Reducing Health Risk Behavior and Improving Health in Adolescents With Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joan Asarnow, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00461539
First received: April 16, 2007
Last updated: June 5, 2013
Last verified: June 2013

April 16, 2007
June 5, 2013
October 2007
January 2012   (final data collection date for primary outcome measure)
Composite health risk behavior score [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
Composite health risk behavior score (measured 6 and 12 months following study entry)
Complete list of historical versions of study NCT00461539 on ClinicalTrials.gov Archive Site
  • Composite International Diagnostic Interview (CIDI) depression diagnosis [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Satisfaction with care, as measured by the SF-12 health survey [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Composite International Diagnostic Interview (CIDI) depression diagnosis
  • satisfaction with care, as measured by the SF-12 health survey (all measured 6 and 12 months following study entry)
Not Provided
Not Provided
 
Reducing Health Risk Behavior and Improving Health in Adolescents With Depression
Reducing Health Risk Behavior and Improving Health in Adolescent Depression

This study will determine the effectiveness of a health education intervention in reducing health risk behavior and improving health in adolescents with depression.

Depression is a common disorder among adolescents. If left untreated, it can cause significant disability, illness, and even death. Teens with depression often engage in risky health behaviors, such as smoking, drug and alcohol use, unprotected sex, and unhealthy eating and exercise patterns. By reducing these health risk behaviors, depressed adolescents may be able to avoid negative health consequences and improve their physical and mental health. This study will determine the effectiveness of a health education intervention in reducing risky health behaviors in adolescents with depression.

Participants in this study will be invited to enroll during a visit to a participating primary care clinic. Participants will be randomly assigned to either partake in a health education intervention or receive standard care. Both groups will continue to receive treatment through their primary care clinic. Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors. Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention. The intervention will be tailored to target the specific risky behaviors in which each participant engages. Motivational interviewing will also be used to build positive attitudes to support behavior change. All participants will attend follow-up visits to assess behavior change at Months 6 and 12 following study entry.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Adolescent Health
  • Other: Treatment as usual
    Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors.
  • Behavioral: Behavioral health intervention
    Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention.
  • Active Comparator: 2
    Participants will receive treatment as usual
    Intervention: Other: Treatment as usual
  • Experimental: 1
    Participants will receive the behavioral health intervention
    Intervention: Behavioral: Behavioral health intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
217
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • CIDI diagnosis of major depression or probable depression based on youth self report
  • Availability of a family member to provide informed consent

Exclusion Criteria:

  • Lacks contact information (e.g., address, telephone number)
  • Any functioning deficits or other characteristics that might interfere with study participation
  • Currently in a living situation that might interfere with study participation (e.g., lives over 1 hour away from the study site)
  • Lacks family available to participate in the intervention
  • Mental retardation
  • Does not speak English or Spanish
Both
13 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00461539
R01 MH078596, R01MH078596, DAHBR 96-BHB
Yes
Joan Asarnow, University of California, Los Angeles
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Principal Investigator: Joan Asarnow, PhD University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior
University of California, Los Angeles
June 2013

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