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

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Completed

CT.gov ID

NCT01201382

Collaborator

National Institute of Mental Health (NIMH) (NIH), Rutgers University (Other)

185

Enrollment

Locations

Arms

Duration (Months)

92.5

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: IPT-AST Behavioral: Group Counseling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

185 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IPT-AST Interpersonal Psychotherapy-Adolescent Skills Training	Behavioral: IPT-AST 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 Other Names: Interpersonal Psychotherapy-Adolescent Skills Training
Active Comparator: Group Counseling Group Counseling	Behavioral: Group Counseling Usual group counseling as delivered by school counselors; 1 pre-group session, 1 mid-group session, 8 90-minute group sessions, 4 booster sessions Other Names: Usual group counseling

Arm

Intervention/Treatment

Experimental: IPT-AST

Interpersonal Psychotherapy-Adolescent Skills Training

Behavioral: IPT-AST

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

Other Names:

Interpersonal Psychotherapy-Adolescent Skills Training

Active Comparator: Group Counseling

Group Counseling

Behavioral: Group Counseling

Usual group counseling as delivered by school counselors; 1 pre-group session, 1 mid-group session, 8 90-minute group sessions, 4 booster sessions

Other Names:

Usual group counseling

Outcome Measures

Primary Outcome Measures

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) [Post intervention (approximately 3 months post baseline)]
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation
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

Children's Depression Rating Scale-Revised (CDRS-R) [Post intervention (approximately 3 months after baseline)]
Scores on the CDRS-R
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) [Post intervention (approximately 3 months following baseline)]
Assesses global functioning
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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