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NCT Number: NCT01201382

Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University, Piscataway, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPT-AST

Behavioral

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 names: Interpersonal Psychotherapy-Adolescent Skills Training

Group counseling

Behavioral

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 names: Usual group counseling

Primary outcomes

  1. 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

  2. Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL

    Time frame: 6-months post-intervention

  3. Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL

    Time frame: 12-months post-intervention

  4. Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL

    Time frame: 18-months post-intervention

  5. Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL

    Time frame: 24-months post-intervention

Secondary outcomes

  1. Children's Depression Rating Scale-Revised (CDRS-R)

    Time frame: Post intervention (approximately 3 months after baseline)

    Scores on the CDRS-R

  2. Children's Depression Rating Scale-Revised

    Time frame: 6-months post-intervention

  3. Children's Depression Rating Scale-Revised

    Time frame: 12-months post-intervention

  4. Children's Depression Rating Scale-Revised

    Time frame: 18-months post-intervention

  5. Children's Depression Rating Scale-Revised

    Time frame: 24 months post-intervention

  6. Children's Global Assessment Scale (CGAS)

    Time frame: Post intervention (approximately 3 months following baseline)

    Assesses global functioning

  7. Children's Global Assessment Scale

    Time frame: 6-months post-intervention

  8. Children's Global Assessment Scale

    Time frame: 12-months post-intervention

  9. Children's Global Assessment Scale

    Time frame: 18-months post-intervention

  10. Children's Global Assessment Scale

    Time frame: 24-months post-intervention

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Rutgers University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
Sep 14, 2010
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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