NCT05142683Recruiting
Effectiveness of an Integrated Care Pathway for Depression: Cluster Randomized Controlled Trial
Effectiveness of an Integrated Care Pathway for Adolescent Depression: A Quasi-experimental, Multi-site, Cluster Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 3 Nov 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Depression
- NCT number
- NCT05142683
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Feb 2022 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Known or highly suspected presentations of psychotic symptoms that are persistent, affect functioning, and have observable effects on behaviour.
- Inability to provide informed consent to the study for any reason
- Youth currently in Day Treatment
Who the study is looking for
- 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
Age in the registry: 13 years to 18 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
Related publications
- Interrater Reliability and Measurement Error of the Children's Depression Rating Scale-Revised in Adolescents.JAACAP Open · 2025 · PMID 41367969
This page is information, not medical advice. Discuss any trial with your doctor.