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Clinical Trials/NCT01201382
NCT01201382
Completed
Not Applicable

Depression Prevention Initiative - A Study of IPT-AST in School Settings

Children's Hospital of Philadelphia2 sites in 1 country185 target enrollmentOctober 2010
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Children's Hospital of Philadelphia
Enrollment
185
Locations
2
Primary Endpoint
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)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
June 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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: 24-months post-intervention

Secondary Outcomes

  • Children's Depression Rating Scale-Revised (CDRS-R)(Post intervention (approximately 3 months after baseline))
  • Children's Depression Rating Scale-Revised(24 months post-intervention)
  • Children's Global Assessment Scale (CGAS)(Post intervention (approximately 3 months following baseline))
  • Children's Global Assessment Scale(24-months post-intervention)

Study Sites (2)

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