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

NCT01201382 | Completed DMC

• 2 other identifiers: MH087481R01MH087481
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Keywords

Depression; Prevention; Adolescents

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Children's Depression Rating Scale-Revised (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

Study Arms (2)

IPT-AST

EXPERIMENTAL

Interpersonal Psychotherapy-Adolescent Skills Training

Behavioral: IPT-AST

Group Counseling

ACTIVE COMPARATOR

Group Counseling

Behavioral: Group Counseling

Interventions

IPT-AST BEHAVIORAL

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

Also known as: Interpersonal Psychotherapy-Adolescent Skills Training

IPT-AST

Group Counseling BEHAVIORAL

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

Also known as: Usual group counseling

Group Counseling

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator
• Rutgers University: collaborator

Study Sites (2)

Rutgers University

Piscataway, New Jersey, 08854, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jami F Young, Ph.D.

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2017
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (2)