Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings
This study is currently recruiting participants.
Verified July 2011 by Rutgers University
Sponsor:
Rutgers University
Collaborator:
Information provided by:
Rutgers University
ClinicalTrials.gov Identifier:
NCT01201382
First received: September 13, 2010
Last updated: July 19, 2011
Last verified: July 2011
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Depression Prevention Initiative - A Study of IPT-AST in School Settings |
Resource links provided by NLM:
Further study details as provided by Rutgers University:
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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
- Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL [ Time Frame: 18-months post-intervention ] [ Designated as safety issue: No ]
- Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL [ Time Frame: 24-months post-intervention ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: Post intervention (approximately 3 months after baseline) ] [ Designated as safety issue: No ]Scores on the CDRS-R
- Children's Depression Rating Scale-Revised [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
- Children's Depression Rating Scale-Revised [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
- Children's Depression Rating Scale-Revised [ Time Frame: 18-months post-intervention ] [ Designated as safety issue: No ]
- Children's Depression Rating Scale-Revised [ Time Frame: 24 months post-intervention ] [ Designated as safety issue: No ]
- Children's Global Assessment Scale (CGAS) [ Time Frame: Post intervention (approximately 3 months following baseline) ] [ Designated as safety issue: No ]Assesses global functioning
- Children's Global Assessment Scale [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
- Children's Global Assessment Scale [ Time Frame: 12-months post-intervention ] [ Designated as safety issue: No ]
- Children's Global Assessment Scale [ Time Frame: 18-months post-intervention ] [ Designated as safety issue: No ]
- Children's Global Assessment Scale [ Time Frame: 24-months post-intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (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| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201382
Contacts
| Contact: Jami F Young, Ph.D. | 848-445-3934 | jfyoung@rci.rutgers.edu |
Locations
| United States, New Jersey | |
| Rutgers University | Recruiting |
| Piscataway, New Jersey, United States, 08854 | |
| Principal Investigator: Jami F Young, Ph.D. | |
Sponsors and Collaborators
Rutgers University
Investigators
| Principal Investigator: | Jami F Young, Ph.D. | Rutgers University |
More Information
No publications provided
| Responsible Party: | Jami Young, Rutgers University |
| ClinicalTrials.gov Identifier: | NCT01201382 History of Changes |
| Other Study ID Numbers: | MH087481, R01MH087481 |
| Study First Received: | September 13, 2010 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Rutgers University:
|
Depression Prevention Adolescents |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013