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Prevention of Depression in At-Risk Adolescents

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Judith Garber, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00073671
First received: December 2, 2003
Last updated: April 7, 2017
Last verified: April 2017
December 2, 2003
April 7, 2017
March 2003
March 2006   (Final data collection date for primary outcome measure)
Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4) [ Time Frame: Measured continuously through month 33 ]
Not Provided
Complete list of historical versions of study NCT00073671 on ClinicalTrials.gov Archive Site
Number of depression-free days [ Time Frame: Measured continuously through Month 33 ]
Not Provided
Not Provided
Not Provided
 
Prevention of Depression in At-Risk Adolescents
Prevention of Depression in At-Risk Adolescents
This study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression.

Depression is a prevalent, chronic, and impairing condition that is often undetected and becomes more difficult to treat as chronicity increases. There is an increasing need to conduct large-scale depression prevention studies in adolescents. This study evaluates a cognitive-behavioral prevention (CBP) program to determine its effectiveness in preventing depressive disorders in at-risk adolescents. The study also will ascertain the costs this intervention to inform attempts at future dissemination of the program in "real world" settings.

Participants in this study are randomly assigned to receive either CBP for eight weekly and 6 monthly continuation sessions or usual care. Depressive symptoms and disorders, levels of functioning, and medical and mental health care utilization are assessed at baseline and again at 2, 8, 20, and 32 months after intake.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Outcome assessor were unaware of condition assignment
Primary Purpose: Prevention
Depression
  • Behavioral: Cognitive-behavioral prevention program
    Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.
  • Other: Usual care
    Participants receive usual care
  • Experimental: 1
    Participants receive a group cognitive-behavioral prevention program
    Intervention: Behavioral: Cognitive-behavioral prevention program
  • Active Comparator: 2
    Participants receive usual care
    Intervention: Other: Usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
316
January 2009
March 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A parent has had a depressive disorder during child's life
  • Adolescent has had a past depressive episode or has current subsyndromal depressive symptoms measured on the Center for Epidemiological Studies Depression Scale (CES-D)

Exclusion Criteria:

  • adolescent or parent ever diagnosed with bipolar I or schizophrenia;
  • adolescent has a current DSM-IV mood disorder diagnosis
Sexes Eligible for Study: All
13 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00073671
R01MH064735( U.S. NIH Grant/Contract )
R01MH064735 ( U.S. NIH Grant/Contract )
DSIR 84-CTP
Yes
Not Provided
Not Provided
Judith Garber, Vanderbilt University Medical Center
Vanderbilt University
National Institute of Mental Health (NIMH)
Principal Investigator: Judy Garber, PhD Vanderbilt University
Vanderbilt University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP