Major Depressive DisorderCARIBOU-2NCT05142683
Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial
A study testing Treatment As Usual and CARIBOU-2 in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This is a quasi-experimental, multi-site cluster controlled clinical trial design with two intervention arms--Treatment As Usual (TAU) and an Integrated Care Pathway (ICP). Eligible participants are between the ages of 13 and 18, who present to community mental health agencies with depressive symptoms as the primary… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Treatment As Usual and CARIBOU-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 30 Sep 2027
- Phase
- Interventional
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youth is aged 13 to 18 years, inclusive.
- Youth and/or their caregiver is expressing that 'depression" (or some synonym) is a concern.
- Clinician agrees that depressive symptoms are a treatment target.
- Mood and Feelings Questionnaire score is ≥22 at two sequential visits (screening and baseline assessment).
- Youth must be new to the site (in past 3 months) or have a period of no treatment for 3 months
Who cannot join
- Known or highly suspected presentations of psychotic symptoms that are persistent, affect functioning, and have observable effects on behaviour.
- Severe substance use disorder, bipolar disorder, autism spectrum disorder or intellectual disability, severe eating disorder, imminent risk of suicide requiring hospitalization as per judgment of the assessing clinician.
- Inability to provide informed consent to the study for any reason
- Youth currently in Day Treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eva Gonzalez Villanueva, Research Coordinator, MPH, MSSW, RSW contact
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario
Katye Stevens, Research Operations Manager, 800-463-2338 ext. 34914, Katye.Stevens@camh.ca
Eva Gonzalez Villanueva, Research Coordinator, MPH, MSSW, RSW, 800-463-2338 ext. 34914, eva.gonzalezvillanueva@camh.ca
About this study
Official title: Effectiveness of an Integrated Care Pathway for Adolescent Depression: A Quasi-experimental, Multi-site, Cluster Controlled Trial
This is a quasi-experimental, multi-site cluster controlled clinical trial design with two intervention arms--Treatment As Usual (TAU) and an Integrated Care Pathway (ICP). Eligible participants are between the ages of 13 and 18, who present to community mental health agencies with depressive symptoms as the primary concern. The primary clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. The secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining implementation outcomes such as feasibility, fidelity cost and acceptability.
Read the detailed description
Background: Depression is the leading cause of disability in adolescents and a potent risk factor for suicide. Evidence-based treatments are available; however, many clinics do not provide guidelines-based treatments. Integrated Care Pathways (ICPs) are treatment algorithms based on the highest quality practice guidelines intended to facilitate the delivery of evidence-based treatment at the clinic level. Our group has already tested the feasibility of ICP for adolescent depression at an academic setting. There is still uncertainty regarding whether ICPs lead to improved outcomes in depression in adolescents in community settings relative to typical care.
Objective: The current study aim is to test the effectiveness of an ICP for depression in adolescence, called the CARIBOU-2 intervention, versus treatment-as-usual (TAU) in community settings. This study will also examine important implementation outcomes.
Method: The primary participants are adolescents (Up to N=150), between the ages of 13 to 18 with depressive symptoms, presenting to one of the participating sites. Through a quasi-experimental, multi-site cluster controlled clinical trial design, sites began in the TAU condition and transitioned to the ICP condition once local enrollment to TAU has reached up to 25 participants. The primary clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. Secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining the following implementation outcomes: feasibility, fidelity cost and acceptability. Implementation will also be assessed at three additional sites through a light-touch evaluation conducted several months after training and implementation of the pathway, focusing on clinicians' perspectives and experiences.
Statistical Analyses:
Descriptive data analysis will be first conducted to examine distribution of collected measures and evaluate whether there are significant differences across arms of assigned sites. Generalized linear mixed-effects model will be the primary analytic tool for evaluating whether the CARIBOU-2 intervention is more effective than TAU for adolescents with depression presenting to care with regards to improvement of depressive symptoms, self-reported functioning, caregiver-reported internalizing psychopathology, and suicidal ideation and behaviours. Time, treatment assignment and their interactions will serve as the primary predictors for the analyses. As an example, if we let Y_ijt to denote a continuous outcome of the j-th participant of the i-th site measured at time t, a linear model for Y_ijt will look like the following:
Y_ijt=β_0+〖b_(0,ij)+b_(1,i)+β〗_1 t+β_2 〖Group〗_(i,t)+β_3 Group_it*t+〖β_4 X_ijt+ϵ〗_ijt
of which 〖Group〗_(i,t) denotes the treatment assignment of the i-th site at time t, X_ijt, additional covariates, b_(0,ij) and b_(1,i), random effects at individual and site levels respectively, ϵ_( ijt), unexplained random error, and β's, regression coefficients. For sensitivity analyses, we will explore the use of the piecewise model to model the time trend differently. We will adopt the intention-to-treat approach in general and use multiple imputation methods as the primary missing data strategy. In our pilot study, we have collected ~85% of expected longitudinal data points on the MFQ (primary clinical outcome), adjusting for attrition. Sensitivity analysis will be conducted to evaluate the impact of non-random missing and robust regression method will be used instead when the impact is high. SAS 9.4 will be our go-to software package for this project.
Relevance: Should our results be consistent with our hypotheses, systematic implementation of the CARIBOU-2 intervention to other community mental health agencies and hospitals would be indicated.
- Conditions
- Major Depressive Disorder
- Being tested
- Treatment As Usual, CARIBOU-2
- Keywords
- Adolescents, Integrated Care Pathway, Depression, Measurement Based Care, Implementation
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment As UsualOther
Various typical interventions for adolescents with depression.
CARIBOU-2Other
Integrated Care Pathway intervention for adolescents with depression.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | Active comparator | Study involvement for all sites will begin in the TAU condition, which is the typical treatment at the participating community mental health agency. A range of treatments observed in our previous survey of sites will be on offer in these agencies, depending on the preferences and context of the local agency. In typical TAU in community mental health agencies, depressive symptoms and function are not systematically monitored via standardized rating scales. TAU may or may not include referral to psychotherapy and/or parent support. There are no prompts to prescribe specific medications, and/or internal and external referrals to treatment and other services, guided by local service standards. Receives: Other: Treatment As Usual |
| CARIBOU-2 | Experimental | After the CARIBOU-1 pilot study, the Principal Investigator revised the ICP to render it more applicable to community settings as well as offer a second-line psychotherapy ("Brief Psychosocial Intervention") for youth who do not engage with, or respond to, cognitive-behavioural therapy. The revised version is called the CARIBOU-2 intervention. The current iteration of the pathway involves a series of steps: (1) structured assessment, including safety assessment; (2) education on depression, sleep, exercise, and diet; (3) psychotherapy (with 1st line Cognitive Behavioural Therapy, 2nd line "Brief Psychosocial Intervention"); (4) a caregiver structured support group; (5) medication options (1st line fluoxetine, 2nd line sertraline); (6) "team reviews" every four weeks, (meeting with the youth and involved clinicians to review measures and discuss treatment changes); and, (7) discharge and follow-up planning. Receives: Other: CARIBOU-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mood and Feelings Questionnaire (MFQ) child, long version
The MFQ is a 33-item self-report measure for youth regarding depressive symptoms experienced over the prior 2 weeks. It was specifically recommended in the NICE guideline, given its strong psychometric properties; namely, it has high discriminatory ability in adolescents, good internal consistency (α=0.92-0.94) and good test-retest reliability (Pearson's r=0.78). It has also been used in a large trial of psychotherapy with adolescents where it was sensitive to change.
Measured: Change from baseline to 24 weeks
Secondary outcomes (11)
The Child Behaviour Checklist (CBCL) - Parent Report Form
A 118-item caregiver-rated measure assessing the youth's behaviour and general psychopathology. It is a widely used measure with known population norms. One-week test-retest reliability was found to be 0.80-0.94. Internal consistency is reported to be high; inter-rater reliability (e.g., between two parents) was found to be moderate to high (reference needed). All subscales will be used at baseline to describe general psychopathology. The internalizing broadband scale of the CBCL (i.e. anxious-depressed, depressed-withdrawn, and somatic subscales combined) will be measured longitudinally to get an impression of how the caregiver is observing any changes in mood or anxiety with treatment.
Measured: Baseline to 24-weeks
Columbia Suicide Severity Rating Scale
This measure contains items related self-injurious thoughts and behaviours. RAs rate 3 subscales: Suicidal Ideation Severity, Suicidal Behaviour (which includes suicide attempts and an item for non-suicidal self-injury that is recorded as distinct from suicidal behaviour), and Lethality.
Measured: Change from baseline to 24 weeks
Depression Rating Scale
This is an RA-rated 13-item subscale found in the Kiddie Schedule for Affective Disorders and Schizophrenia-Lifetime version used to assess for DSM-5 criteria of Major Depressive Disorder.
Measured: Change from baseline to 24 weeks
Youth Quality of Life Scale Research Version
This is a 41 item self-report scale measuring the broad array of constructs including sense of self-worth, quality of relationships, sense of agency and life satisfaction.
Measured: Change from baseline to 24 weeks
Clinical Global Impression Scale - both the Improvement Subscale (CGI-I) and Severity Subscale (CGI-S)
The CGI-I is a one-item assessment of the clinician's sense of change in a patient's symptom burden and overall functioning. Seven response options are available with scores ranging from 1 through 7: "very much improved", "much improved", "a little improved", "no change", "a little worse", "much worse", and "very much worse". In a previous study, the CGI-I has demonstrated good inter-rater reliability at identifying responders - defined as cases rated to be "very much improved" or "much improved" (Asarnow, Emslie, Clarke et al. 2009). This measure is used broadly across RCTs for adolescent depression (Courtney et al, 2021) and will be used to select the clinical significance of our finding and render findings comparable to other studies.
Measured: Baseline to 24-weeks
Health and Social Service Utilization
This is a 10-item, self-report questionnaire that collects data regarding services and medications used by the patient.
Measured: Change from baseline to 24 weeks
Ontario Perception of Care Tool for Mental Health and Addictions
Two versions of this tool were developed by CAMH (one for registered patients and one for family members of clients) and typically consists of 38 items on a Likert scale. It standardizes how substance use, mental health, and concurrent disorder services obtain client perception of care feedback.
Measured: Change from baseline to 24 weeks
Adolescent Alcohol and Drug Involvement Scale Grid
This scale is used for adolescent substance abuse frequency. It includes both alcohol and other drug abuse.
Measured: Change from baseline to 24 weeks
Cognitive Behavioural Therapy Skills Questionnaire
This 16-item measure utilizing a Likert scale from 1 (I don't do this) to 5 (I always do this) assess an individual's cognitive restructuring and behavioral activation skills.
Measured: Change from baseline to 24 weeks
CollaboRATE
This is a 3 item measure on a 5-point Likert Scale that measures the level of shared decision making in the clinical encounter from the patient's perspective, as part of assessing health care quality and provider performance.
Measured: Change from baseline to 24 weeks
Nonsuicidal Self-Injury
This measure comes from the Self-Injurious Thoughts and Behaviors Interview, which is a structured interview that assesses the presence, frequency, and characteristics of a wide range of self-injurious thoughts and behaviors, including suicidal ideation, suicide plans, suicide gestures, suicide attempts, and nonsuicidal self-injury (NSSI). The NSSI section has been adapted for the purposes of the study.
Measured: Change from baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Feb 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- The study uses a Type 1 Hybrid Implementation Effectiveness design that focuses on the effectiveness of the clinical intervention (ICP) while exploring the implementation effectiveness of the intervention. A cluster controlled trial is indicated as the intervention is applied at the clinic-level.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Darren B Courtney, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142683
- Sponsor's protocol ID
- 019/2021
- Acronym
- CARIBOU-2
- Status last verified
- Aug 2026
- First submitted
- 3 Nov 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified research data from participants who have consented to share their study data for future unspecified research will be stored in CAMH's BrainHealth Databank (BHDB). The BHDB enables researchers to access and use these data for future research on mental health and related conditions, with the aim of advancing understanding and improving treatments and care. Any secondary use or analysis of the data will require appropriate ethics approval, as well as approval from the study sponsor and Principal Investigator.
Publications
Bennett K, Courtney D, Duda S, Henderson J, Szatmari P. An appraisal of the trustworthiness of practice guidelines for depression and anxiety in children and youth. Depress Anxiety. 2018 Jun;35(6):530-540. doi: 10.1002/da.22752. Epub 2018 Apr 26.
PubMed 29697887Courtney D, Bennett K, Henderson J, Darnay K, Battaglia M, Strauss J, Watson P, Szatmari P. A Way through the woods: Development of an integrated care pathway for adolescents with depression. Early Interv Psychiatry. 2020 Aug;14(4):486-494. doi: 10.1111/eip.12918. Epub 2019 Dec 27.
PubMed 31883210Courtney DB, Bennett K, Szatmari P. The Forest and the Trees: Evidence-Based Medicine in the Age of Information. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):8-15. doi: 10.1016/j.jaac.2018.06.035.
PubMed 30577942Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Hytman L, Mansueto S, Chan JI, Kumar R, Nguyen ATP, Wang W, Krause KR, Monga S, Szatmari P, Courtney DB. Interrater Reliability and Measurement Error of the Children's Depression Rating Scale-Revised in Adolescents. JAACAP Open. 2025 Jun 20;3(4):1225-1235. doi: 10.1016/j.jaacop.2025.06.005. eCollection 2025 Dec.
PubMed 41367969de Oliveira C, Mason J, Amani B, Liddell G, Szatmari P, Henderson J, Courtney D. Protocol for the economic evaluation of the Care for Adolescents who Received Information 'Bout Outcomes, 2nd iteration (CARIBOU-2) non-randomised, cluster-controlled trial of an integrated care pathway for depression in adolescents. BMJ Open. 2025 May 15;15(5):e092541. doi: 10.1136/bmjopen-2024-092541.
PubMed 40379352
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Integrated Care Pathway for Adolescent Depression: A Quasi-experimental, Multi-site, Cluster Controlled Trial
- ClinicalTrials.gov ID
- NCT05142683
- Acronym / sponsor ID
- CARIBOU-2 / 019/2021
- Conditions
- Major Depressive Disorder
- Keywords
- Adolescents, Integrated Care Pathway, Depression, Measurement Based Care, Implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Dec 2021 (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.
This is a quasi-experimental, multi-site cluster controlled clinical trial design with two intervention arms--Treatment As Usual (TAU) and an Integrated Care Pathway (ICP). Eligible participants are between the ages of 13 and 18, who present to community mental health agencies with depressive symptoms as the primary concern. The primary clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. The secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining implementation outcomes such as feasibility, fidelity cost and acceptability.
Detailed description
Background: Depression is the leading cause of disability in adolescents and a potent risk factor for suicide. Evidence-based treatments are available; however, many clinics do not provide guidelines-based treatments. Integrated Care Pathways (ICPs) are treatment algorithms based on the highest quality practice guidelines intended to facilitate the delivery of evidence-based treatment at the clinic level. Our group has already tested the feasibility of ICP for adolescent depression at an academic setting. There is still uncertainty regarding whether ICPs lead to improved outcomes in depression in adolescents in community settings relative to typical care.
Objective: The current study aim is to test the effectiveness of an ICP for depression in adolescence, called the CARIBOU-2 intervention, versus treatment-as-usual (TAU) in community settings. This study will also examine important implementation outcomes.
Method: The primary participants are adolescents (Up to N=150), between the ages of 13 to 18 with depressive symptoms, presenting to one of the participating sites. Through a quasi-experimental, multi-site cluster controlled clinical trial design, sites began in the TAU condition and transitioned to the ICP condition once local enrollment to TAU has reached up to 25 participants. The primary clinical outcome of interest is the difference between treatment groups in the rate of change of depressive symptoms from baseline to 24-week endpoint as measured by the Mood and Feelings Questionnaire. Secondary outcomes include rate of change of functional improvement, as measured by the Childhood Anxiety and Depression Life Interference Scale, and caregiver-rated internalizing symptoms as rated by the Childhood Behaviour Checklist. This study will also be examining the following implementation outcomes: feasibility, fidelity cost and acceptability. Implementation will also be assessed at three additional sites through a light-touch evaluation conducted several months after training and implementation of the pathway, focusing on clinicians' perspectives and experiences.
Statistical Analyses:
Descriptive data analysis will be first conducted to examine distribution of collected measures and evaluate whether there are significant differences across arms of assigned sites. Generalized linear mixed-effects model will be the primary analytic tool for evaluating whether the CARIBOU-2 intervention is more effective than TAU for adolescents with depression presenting to care with regards to improvement of depressive symptoms, self-reported functioning, caregiver-reported internalizing psychopathology, and suicidal ideation and behaviours. Time, treatment assignment and their interactions will serve as the primary predictors for the analyses. As an example, if we let Y_ijt to denote a continuous outcome of the j-th participant of the i-th site measured at time t, a linear model for Y_ijt will look like the following:
Y_ijt=β_0+〖b_(0,ij)+b_(1,i)+β〗_1 t+β_2 〖Group〗_(i,t)+β_3 Group_it*t+〖β_4 X_ijt+ϵ〗_ijt
of which 〖Group〗_(i,t) denotes the treatment assignment of the i-th site at time t, X_ijt, additional covariates, b_(0,ij) and b_(1,i), random effects at individual and site levels respectively, ϵ_( ijt), unexplained random error, and β's, regression coefficients. For sensitivity analyses, we will explore the use of the piecewise model to model the time trend differently. We will adopt the intention-to-treat approach in general and use multiple imputation methods as the primary missing data strategy. In our pilot study, we have collected ~85% of expected longitudinal data points on the MFQ (primary clinical outcome), adjusting for attrition. Sensitivity analysis will be conducted to evaluate the impact of non-random missing and robust regression method will be used instead when the impact is high. SAS 9.4 will be our go-to software package for this project.
Relevance: Should our results be consistent with our hypotheses, systematic implementation of the CARIBOU-2 intervention to other community mental health agencies and hospitals would be indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study uses a Type 1 Hybrid Implementation Effectiveness design that focuses on the effectiveness of the clinical intervention (ICP) while exploring the implementation effectiveness of the intervention. A cluster controlled trial is indicated as the intervention is applied at the clinic-level.
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | Active comparator | Other: Treatment As UsualStudy involvement for all sites will begin in the TAU condition, which is the typical treatment at the participating community mental health agency. A range of treatments observed in our previous survey of sites will be on offer in these agencies, depending on the preferences and context of the local agency. In typical TAU in community mental health agencies, depressive symptoms and function are not systematically monitored via standardized rating scales. TAU may or may not include referral to psychotherapy and/or parent support. There are no prompts to prescribe specific medications, and/or internal and external referrals to treatment and other services, guided by local service standards. |
| CARIBOU-2 | Experimental | Other: CARIBOU-2After the CARIBOU-1 pilot study, the Principal Investigator revised the ICP to render it more applicable to community settings as well as offer a second-line psychotherapy ("Brief Psychosocial Intervention") for youth who do not engage with, or respond to, cognitive-behavioural therapy. The revised version is called the CARIBOU-2 intervention. The current iteration of the pathway involves a series of steps: (1) structured assessment, including safety assessment; (2) education on depression, sleep, exercise, and diet; (3) psychotherapy (with 1st line Cognitive Behavioural Therapy, 2nd line "Brief Psychosocial Intervention"); (4) a caregiver structured support group; (5) medication options (1st line fluoxetine, 2nd line sertraline); (6) "team reviews" every four weeks, (meeting with the youth and involved clinicians to review measures and discuss treatment changes); and, (7) discharge and follow-up planning. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Youth is aged 13 to 18 years, inclusive.
- Youth and/or their caregiver is expressing that 'depression" (or some synonym) is a concern.
- Clinician agrees that depressive symptoms are a treatment target.
- Mood and Feelings Questionnaire score is ≥22 at two sequential visits (screening and baseline assessment).
- Youth must be new to the site (in past 3 months) or have a period of no treatment for 3 months
Key exclusion criteria (4 listed)
- Known or highly suspected presentations of psychotic symptoms that are persistent, affect functioning, and have observable effects on behaviour.
- Severe substance use disorder, bipolar disorder, autism spectrum disorder or intellectual disability, severe eating disorder, imminent risk of suicide requiring hospitalization as per judgment of the assessing clinician.
- Inability to provide informed consent to the study for any reason
- Youth currently in Day Treatment
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 |
|---|---|---|
| Treatment As UsualVarious typical interventions for adolescents with depression. | Other | Treatment as Usual |
| CARIBOU-2Integrated Care Pathway intervention for adolescents with depression. | Other | CARIBOU-2 |
Primary outcome
The Mood and Feelings Questionnaire (MFQ) child, long version
Time frame: Change from baseline to 24 weeks
The MFQ is a 33-item self-report measure for youth regarding depressive symptoms experienced over the prior 2 weeks. It was specifically recommended in the NICE guideline, given its strong psychometric properties; namely, it has high discriminatory ability in adolescents, good internal consistency (α=0.92-0.94) and good test-retest reliability (Pearson's r=0.78). It has also been used in a large trial of psychotherapy with adolescents where it was sensitive to change.
11 secondary outcomes
The Child Behaviour Checklist (CBCL) - Parent Report Form
Time frame: Baseline to 24-weeks
Columbia Suicide Severity Rating Scale
Time frame: Change from baseline to 24 weeks
Depression Rating Scale
Time frame: Change from baseline to 24 weeks
Youth Quality of Life Scale Research Version
Time frame: Change from baseline to 24 weeks
Clinical Global Impression Scale - both the Improvement Subscale (CGI-I) and Severity Subscale (CGI-S)
Time frame: Baseline to 24-weeks
Health and Social Service Utilization
Time frame: Change from baseline to 24 weeks
Ontario Perception of Care Tool for Mental Health and Addictions
Time frame: Change from baseline to 24 weeks
Adolescent Alcohol and Drug Involvement Scale Grid
Time frame: Change from baseline to 24 weeks
Cognitive Behavioural Therapy Skills Questionnaire
Time frame: Change from baseline to 24 weeks
CollaboRATE
Time frame: Change from baseline to 24 weeks
Nonsuicidal Self-Injury
Time frame: Change from baseline to 24 weeks
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 20 Aug 2026.
- Background: PubMed 29697887Bennett K, Courtney D, Duda S, Henderson J, Szatmari P. An appraisal of the trustworthiness of practice guidelines for depression and anxiety in children and youth. Depress Anxiety. 2018 Jun;35(6):530-540. doi: 10.1002/da.22752. Epub 2018 Apr 26.
- Background: PubMed 31883210Courtney D, Bennett K, Henderson J, Darnay K, Battaglia M, Strauss J, Watson P, Szatmari P. A Way through the woods: Development of an integrated care pathway for adolescents with depression. Early Interv Psychiatry. 2020 Aug;14(4):486-494. doi: 10.1111/eip.12918. Epub 2019 Dec 27.
- Background: PubMed 30577942Courtney DB, Bennett K, Szatmari P. The Forest and the Trees: Evidence-Based Medicine in the Age of Information. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):8-15. doi: 10.1016/j.jaac.2018.06.035.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Derived from this study: PubMed 41367969Hytman L, Mansueto S, Chan JI, Kumar R, Nguyen ATP, Wang W, Krause KR, Monga S, Szatmari P, Courtney DB. Interrater Reliability and Measurement Error of the Children's Depression Rating Scale-Revised in Adolescents. JAACAP Open. 2025 Jun 20;3(4):1225-1235. doi: 10.1016/j.jaacop.2025.06.005. eCollection 2025 Dec.
- Derived from this study: PubMed 40379352de Oliveira C, Mason J, Amani B, Liddell G, Szatmari P, Henderson J, Courtney D. Protocol for the economic evaluation of the Care for Adolescents who Received Information 'Bout Outcomes, 2nd iteration (CARIBOU-2) non-randomised, cluster-controlled trial of an integrated care pathway for depression in adolescents. BMJ Open. 2025 May 15;15(5):e092541. doi: 10.1136/bmjopen-2024-092541.
- Individual participant dataSharing planned: Yes. De-identified research data from participants who have consented to share their study data for future unspecified research will be stored in CAMH's BrainHealth Databank (BHDB). The BHDB enables researchers to access and use these data for future research on mental health and related conditions, with the aim of advancing understanding and improving treatments and care. Any secondary use or analysis of the data will require appropriate ethics approval, as well as approval from the study sponsor and Principal Investigator.
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The Immunobiological Mechanisms of Depression in Perimenopause
Perimenopause, Major Depressive Episode (MDE)
Not yet recruiting
Effectiveness of Internet-based Unified Protocol (iUP) for Emotional Problems: A Randomized Controlled Trial
Depression - Major Depressive Disorder, Generalised Anxiety Disorder
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.
Eva Gonzalez Villanueva, Research Coordinator, MPH, MSSW, RSW contact
Darren B Courtney, MD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment As Usual and CARIBOU-2 in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site 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 5 inclusion and 4 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Darren B Courtney, MD (800-463-2338 ext. 30539, dr.courtney.research@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mood and Feelings Questionnaire (MFQ) child, long version (time frame: Change from baseline to 24 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 NCT05142683, which also lists 6 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 20 Aug 2026.