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

September 13, 2010
September 17, 2013
October 2010
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01201382 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Depression
  • 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
  • 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
  • Experimental: IPT-AST
    Interpersonal Psychotherapy-Adolescent Skills Training
    Intervention: Behavioral: IPT-AST
  • Active Comparator: Group Counseling
    Group Counseling
    Intervention: Behavioral: Group Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01201382
MH087481, R01MH087481
Yes
Jami Young, Rutgers University
Rutgers University
National Institute of Mental Health (NIMH)
Principal Investigator: Jami F Young, Ph.D. Rutgers University
Rutgers University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP