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

Sponsor: Centre for Addiction and Mental Health • ClinicalTrials.gov ID: NCT05142683

Registry updated: 2026-08-20

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Description

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

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

Eligibility criteria

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

Conditions

Major Depressive Disorder

Locations

Centre for Addiction and Mental Health — Toronto, Ontario, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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