Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings

Study Overview
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Brief Summary
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This study is a randomized controlled trial comparing Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) to group counseling (GC) for the prevention of depression in adolescents. The project will: (1) identify adolescents with elevated depressive symptoms but who do not meet criteria for a current mood disorder diagnosis; (2) randomize eligible adolescents to either IPT-AST (N = 100) or GC (N = 100); (3) assess depressive symptoms, depressive disorders, global functioning, interpersonal functioning, comorbid conditions and school related indices at baseline, mid-intervention, post-intervention, and at 6-, 12-, 18-, and 24-month follow-up; (4) examine the effects of IPT-AST on depression and various domains of functioning at each time point; and (5) conduct analyses to examine potential mediators and moderators of the association between IPT-AST and depression outcomes. This study will yield data on the efficacy of IPT-AST relative to GC for the prevention of depressive symptoms and depressive disorders. It will also provide information about the mechanisms of action of IPT-AST and determine for whom IPT-AST is most effective.

Official Title
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Depression Prevention Initiative - A Study of IPT-AST in School Settings

Conditions
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Depression

Intervention / Treatment
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* Behavioral: IPT-AST
* Behavioral: Group Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In 7th-10th grades at intake Center for Epidemiologic Studies Depression Scale(CES-D) Score > 16 At least 2 symptoms on the K-SADS depression section (score of 2 or 3), one of which is either depressed mood, irritability, or anhedonia Adolescent must be English-speaking Parent speaks English or Spanish Exclusion Criteria: CES-D Score < 15 Fewer than 2 depression symptoms on the K-SADS (score of 2 or 3) or 2 or more symptoms on the K-SADS with no report of depressed mood, irritability, or anhedonia Suicide attempt or self-mutilation in the past year, current active suicidal ideation, and/or history of a clinically significant suicidal behavior (i.e., with intent to die and high medical lethality) or repeated patterns of self-injurious behavior Presence of current Major Depressive Disorder, dysthymia, substance abuse, schizophrenia, bipolar disorder, conduct disorder, or psychosis

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPT-AST<br>Interpersonal Psychotherapy-Adolescent Skills Training | Behavioral: IPT-AST<br>* A school-based group prevention program that includes 2 individual pre-group sessions, 8 weekly 90 minute group sessions, an individual mid-group session and 4 booster sessions<br>* Other names: Interpersonal Psychotherapy-Adolescent Skills Training;|
| Active Comparator: Group Counseling<br>Group Counseling | Behavioral: Group Counseling<br>* Usual group counseling as delivered by school counselors; 1 pre-group session, 1 mid-group session, 8 90-minute group sessions, 4 booster sessions<br>* Other names: Usual group counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder Not Otherwise Specified (NOS) on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL) | Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation | Post intervention (approximately 3 months post baseline) | 
| Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL |  | 6-months post-intervention | 
| Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL |  | 12-months post-intervention | 
| Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL |  | 18-months post-intervention | 
| Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL |  | 24-months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Depression Rating Scale-Revised (CDRS-R) | Scores on the CDRS-R | Post intervention (approximately 3 months after baseline) | 
| Children's Depression Rating Scale-Revised |  | 6-months post-intervention | 
| Children's Depression Rating Scale-Revised |  | 12-months post-intervention | 
| Children's Depression Rating Scale-Revised |  | 18-months post-intervention | 
| Children's Depression Rating Scale-Revised |  | 24 months post-intervention | 
| Children's Global Assessment Scale (CGAS) | Assesses global functioning | Post intervention (approximately 3 months following baseline) | 
| Children's Global Assessment Scale |  | 6-months post-intervention | 
| Children's Global Assessment Scale |  | 12-months post-intervention | 
| Children's Global Assessment Scale |  | 18-months post-intervention | 
| Children's Global Assessment Scale |  | 24-months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Prevention, Adolescents