Recruiting
Improving Mood for Adolescents Through Teaming With End-Users in Routine Care (The iMATTER Project)
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.
ClinicalTrials.gov IDNCT07020572
PhaseNA
Enrollment45
SponsorChildren's Hospital of Philadelphia
Age13 Years
SexALL
Conditions studied
Depressive Symptoms
About this study
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.
Interventions
- 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.
Primary outcomes
- Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI) (0-6 Weeks Post-Intervention)
- Attendance (Weekly during B-IPT-AST)
- Retention (Baseline, 0-6 Weeks Post-Intervention)
- Depression symptoms (Baseline, 0-6 Weeks Post-Intervention)
- Depression symptoms (Baseline, 0-6 Weeks Post-Intervention)
- Anxiety symptoms (Baseline, 0-6 Weeks Post-Intervention)
Eligibility information
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.
Study locations
- Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19146 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.