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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201382
First Posted: September 14, 2010
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
Rutgers University
Information provided by (Responsible Party):
Jami Young, Children's Hospital of Philadelphia
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Depression Prevention Initiative - A Study of IPT-AST in School Settings

Further study details as provided by Jami Young, Children's Hospital of Philadelphia:

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) ]
    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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 185
Study Start Date: October 2010
Study Completion Date: June 2017
Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201382


Locations
United States, New Jersey
Rutgers University
Piscataway, New Jersey, United States, 08854
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute of Mental Health (NIMH)
Rutgers University
Investigators
Principal Investigator: Jami F Young, Ph.D. Children's Hospital of Philadelphia
  More Information

Responsible Party: Jami Young, Associate Professor, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01201382     History of Changes
Other Study ID Numbers: MH087481
R01MH087481 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2010
First Posted: September 14, 2010
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Jami Young, Children's Hospital of Philadelphia:
Depression
Prevention
Adolescents

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