Clinical trial NCT00461539: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depression
Adolescent Health
Keywords: Tobacco Use
Alcohol and Drug Use
Obesity
Risky Sexual Behavior
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Kaiser Permanente Research Foundation
First posted: 2007-04-18
Enrollment: 217
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Composite health risk behavior score
timeFrame: Measured at Months 6 and 12
Secondary outcomes:
measure: Composite International Diagnostic Interview (CIDI) depression diagnosis
timeFrame: Measured at Months 6 and 12
measure: Satisfaction with care, as measured by the SF-12 health survey
timeFrame: Measured at Months 6 and 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior
name: Joan Asarnow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.