developed a flow chart defining the treatment protocol.
3. Measurement-based care: Feedback measures are taken every four weeks and the results are provided to the clinician, patient and family to inform treatment decisions. The feedback measures are the Mood and Feelings Questionnaire, the Columbia Impairment Scale (CIS) and the General Functioning Domain of the McMaster Family Assessment Device (MFAD). Receives: Behavioral: Integrated Care Pathway |
| Treatment As Usual | Active comparator | Treatment As Usual : Participants at SHSC will receive treatment at could include a psychiatric evaluation, possible medication management and various types of psychotherapy, including cognitive-behavioural therapy, interpersonal psychotherapy, psychodynamic psychotherapy and family therapy. There is no structured protocol and no systematic Measurement Based Care. A research assistant will record the interventions received in either group via chart review. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Childhood Depression Rating Scale-Revised scores
The CDRS-R is a 17-item measure rated by an evaluator after a semi-structured interview with the adolescent relating to symptoms of depression over the past 2 weeks. Scores range from 0 to 100 with a score of over 55 interpreted as a moderate to severe rating. Lower values represent a better outcome.
Measured: 20 weeks
Secondary outcomes (2)
Change in WHO Disability Assessment Schedule 2.0 for Children And Youth
Change in function as reported by participant The sum of scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations. Lower values represent a decrease in their subjective depression rating over the previous 2 weeks.
Measured: 20 weeks
Change in Childhood Behaviour Checklist
Change in overall psychopathology as reported by caregiver.Total scores may be computed for Social Competence, Behavior Problems, Internalizing Problems, and Externalizing Problems, plus scores for each of the 8 syndrome scales. Raw scores are converted to age-standardized scores (T-Scores). T scores less than 67 are considered in the normal range, T scores ranging from 67-70 are considered to be borderline clinical, and T scores above 70 are in the clinical range.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start29 Mar 2018
- Primary completion29 Aug 2019 (estimated)
- Study completion21 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICP1Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Arm (n=30 over 17 months at, CAMH): The intervention is an integrated care pathway and Comparison Arm- Treatment As Usual (n=30 over 17 months at SHSC):
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Principal investigator, Darren Courtney, Centre for Addiction and Mental Health
- Investigators
- Peter Szatmari, MD, Study director, The Center for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428555
- Sponsor's protocol ID
- 079/2017
- Acronym
- CARIBOU
- Status last verified
- Aug 2018
- First submitted
- 2 Feb 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Courtney DB, Cheung A, Henderson J, Bennett K, Wang W, Chen S, Battaglia M, Strauss J, Mitchell R, Wang K, Relihan J, Prebeg M, Darnay K, Szatmari P. CARIBOU-1: A pilot controlled trial of an Integrated Care Pathway for the treatment of depression in adolescents. JCPP Adv. 2022 May 27;2(2):e12083. doi: 10.1002/jcv2.12083. eCollection 2022 Jun.
PubMed 37431464
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is an Integrated Care Pathway for Adolescents With Depression More Effective Than Treatment as Usual? A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03428555
- Acronym / sponsor ID
- CARIBOU / 079/2017
- Conditions
- ICP1, Depression, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 29 Aug 2019 (estimated)
- Study completion
- 21 Feb 2020 (estimated)
- First posted
- 9 Feb 2018 (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.
Major Depressive Disorder in adolescence is prevalent and debilitating. Our group aims to improve treatment response through the use of an Integrated Care Pathway (ICP) based on a high quality Clinical Practice Guideline and measurement-based care (MBC; where periodic symptom scale scores are used to make treatment decisions). We propose a controlled clinical trial comparing ICP to treatment-as-usual (TAU) across two sites.
Detailed description
Background: There is a gap between what is known from the evidence about the treatment of adolescent depression and what is practiced. Moreover, while there is evidence that measurement-based care can improve outcomes for adults with various mental health conditions, there is limited information on this framework in adolescent depression.
Objective: Our study aims to enhance the implementation of evidence-based care (using the NICE Clinical Practice Guidelines as a template) combined wtih measurement-based care through the use of an Integrated Care Pathway (ICP) in adolescents with depression.
Hypothesis: As this is a pilot study, our hypotheses centre around feasibility. We hypothesize that: (1) we will recruit at least 30 participants to the ICP treatment arm and 30 participants at the "treatment-as-usual" arm at a different site (2) that baseline measures will be fully completed by 95% of adolescents recruited, (3) that baseline measures will take 2 hours to complete for adolescents and 1 hour to complete for caregivers, (4) that a mean of 90% of the key aspects of the treatment protocol are followed in the ICP group (5) that 80% of participants recruited will complete measures at the end of the 20-week interval and that (6) 90% of the youth, caregivers and clinicians who partake int eh study will attend a focus group to provide qualitative feedback on their experience.
Design: This is a non-randomized controlled clinical trial. Randomizing at the individual level is not possible - the intervention is implemented at the clinic level; so the effect of the intervention on one youth within a clinic would influence the care of other youth at the clinic.
Sampling: Participants are recruited from psychiatric clinics at 2 sites. Each site will recruit to their respective treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention Arm (n=30 over 17 months at, CAMH): The intervention is an integrated care pathway and Comparison Arm- Treatment As Usual (n=30 over 17 months at SHSC):
| Arm | Type | Receives |
|---|---|---|
| Integrate Care Pathway | Experimental | Behavioral: Integrated Care PathwayThe intervention is an Integrated Care Pathway with 3 key components. 1. Clinical Practice Guidelines (CPG) recommendations: The initial template of the treatment protocol was based on the NICE CPGs for Depression in Children and Young People. 2. Provider engagement: The clinicians at CAMH reviewed the template and collaboratively developed a flow chart defining the treatment protocol. 3. Measurement-based care: Feedback measures are taken every four weeks and the results are provided to the clinician, patient and family to inform treatment decisions. The feedback measures are the Mood and Feelings Questionnaire, the Columbia Impairment Scale (CIS) and the General Functioning Domain of the McMaster Family Assessment Device (MFAD). |
| Treatment As Usual | Active comparator | Behavioral: Treatment As UsualTreatment As Usual : Participants at SHSC will receive treatment at could include a psychiatric evaluation, possible medication management and various types of psychotherapy, including cognitive-behavioural therapy, interpersonal psychotherapy, psychodynamic psychotherapy and family therapy. There is no structured protocol and no systematic Measurement Based Care. A research assistant will record the interventions received in either group via chart review. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Psychiatrist's impression is that depression is a primary psychiatric. concern
- 14-18 years old.
- DSM-5 criteria for Major Depressive Disorder or Persistent Depressive Disorder as per the Diagnostic Interview for Affective Symptoms for Children (DIAS-C19).
- Speak, read and write English at a grade 6 level.
Key exclusion criteria (6 listed)
- Threshold psychotic symptoms.
- Bipolar disorder.
- Moderate-to-severe substance use disorder.
- Autistic spectrum disorder or intellectual disability.
- Eating disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Care PathwayThe intervention is a integrated care pathway based on the NICE Clinical Practice Guidelines and measurement-based care in the form of a flow chart. Each decision point on the pathway is guided by results of self-report measures for depression (the Mood and Feelings Questionnaire), functional impairment (Columbia Impairment Scales) and family functioning (the McMaster Family Assessment Device). The results of these scales and protocol recommendations are fed back to the patients, families and clinicians in order to make further treatment decisions | Behavioural | Integrate Care Pathway |
| Treatment As UsualTreatment As Usual represents what clinicians would typically do when presented with an adolescent with depression. There is no algorithm provided to guide clinical decision-making and no systematic measurement-based care. | Behavioural | Treatment As Usual |
Primary outcome
Change in Childhood Depression Rating Scale-Revised scores
Time frame: 20 weeks
The CDRS-R is a 17-item measure rated by an evaluator after a semi-structured interview with the adolescent relating to symptoms of depression over the past 2 weeks. Scores range from 0 to 100 with a score of over 55 interpreted as a moderate to severe rating. Lower values represent a better outcome.
2 secondary outcomes
Change in WHO Disability Assessment Schedule 2.0 for Children And Youth
Time frame: 20 weeks
Change in Childhood Behaviour Checklist
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 37431464Courtney DB, Cheung A, Henderson J, Bennett K, Wang W, Chen S, Battaglia M, Strauss J, Mitchell R, Wang K, Relihan J, Prebeg M, Darnay K, Szatmari P. CARIBOU-1: A pilot controlled trial of an Integrated Care Pathway for the treatment of depression in adolescents. JCPP Adv. 2022 May 27;2(2):e12083. doi: 10.1002/jcv2.12083. eCollection 2022 Jun.
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. This study is not recruiting at the moment.
Peter Szatmari, MD study director
The Center for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Care Pathway and Treatment As Usual in people with ICP1 and Depression, run by Centre for Addiction and Mental Health at 2 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darren B Courtney, MD (416-535-8501 ext. 30539, darren.courtney@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Childhood Depression Rating Scale-Revised scores (time frame: 20 weeks). 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 NCT03428555, which also lists 1 linked publication.
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 9 Aug 2018.