Prevention of Depression in At-Risk Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Judy Garber, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00073671
First received: December 2, 2003
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Depression
Behavioral: Cognitive-behavioral prevention program
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Depression in At-Risk Adolescents

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of depression-free days [ Time Frame: Measured continuously through Month 33 ] [ Designated as safety issue: No ]

Enrollment: 316
Study Start Date: March 2003
Study Completion Date: January 2009
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants receive a group cognitive-behavioral prevention program
Behavioral: Cognitive-behavioral prevention program
Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.
Active Comparator: 2
Participants receive usual care
Other: Usual care
Participants receive usual care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073671

Locations
United States, Massachusetts
Harvard University Medical School
Boston, Massachusetts, United States, 02115-5794
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2593
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203-5721
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Judy Garber, PhD Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judy Garber, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00073671     History of Changes
Other Study ID Numbers: R01 MH64735, R01MH064735, DSIR 84-CTP
Study First Received: December 2, 2003
Last Updated: March 26, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
Adolescent

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014