Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)

NCT ID: NCT07020572

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-06-30

Brief 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

Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST)

Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST) is an indicated group depression prevention program adapted from Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST). In B-IPT-AST, adolescents learn communication (e.g., using I statements, striking while the iron is cold) and interpersonal problem-solving strategies and apply these strategies to their relationships to decrease conflict, increase social support, and improve overall social functioning. B-IPT-AST consists of 1 individual pre-group sessions, 1 individual mid-group session, and 4 group sessions. Parents are invited to attend the mid-group session so the adolescents can apply the interpersonal strategies in a conversation with a parent.

Group Type: EXPERIMENTAL

Brief Interpersonal Psychotherapy - Adolescent Skills Training (B-IPT-AST)

Intervention Type: BEHAVIORAL

This is an adolescent depression prevention program consisting of 6 sessions (4 group and 2 individual sessions).

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.

Group Type: ACTIVE_COMPARATOR

Services as usual (SAU)

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

For Adolescent Participants

1. Adolescents ages 13 to 17 years.

2. Adolescents must be English-speaking.

3. Legal guardian permission (informed consent) and child consent/assent.

4. A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit.

5. Access to a phone, computer, or other electronic device that could be used for study activities

For Legal guardian Participants

1. Legal guardian of an adolescents ages 13 to 17 years who scored 5-10 on the PHQ-9-M at the primary care well-visit.

2. Consent to participate.

3. English-speaking.

4. Access to a phone, computer, and/or tablet to complete remote evaluations.

Exclusion Criteria

1. Suicidal ideation or behaviors reported on the PHQ-9-M at their well-visit (score of 1 or higher on item 9 "In the past week, have you had thoughts that you would be better off dead, or of hurting yourself in some way?" and/or yes to either of the supplemental questions which ask, "Has there been a time in the past month when you have had serious thoughts about ending your life?" and "Have you ever, in your whole life, tried to kill yourself or made a suicide attempt?") based on medical record review. For the PHQ-9-M administered at baseline, adolescents who mark yes to the supplemental item about serious suicidal ideation in the past month ("Has there been a time in the past month when you have had serious thoughts about ending your life?") will be excluded.

2. Major medical illness, significant behavioral problems or intellectual or developmental disabilities that may interfere with the completion of all study procedures.

3. Youth may be excluded on a case-by-case basis if the EHR review, eligibility screener, baseline evaluation, or other interactions with the family suggests that the group program would not be appropriate.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Klingenstein Third Generation Foundation

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Molly F Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Molly F Davis, PhD

Role: CONTACT

davismf@chop.edu

2674250721

Jami F. Young, PhD

Role: CONTACT

youngjf@chop.edu

2674251328

Facility Contacts

Molly F Davis, PhD

Role: primary

davismf@chop.edu

267-425-0721

Jami F Young, PhD

Role: backup

youngjf@chop.edu

267-425-1328

Other Identifiers

24-023018

Identifier Type: -

Identifier Source: org_study_id