Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized 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.

NCT Number	NCT05142683
Lead Sponsor	Centre for Addiction and Mental Health Collaborators: Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
Conditions	Major Depressive Disorder
Enrollment	300 participants
Start Date	2022-02-01
Primary Completion	2027-09-30 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-13