Reducing Health Risk Behavior and Improving Health in Adolescents With Depression

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT00461539

Collaborator

National Institute of Mental Health (NIMH) (NIH)

217

Enrollment

Locations

Arms

Duration (Months)

108.5

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

217 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Reducing Health Risk Behavior and Improving Health in Adolescent Depression

Study Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Composite health risk behavior score [Measured at Months 6 and 12]

Secondary Outcome Measures

Composite International Diagnostic Interview (CIDI) depression diagnosis [Measured at Months 6 and 12]
Satisfaction with care, as measured by the SF-12 health survey [Measured at Months 6 and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior	Los Angeles	California	United States	90024
2	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	United States	90027