Clinical trial NCT07020572: Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)
Official title: The iMATTER Project: Preventing Adolescent Depression in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: The Klingenstein Third Generation Foundation
First posted: 2025-06-13
Enrollment: 45
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

Exclusion criteria will be determined based on electronic health record (EHR) review, eligibility screening questions, the baseline evaluation, and any other interactions with the family.

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.

Primary outcomes:
measure: Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)
timeFrame: 0-6 Weeks Post-Intervention
measure: Attendance
timeFrame: Weekly during B-IPT-AST
measure: Retention
timeFrame: Baseline, 0-6 Weeks Post-Intervention
measure: Depression symptoms
timeFrame: Baseline, 0-6 Weeks Post-Intervention
measure: Depression symptoms
timeFrame: Baseline, 0-6 Weeks Post-Intervention
measure: Anxiety symptoms
timeFrame: Baseline, 0-6 Weeks Post-Intervention
Secondary outcomes:
measure: Internalizing and externalizing symptoms
timeFrame: Baseline, 0-6 Weeks Post-Intervention
measure: Impairment (Child Report)
timeFrame: Baseline, 0-6 Weeks Post-Intervention
measure: Impairment (Parent Report)
timeFrame: Baseline, 0-6 Weeks Post-Intervention
measure: Perspective-taking
timeFrame: Baseline, 0-6 Weeks Post-Intervention
measure: Social functioning
timeFrame: Baseline, 0-6 Weeks Post-Intervention
measure: Parent-child conflict (child report)
timeFrame: Baseline, 0-6 Weeks Post-Intervention
measure: Parent-child conflict (parent report)
timeFrame: Baseline, 0-6 Weeks Post-Intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine
name: Molly F Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References: