Recruiting

Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial

ClinicalTrials.gov IDNCT05142683

PhaseNA

Enrollment300

SponsorCentre for Addiction and Mental Health

Age13 Years

SexALL

I'm interested View official listing

Conditions studied

Major Depressive Disorder

About this study

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.

Interventions

Other: Treatment As Usual — Various typical interventions for adolescents with depression.
Other: CARIBOU-2 — Integrated Care Pathway intervention for adolescents with depression.

Primary outcomes

The Mood and Feelings Questionnaire (MFQ) child, long version (Change from baseline to 24 weeks)

Eligibility information

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 locations

Centre for Addiction and Mental Health, Toronto, Ontario Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.