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

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Depressive Symptoms

Treatments: Behavioral: Services as usual; Behavioral: Interpersonal Psychotherapy - Adolescent Skills Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04109716

R305A190088 (Other Grant/Funding Number)

19-016323

Details and patient eligibility

About

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.

Full description

This is a randomized clinical trial. Adolescents with elevated depressive symptoms will be identified and randomly assigned to IPT-AST delivered through telehealth by research staff (alone or in collaboration with school support staff) or services as usual (SAU) as delivered by counselors or other student support staff in schools. The research team will use longitudinal data collection with adolescents, parents, and counselors, and will collect data from teachers and school records to achieve study objectives.

Participants will be 240 racially and ethnically diverse students in the 9th and 10th grades between the ages of 14 and 17 with elevated symptoms of depression and their parents. Counselors in local high schools will also be study participants. A subset of counselors, adolescents, and administrators will also participate in a qualitative interview as part of an implementation study.

Adolescent participants will be randomly assigned to IPT-AST, an evidence-based depression prevention program, or SAU which may include supportive counseling and/or referral for services.

Standardized measures for adolescents, parents, and teachers and school records will be used to examine emotional outcomes (e.g., depression and anxiety symptoms, depression diagnoses) and school outcomes (e.g., school engagement, grades). Investigators will utilize standardized measures to assess social processes (e.g., interpersonal conflict, social functioning) that may mediate the effects of the intervention on these emotional and school outcomes. Investigators will also collect data on services received in IPT-AST and SAU, techniques utilized in both conditions, and feasibility, acceptability, fidelity, sustainability, and costs of IPT-AST using session logs, time diaries, standardized measures, leader- and consultant-rated fidelity checklists, and qualitative interviews.

Enrollment: 242 patients

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Adolescent Participants

Inclusion Criteria:

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

Exclusion Criteria:

1. Less than 2 threshold or subthreshold symptoms on the K-SADS-PL
2. 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
3. Significant cognitive or language impairments requiring placement in Special Education as reported by the parent or as evident in the eligibility evaluation
4. 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

Inclusion Criteria:

1. Parents of students in 9th or 10th grade between the ages of 14 and 17 at one of the participating schools
2. English or Spanish-speaking or limited English proficiency with use of interpreter
3. Consent to participate
4. Have access to a phone, computer, and/or tablet to complete remote evaluations

Exclusion Criteria:

None

For Parent-Designated Adult Family Member Participants (in cases where parent asks a different family member to complete parent assessments)

Inclusion Criteria:

1. 18 years of age or older
2. Knows the adolescent well enough to answer questions about him/her
3. English or Spanish-speaking or limited English proficiency with use of interpreter
4. Consent to participate
5. Have access to a phone, computer, and/or tablet to complete remote evaluations

Exclusion Criteria:

None

For Counselor Participants

Inclusion Criteria:

1. Counselor at one of the participating high schools
2. Consent to participate
3. Have access to a phone, computer, and/or tablet to complete remote evaluations

Exclusion Criteria:

None

For Teacher and Administrator Participants

Inclusion Criteria:

1. Teacher or administrator at one of the participating high schools
2. Consent to participate in the qualitative interview
3. Have access to a phone, computer, and/or tablet to complete remote evaluations

Exclusion Criteria:

None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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242 participants in 2 patient groups

Interpersonal Psychotherapy-Adolescent Skills Training

Experimental group

Description:

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.

Treatment:

Behavioral: Interpersonal Psychotherapy - Adolescent Skills Training

Services as Usual (SAU)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Services as usual