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

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ClinicalTrials.gov Identifier: NCT01201382
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : August 28, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Rutgers University
Information provided by (Responsible Party):
Jami Young, Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE September 13, 2010
First Posted Date  ICMJE September 14, 2010
Last Update Posted Date August 28, 2017
Study Start Date  ICMJE October 2010
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • 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) ]
    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 ]
  • Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL [ Time Frame: 12-months post-intervention ]
  • Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL [ Time Frame: 18-months post-intervention ]
  • Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL [ Time Frame: 24-months post-intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01201382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2010)
  • Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Post intervention (approximately 3 months after baseline) ]
    Scores on the CDRS-R
  • Children's Depression Rating Scale-Revised [ Time Frame: 6-months post-intervention ]
  • Children's Depression Rating Scale-Revised [ Time Frame: 12-months post-intervention ]
  • Children's Depression Rating Scale-Revised [ Time Frame: 18-months post-intervention ]
  • Children's Depression Rating Scale-Revised [ Time Frame: 24 months post-intervention ]
  • Children's Global Assessment Scale (CGAS) [ Time Frame: Post intervention (approximately 3 months following baseline) ]
    Assesses global functioning
  • Children's Global Assessment Scale [ Time Frame: 6-months post-intervention ]
  • Children's Global Assessment Scale [ Time Frame: 12-months post-intervention ]
  • Children's Global Assessment Scale [ Time Frame: 18-months post-intervention ]
  • Children's Global Assessment Scale [ Time Frame: 24-months post-intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings
Official Title  ICMJE Depression Prevention Initiative - A Study of IPT-AST in School Settings
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: IPT-AST
    Interpersonal Psychotherapy-Adolescent Skills Training
    Intervention: Behavioral: IPT-AST
  • Active Comparator: Group Counseling
    Group Counseling
    Intervention: Behavioral: Group Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2017)
185
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2010)
200
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01201382
Other Study ID Numbers  ICMJE MH087481
R01MH087481 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jami Young, Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • Rutgers University
Investigators  ICMJE
Principal Investigator: Jami F Young, Ph.D. Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date August 2017

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