Recruiting

B-IPT-AST

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07020572

Conditions

Depressive Symptoms

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

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

Services as usual (SAU)

Study Details

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.

Conditions

Depressive Symptoms

Study ID

NCT07020572

Start date

Mar 20, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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).

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 outcome measure

  • Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI) [ Time Frame: 0-6 Weeks Post-Intervention ]
  • Attendance [ Time Frame: Weekly during B-IPT-AST ]
  • Retention [ Time Frame: Baseline, 0-6 Weeks Post-Intervention ]
  • Depression symptoms [ Time Frame: Baseline, 0-6 Weeks Post-Intervention ]
  • Depression symptoms [ Time Frame: Baseline, 0-6 Weeks Post-Intervention ]
  • Anxiety symptoms [ Time Frame: Baseline, 0-6 Weeks Post-Intervention ]

Central Contacts and Locations

Central contacts

Molly F Davis, PhD

2674250721davismf@chop.edu

Jami F. Young, PhD

2674251328youngjf@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19146

Contacts

Principal Investigator:

Molly F Davis, PhD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-06-15.