ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Reducing Health Risk Behavior and Improving Health in Adolescents With Depression

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00461539
  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 I
Phase II

MedlinePlus related topics:   Depression    Obesity    Obesity in Children   

ChemIDplus related topics:   Ethanol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Reducing Health Risk Behavior and Improving Health in Adolescent Depression

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:   350
Study Start Date:   October 2007
Estimated Study Completion Date:   April 2011
Estimated Primary Completion Date:   March 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
2: Active Comparator
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.
1: Experimental
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461539

Contacts
Contact: Joan Asarnow, PhD     310-825-0408     jasarnow@mednet.ucla.edu    
Contact: Ancy E. Cherian, PhD     310-794-4962     acherian@mednet.ucla.edu    

Locations
United States, California
University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior     Recruiting
      Los Angeles, California, United States, 90024
      Contact: Daniel Cohen, BA     310-794-4962     drcohen@mednet.ucla.edu    
      Principal Investigator: Joan Asarnow, PhD            
Kaiser Permanente Los Angeles Medical Center     Not yet recruiting
      Los Angeles, California, United States, 90027
      Contact: Luis R. Zeledon, MD     323-783-4184     luis.r.zeledon@kp.org    
      Principal Investigator: Luis R. Zeledon, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Joan Asarnow, PhD     University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior    
  More Information

Responsible Party:   University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior ( Joan Asarnow, PhD )
Study ID Numbers:   R01 MH78596, DAHBR 96-BHB
First Received:   April 16, 2007
Last Updated:   August 26, 2008
ClinicalTrials.gov Identifier:   NCT00461539
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Tobacco Use  
Alcohol and Drug Use  
Obesity  
Risky Sexual Behavior  

Study placed in the following topic categories:
Obesity
Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Ethanol
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2008




Links to all studies - primarily for crawlers