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: July 11, 2014
Last verified: July 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 11, 2014
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
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 21, 2014