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

Children's Hospital of Philadelphia242 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

242

Conditions

Depressive Symptoms

Interventions

Interpersonal Psychotherapy - Adolescent Skills TrainingBEHAVIORAL

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.

Services as usualBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 14 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hopsital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 15 month

Secondary Outcomes

Internalizing and externalizing symptoms

Changes in internalizing and externalizing symptoms will be assessed by the Pediatric Symptom Checklist (PSC-17), which will be completed by teens, parents, and teachers; there is a total score (range of 0-34), internalizing subscale (0-24), externalizing subscale (0-20), and attention problems subscale (0-24); higher scores indicate more symptoms

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.