Trials / Recruiting
RecruitingNCT07020572
Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)
The iMATTER Project: Preventing Adolescent Depression in Pediatric Primary Care
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Children's Hospital of Philadelphia · Academic / Other
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This pilot randomized controlled trial will examine the feasibility, acceptability and preliminary efficacy of an adolescent depression prevention program, Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST), in primary care.
Detailed description
Depression is prevalent during adolescence and is associated with negative outcomes. Most adolescent depression prevention programs require significant time and resources. To reduce the research-to-practice gap, the present study will test an adapted version of an evidence-based depression preventive intervention, Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), to promote its implementation in primary care (PC). Specifically, a brief, scalable prevention program, Brief IPT-AST (B-IPT-AST), will be tested in a pilot randomized controlled trial in PC. The pilot randomized controlled trial will include adolescents ages 13-17 with subthreshold depression scores on a depression screener, the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M), completed during an annual PC well-visit. Adolescents will be randomly assigned (2:1 allocation) to B-IPT-AST or services as usual (SAU). Members of the research team will deliver B-IPT-AST. Standardized measures for adolescents and legal guardians will be used to examine emotional outcomes (e.g., depression and anxiety symptoms). Standardized measures will be utilized to assess social processes (e.g., interpersonal conflict). All adolescents randomized to B-IPT-AST will complete a survey measuring acceptability of B-IPT-AST. Additionally, a subset of adolescents who participate in B-IPT-AST will be invited to participate in an hour-long qualitative interview to give feedback on their experiences with B-IPT-AST to inform any further modifications needed to enhance the program's feasibility and acceptability. Feasibility will also be assessed via recruitment and retention information and B-IPT-AST attendance logs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST) | This is an adolescent depression prevention program consisting of 6 sessions (4 group and 2 individual sessions). |
| BEHAVIORAL | Services as usual (SAU) | Services as usual (SAU) involves any mental health services adolescents decide to receive in primary care or in the community. It is possible that adolescents in SAU may decide not to participate in any mental health services. |
Timeline
- Start date
- 2025-03-20
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2025-06-13
- Last updated
- 2025-06-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07020572. Inclusion in this directory is not an endorsement.