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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
  Purpose

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


Condition Intervention Phase
Depression
Adolescent Health
Other: Treatment as usual
Behavioral: Behavioral health intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Health Risk Behavior and Improving Health in Adolescent Depression

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Composite health risk behavior score [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 217
Study Start Date: October 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Participants will receive treatment as usual
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.
Experimental: 1
Participants will receive the behavioral health intervention
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00461539

Locations
United States, California
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Joan Asarnow, PhD University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior
  More Information

No publications provided

Responsible Party: Joan Asarnow, Professor of Psychiatry & Biobehavioral Sciences, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00461539     History of Changes
Other Study ID Numbers: R01 MH078596, R01MH078596, DAHBR 96-BHB
Study First Received: April 16, 2007
Last Updated: June 5, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Tobacco Use
Alcohol and Drug Use
Obesity
Risky Sexual Behavior

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

ClinicalTrials.gov processed this record on November 25, 2014