Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial (CARIBOU-2)

August 18, 2026 updated by: Centre for Addiction and Mental Health

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Centre for Addiction and Mental Health
        • Contact:
          • Katye Stevens, Research Operations Manager
          • Phone Number: 34914 800-463-2338
          • Email: Katye.Stevens@camh.ca
        • Contact:
        • Principal Investigator:
          • Darren B Courtney, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as Usual
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.
Other: Treatment As Usual
Various typical interventions for adolescents with depression.
Experimental: CARIBOU-2
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.
Other: CARIBOU-2
Integrated Care Pathway intervention for adolescents with depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Columbia Suicide Severity Rating Scale
Time Frame: Change from baseline to 24 weeks
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.
Change from baseline to 24 weeks
Depression Rating Scale
Time Frame: Change from baseline to 24 weeks
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.
Change from baseline to 24 weeks
Youth Quality of Life Scale Research Version
Time Frame: Change from baseline to 24 weeks
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.
Change from baseline to 24 weeks
Health and Social Service Utilization
Time Frame: Change from baseline to 24 weeks
This is a 10-item, self-report questionnaire that collects data regarding services and medications used by the patient.
Change from baseline to 24 weeks
Ontario Perception of Care Tool for Mental Health and Addictions
Time Frame: Change from baseline to 24 weeks
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.
Change from baseline to 24 weeks
Adolescent Alcohol and Drug Involvement Scale Grid
Time Frame: Change from baseline to 24 weeks
This scale is used for adolescent substance abuse frequency. It includes both alcohol and other drug abuse.
Change from baseline to 24 weeks
Cognitive Behavioural Therapy Skills Questionnaire
Time Frame: Change from baseline to 24 weeks
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.
Change from baseline to 24 weeks
CollaboRATE
Time Frame: Change from baseline to 24 weeks
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.
Change from baseline to 24 weeks
Nonsuicidal Self-Injury
Time Frame: Change from baseline to 24 weeks
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.
Change from baseline to 24 weeks
The Child Behaviour Checklist (CBCL) - Parent Report Form
Time Frame: Baseline to 24-weeks
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.
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
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.
Baseline to 24-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Darren B Courtney, MD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

November 3, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

August 20, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 019/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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 from the end of the study through 10 years after study completion (approximately 2028-2038).

IPD Sharing Access Criteria

Eligible de-identified research data will be stored in CAMH's BrainHealth Databank. Any secondary use or analysis of the data will require appropriate ethics approval, as well as approval from the study sponsor and/or Principal Investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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