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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: IPT-AST; Behavioral: Group Counseling

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Rutgers University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: National Institute of Mental Health (NIMH); Rutgers University
• Investigators: Principal Investigator: Jami F Young, Ph.D., Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Adolescents; Depression; Prevention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: MH087481; R01MH087481 (U.S. NIH Grant/Contract)