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

NCT07020572 | Recruiting

• 1 other identifier: 24-023018
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Acceptability: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)

  A self-report measure, the Attitude Towards Intervention Questionnaire (ATI), will be completed by adolescents to assess acceptability of Brief Interpersonal Psychotherapy-Adolescent Skills Training (B-IPT-AST) following the intervention. The ATI includes 11 Likert scale items and one open-ended item for providing additional feedback. Likert scales vary by item but are generally 3- or 5-point scales (e.g., very helpful to very unhelpful). Each item is interpreted on its own (e.g., the percentage of teens who found B-IPT-AST very or a little helpful)

  0-6 Weeks Post-Intervention

• Attendance

  The number of individual and group B-IPT-AST sessions that teens attend will be tracked in order to report on the average number of group sessions attended (out of 4) for the total sample as well as the average number of individual sessions (out of 2) attended across the sample

  Weekly during B-IPT-AST

• Retention

  To gauge feasibility, retention will be assessed by comparing the number of families who remain in the study through post-intervention to the number who consented.

  Baseline, 0-6 Weeks Post-Intervention

• Depression symptoms

  Change in depression symptoms will be measured by the Center for Epidemiologic Studies-Depression Scale (CES-D) which assesses the frequency of 20 depressive symptoms over the past week; CES-D scores range from 0 to 60 (scores of 16 or higher are considered elevated); higher scores indicate more depression symptoms

  Baseline, 0-6 Weeks Post-Intervention

• Depression symptoms

  Change in depression symptoms will also be measured by the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M). The PHQ-9-M assesses depression symptoms over the past 2 weeks and includes 13 items, 9 of which are included in the total score. Total scores range from 0-27, with higher scores indicating more depression symptoms

  Baseline, 0-6 Weeks Post-Intervention

• Anxiety symptoms

  Change in anxiety symptoms will be assessed by the Screen for Child Anxiety Related Disorders (SCARED), a 41-item scale assessing symptoms corresponding to different anxiety disorders; the study team will examine total scores and the following subscales: panic, generalized anxiety disorder, and social anxiety; total scores range from 0-82 (25 or higher indicates clinical range); panic scores range from 0-26 (7 or higher indicates clinical range); generalized anxiety disorder scores range from 0-18 (scores of 9 or higher indicates clinical range); social anxiety scale ranges from 0-14 (scores 8 or higher indicate clinical range)

  Baseline, 0-6 Weeks Post-Intervention

Secondary Outcomes (7)

• Internalizing and externalizing symptoms

  Baseline, 0-6 Weeks Post-Intervention

• Impairment (Child Report)

  Baseline, 0-6 Weeks Post-Intervention

• Impairment (Parent Report)

  Baseline, 0-6 Weeks Post-Intervention

• Perspective-taking

  Baseline, 0-6 Weeks Post-Intervention

• Social functioning

  Baseline, 0-6 Weeks Post-Intervention

Study Arms (2)

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

EXPERIMENTAL

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.

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

Services as usual (SAU)

ACTIVE COMPARATOR

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.

Behavioral: Services as usual (SAU)

Interventions

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

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

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

Services as usual (SAU) 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.

Services as usual (SAU)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• For Adolescent Participants
• Adolescents ages 13 to 17 years.
• Adolescents must be English-speaking.
• Legal guardian permission (informed consent) and child consent/assent.
• A score of 5-10 on the Patient Health Questionnaire 9-Item: Modified for Teens (PHQ-9-M) at the primary care well-visit.
• Access to a phone, computer, or other electronic device that could be used for study activities
• For Legal guardian Participants
• 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.
• Consent to participate.
• English-speaking.
• Access to a phone, computer, and/or tablet to complete remote evaluations.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• The Klingenstein Third Generation Foundation: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Molly F Davis, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molly F Davis, PhD

CONTACT

2674250721; davismf@chop.edu

Jami F. Young, PhD

CONTACT

2674251328; youngjf@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 13, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)