Reducing Health Risk Behavior and Improving Health in Adolescents With Depression

Depression Clinical Trial

Official title:

Reducing Health Risk Behavior and Improving Health in Adolescent Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461539
• Other study ID #: R01MH078596
• Secondary ID: R01MH078596DAHBR
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 2007
• Est. completion date: January 2012

Study information

• Verified date: June 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Health
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Kaiser Permanente Research Foundation, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite health risk behavior score		Measured at Months 6 and 12
Secondary	Composite International Diagnostic Interview (CIDI) depression diagnosis		Measured at Months 6 and 12
Secondary	Satisfaction with care, as measured by the SF-12 health survey		Measured at Months 6 and 12