Recruiting

TAU & ICP

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT05142683

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Accepted

Interventions

Treatment As Usual

CARIBOU-2

Study Details

Brief 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 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.

Conditions

Major Depressive Disorder

Study ID

NCT05142683

Start date

Feb 1, 2022

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Treatment As Usual

Various typical interventions for adolescents with depression.

CARIBOU-2

Integrated Care Pathway intervention for adolescents with depression.

Primary outcome measure

  • The Mood and Feelings Questionnaire (MFQ) child, long version [ Time Frame: Change from baseline to 24 weeks ]

Central Contacts and Locations

Central contacts

Darren B Courtney, MD

800-463-2338dr.courtney.research@gmail.com

Eva Gonzalez Villanueva, Research Coordinator, MPH, MSSW, RSW

800-463-2338eva.gonzalezvillanueva@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada

Contacts

Katye Stevens, Research Operations Manager

800-463-2338Katye.Stevens@camh.ca

Eva Gonzalez Villanueva, Research Coordinator, MPH, MSSW, RSW

800-463-2338eva.gonzalezvillanueva@camh.ca

Principal Investigator:

Darren B Courtney, MD

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Adolescents
  • Integrated Care Pathway
  • Depression
  • Measurement Based Care
  • Implementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-08-20.