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CompletedNCT01201382Updated Apr 8, 2021

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

An interventional study of IPT-AST and Group Counseling in Depression, sponsored by Children's Hospital of Philadelphia. Completed at 2 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-04-08.

Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
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Study 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.

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Conditions studied

  • Depression

Keywords

  • Depression
  • Prevention
  • Adolescents
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In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 185 is above the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    IPT-AST

    Interpersonal Psychotherapy-Adolescent Skills Training

    Behavioral: IPT-AST

  • Active comparator
    Group Counseling

    Group Counseling

    Behavioral: Group Counseling

Interventions

  • BehavioralIPT-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

    Also known as: Interpersonal Psychotherapy-Adolescent Skills Training

  • BehavioralGroup 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

    Also known as: Usual group counseling

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What researchers measure

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)

    Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation

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

  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)

    Scores on the CDRS-R

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

  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)

    Assesses global functioning

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

  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

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Study locations

2 sites
  • Rutgers University
    Piscataway, New Jersey 08854, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19146, United States
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References and documents

Study documents

  • Informed consent form · Apr 11, 2011

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01201382
Lead sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH), Rutgers University
Responsible party
Sponsor
First posted
Sep 14, 2010
Start date
Oct 2010
Primary completion
Jun 2015
Completion
Jun 2017
Last update
Apr 8, 2021

Study contacts

Jami F Young, Ph.D.
principal investigator · Children's Hospital of Philadelphia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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