Clinical trial NCT04109716: School Adolescent Mood Project: Efficacy of IPT-AST in Schools
Official title: School Adolescent Mood Project: Efficacy of IPT-AST in Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Institute of Education Sciences
First posted: 2019-09-30
Enrollment: 242
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Depression symptoms
timeFrame: Screen, baseline, 2 month, 3 month, 9 month, 15 month
measure: Impairment
timeFrame: Baseline, 2 month, 3 month, 9 month, 15 month
measure: Onset of depression diagnoses
timeFrame: Eligibility, 15 month
measure: Change in academic grades
timeFrame: Baseline, 15 month
measure: Change in school attendance
timeFrame: Baseline, 15 month
Secondary outcomes:
measure: Internalizing and externalizing symptoms
timeFrame: Baseline, 2 month, 3 month, 9 month, 15 month
measure: Anxiety symptoms
timeFrame: Baseline, 2 month, 3 month, 9 month, 15 month
measure: Number of disciplinary incidents
timeFrame: Baseline, 15 month
measure: School connectedness
timeFrame: Baseline, 3 month, 9 month, 15 month
measure: Emotional and behavioral engagement in learning
timeFrame: Baseline, 3 month, 9 month, 15 month
measure: Fidelity to the intervention
timeFrame: Weekly during intervention delivery
measure: Acceptability - counselors: A self-report measure, Counselor Feedback Form
timeFrame: 3 month, 15 month
measure: Acceptability - adolescents: A self-report measure, the Attitude Towards Intervention Questionnaire (ATI)
timeFrame: 3 month, 15 month
measure: Patterns in qualitative data
timeFrame: 3 month
measure: Attendance
timeFrame: Weekly during IPT-AST
Other outcomes:
measure: Perspective-taking
timeFrame: Baseline, 2 month, 3 month, 9 month, 15 month
measure: Social functioning
timeFrame: Baseline, 2 month, 3 month, 9 month, 15 month
measure: Quality of relationships: Inventory of Parent and Peer Attachment (IPPA-45)
timeFrame: Baseline, 2 month, 3 month, 9 month, 15 month
measure: Parent-child conflict
timeFrame: Baseline, 2 month, 3 month, 9 month, 15 month
Locations:
city: Philadelphia
country: United States
facility: Children's Hopsital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: CHOP, University of Pennsylvania Perelman School of Medicine
name: Jami Young, PhD
role: PRINCIPAL_INVESTIGATOR
References: