Reducing Health Risk Behavior and Improving Health in Adolescents With Depression
Primary Purpose
Depression, Adolescent Health
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment as usual
Behavioral health intervention
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Tobacco Use, Alcohol and Drug Use, Obesity, Risky Sexual Behavior
Eligibility 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
Sites / Locations
- University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior
- Kaiser Permanente Los Angeles Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
2
1
Arm Description
Participants will receive treatment as usual
Participants will receive the behavioral health intervention
Outcomes
Primary Outcome Measures
Composite health risk behavior score
Secondary Outcome Measures
Composite International Diagnostic Interview (CIDI) depression diagnosis
Satisfaction with care, as measured by the SF-12 health survey
Full Information
NCT ID
NCT00461539
First Posted
April 16, 2007
Last Updated
October 31, 2022
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH), Kaiser Permanente Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00461539
Brief Title
Reducing Health Risk Behavior and Improving Health in Adolescents With Depression
Official Title
Reducing Health Risk Behavior and Improving Health in Adolescent Depression
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH), Kaiser Permanente Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Adolescent Health
Keywords
Tobacco Use, Alcohol and Drug Use, Obesity, Risky Sexual Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive the behavioral health intervention
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral health intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite health risk behavior score
Time Frame
Measured at Months 6 and 12
Secondary Outcome Measure Information:
Title
Composite International Diagnostic Interview (CIDI) depression diagnosis
Time Frame
Measured at Months 6 and 12
Title
Satisfaction with care, as measured by the SF-12 health survey
Time Frame
Measured at Months 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Asarnow, PhD
Organizational Affiliation
University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30016473
Citation
Bai S, Zeledon LR, D'Amico EJ, Shoptaw S, Avina C, LaBorde AP, Anderson M, Fitzpatrick OM, Asarnow JR. Reducing Health Risk Behaviors and Improving Depression in Adolescents: A Randomized Controlled Trial in Primary Care Clinics. J Pediatr Psychol. 2018 Oct 1;43(9):1004-1016. doi: 10.1093/jpepsy/jsy048.
Results Reference
background
PubMed Identifier
25309826
Citation
Asarnow JR, Zeledon LR, D'Amico E, LaBorde A, Anderson M, Avina C, Arslanian T, Do MC, Harwood J, Shoptaw S. Depression and Health Risk Behaviors: Towards Optimizing Primary Care Service Strategies for Addressing Risk. Prim Health Care. 2014 Mar 1;4(1):152. doi: 10.4172/2167-1079.1000152.
Results Reference
background
Learn more about this trial
Reducing Health Risk Behavior and Improving Health in Adolescents With Depression
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