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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jami Young, Rutgers University
ClinicalTrials.gov Identifier:
NCT01201382
First received: September 13, 2010
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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 Intervention
Depression
Behavioral: IPT-AST
Behavioral: Group Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Depression Prevention Initiative - A Study of IPT-AST in School Settings

Resource links provided by NLM:


Further study details as provided by Rutgers University:

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) [ Time Frame: Post intervention (approximately 3 months post baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
  • Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
  • Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL [ Time Frame: 18-months post-intervention ] [ Designated as safety issue: No ]
  • Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL [ Time Frame: 24-months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Post intervention (approximately 3 months after baseline) ] [ Designated as safety issue: No ]
    Scores on the CDRS-R

  • Children's Depression Rating Scale-Revised [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale-Revised [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale-Revised [ Time Frame: 18-months post-intervention ] [ Designated as safety issue: No ]
  • Children's Depression Rating Scale-Revised [ Time Frame: 24 months post-intervention ] [ Designated as safety issue: No ]
  • Children's Global Assessment Scale (CGAS) [ Time Frame: Post intervention (approximately 3 months following baseline) ] [ Designated as safety issue: No ]
    Assesses global functioning

  • Children's Global Assessment Scale [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
  • Children's Global Assessment Scale [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
  • Children's Global Assessment Scale [ Time Frame: 18-months post-intervention ] [ Designated as safety issue: No ]
  • Children's Global Assessment Scale [ Time Frame: 24-months post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Usual group counseling

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201382

Locations
United States, New Jersey
Rutgers University
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Jami F Young, Ph.D. Rutgers University
  More Information

No publications provided

Responsible Party: Jami Young, Associate Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT01201382     History of Changes
Other Study ID Numbers: MH087481, R01MH087481
Study First Received: September 13, 2010
Last Updated: September 17, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Rutgers University:
Depression
Prevention
Adolescents

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014