School Adolescent Mood Project: Efficacy of IPT-AST in Schools

NCT04109716 | Completed

• 2 other identifiers: 19-016323R305A190088
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

This school-based randomized controlled trial will: a) examine the effects of telehealth-administered Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program, as compared to services as usual (SAU) on social processes and emotional and school outcomes, b) examine moderators and mediators of intervention effects, and c) assess the costs, cost-effectiveness, acceptability, feasibility, fidelity, and sustainability of IPT-AST.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (5)

• 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

  Screen, baseline, 2 month, 3 month, 9 month, 15 month

• Impairment

  Change in impairment will be measured by the Columbia Impairment Scale (CIS), 13-item scale of overall functioning; scores range from 0-52; a score of 15 or higher is considered elevated impairment; higher scores represent greater impairment

  Baseline, 2 month, 3 month, 9 month, 15 month

• Onset of depression diagnoses

  The onset of diagnoses/change in depression diagnoses during the study period from eligibility to the 15 month assessment will be assessed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-PL)

  Eligibility, 15 month

• Change in academic grades

  Impact of the intervention on school grades will be examined by accessing school records and looking at change in grades from baseline to the 15 month assessment.

  Baseline, 15 month

• Change in school attendance

  Impact of the intervention on school attendance will be examined by accessing school records and looking at change in attendance from baseline through 15 months.

  Baseline, 15 month

Secondary Outcomes (10)

• Internalizing and externalizing symptoms

  Baseline, 2 month, 3 month, 9 month, 15 month

• Anxiety symptoms

  Baseline, 2 month, 3 month, 9 month, 15 month

• Number of disciplinary incidents

  Baseline, 15 month

• School connectedness

  Baseline, 3 month, 9 month, 15 month

• Emotional and behavioral engagement in learning

  Baseline, 3 month, 9 month, 15 month

Other Outcomes (4)

• Perspective-taking

  Baseline, 2 month, 3 month, 9 month, 15 month

• Social functioning

  Baseline, 2 month, 3 month, 9 month, 15 month

• Quality of relationships: Inventory of Parent and Peer Attachment (IPPA-45)

  Baseline, 2 month, 3 month, 9 month, 15 month

Study Arms (2)

Interpersonal Psychotherapy-Adolescent Skills Training

EXPERIMENTAL

Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) is an indicated group depression prevention program. In 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. IPT-AST consists of 1 or 2 individual pre-group sessions, 1 mid-group session, 8 weekly group sessions, and up to 6 individual booster sessions. Parents are invited to attend the mid-group session so the adolescents can apply the interpersonal strategies in a conversation with a parent. The purpose of the booster sessions is to monitor symptoms and apply the interpersonal strategies to current stressors. These sessions are designed to help solidify the interpersonal skills and address current problems before they result in a worsening of symptoms.

Behavioral: Interpersonal Psychotherapy - Adolescent Skills Training

Services as Usual (SAU)

ACTIVE COMPARATOR

Investigators anticipate that counselors in SAU will see youth in the study for brief, periodic sessions and/or will refer youth for treatment in the community. Counselors will be permitted to see the adolescents as often as they would like throughout the course of the study (up to 15-months post-baseline). Investigators will ask counselors to complete a form each time they see a teen, noting the length of the session, whether the session was scheduled or not, and the topics discussed.

Behavioral: Services as usual

Interventions

Interpersonal Psychotherapy - Adolescent Skills Training BEHAVIORAL

This is an indicated group depression prevention consisting of 2 individual pre-group sessions, 8 weekly group session, and up to 6 individual booster sessions. IPT-AST will be delivered predominately through telehealth.

Interpersonal Psychotherapy-Adolescent Skills Training

Services as usual BEHAVIORAL

Services as usual is expected to be brief periodic sessions (in person or remote) with the school counselor or services in the community.

Services as Usual (SAU)

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescents in 9th or 10th grade between the ages of 14 and 17
• Adolescent must be English-speaking; parents must be English or Spanish-speaking
• Parental/guardian permission (informed consent) and child assent/consent
• A score of 16 or higher on the CES-D AND at least 2 threshold or subthreshold symptoms on the K-SADS-PL
• Have access to a cellular phone, computer, and/or tablet and have internet access to complete the remote intervention and evaluations

You may not qualify if:

• Less than 2 threshold or subthreshold symptoms on the K-SADS-PL
• Significant current active suicidal ideation reported on the K-SADS-PL at the eligibility evaluation or suicide attempt in the past year reported on the K-SADS-PL at the eligibility evaluation
• Significant cognitive or language impairments requiring placement in Special Education as reported by the parent or as evident in the eligibility evaluation
• Youth may be excluded on a case-by-case basis if the eligibility/baseline evaluation suggests that the group program would not be appropriate (for, instance, in the case of significant behavioral problems in the baseline evaluation).
• For Parent Participants
• Parents of students in 9th or 10th grade between the ages of 14 and 17 at one of the participating schools
• English or Spanish-speaking or limited English proficiency with use of interpreter
• Consent to participate
• Have access to a phone, computer, and/or tablet to complete remote evaluations
• None
• For Parent-Designated Adult Family Member Participants (in cases where parent asks a different family member to complete parent assessments)
• years of age or older
• Knows the adolescent well enough to answer questions about him/her
• English or Spanish-speaking or limited English proficiency with use of interpreter
• Consent to participate

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Institute of Education Sciences: collaborator

Study Sites (1)

Children's Hopsital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (1)

• Young JF, Jones JD, Schwartz KTG, So A, Dysart GC, Kanine RM, Gillham JE, Gallop R, Davis M. Telehealth-delivered depression prevention: Short-term outcomes from a school-based randomized controlled trial. J Consult Clin Psychol. 2025 Apr;93(4):213-225. doi: 10.1037/ccp0000913. Epub 2024 Oct 31.

  PMID: 39480285 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jami Young, PhD

  CHOP, University of Pennsylvania Perelman School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 30, 2019
• Study Start: August 15, 2019
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The cleaned, de-identified dataset, including additional derived variables, will be made accessible per IES data access requirements at the time that findings are published in a peer-reviewed journal. Data will be available for 10 years from that time.
• Access Criteria: Individuals interested in using the data should contact Dr. Young to make a request. Only de-identified data will be shared.

Locations

US (1)