Evaluating an Integrated Care Pathway for treating adolescent depression
Effectiveness of an Integrated Care Pathway for Adolescent Depression: A Quasi-experimental, Multi-site, Cluster Controlled Trial (Edited on March 7th, 2024)
This study is testing a new treatment approach for teens aged 13 to 18 with depression to see if it helps them feel better compared to the usual care they receive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05142683 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of an Integrated Care Pathway (ICP) for adolescents aged 13 to 18 with major depressive disorder, comparing it to Treatment As Usual (TAU). The study employs a stepped wedge cluster randomized controlled design across six community mental health agencies, where all sites will initially provide TAU before transitioning to the ICP in a randomized sequence. The primary goal is to assess the clinical improvement in depressive symptoms and functioning among participants receiving the ICP. Additionally, the study will evaluate the feasibility, fidelity, cost, and acceptability of implementing the ICP in community settings.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13 to 18 who present with depressive symptoms and have a Mood and Feelings Questionnaire score of 22 or higher.
Not a fit: Patients with severe mental health conditions such as psychosis, severe substance use disorders, or those currently in day treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for adolescents suffering from depression.
How similar studies have performed: Previous studies have shown promise in using Integrated Care Pathways for adolescent depression, but this specific approach is being tested in a community setting for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Darren B Courtney, MD — University of Toronto
- Study coordinator: Michelle U Ferreira, MEd
- Email: michelle.ferreira@camh.ca
- Phone: 4165358501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.