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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

TypeNameDescription
BEHAVIORALBrief 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).
BEHAVIORALServices 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.