Reducing Health Risk Behavior and Improving Health in Adolescents With Depression

NCT ID: NCT00461539

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Adolescent Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

Participants will receive treatment as usual

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type OTHER

Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors.

1

Participants will receive the behavioral health intervention

Group Type EXPERIMENTAL

Behavioral health intervention

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Treatment as usual

Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Kaiser Permanente Research Foundation

UNKNOWN

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joan Asarnow

Professor of Psychiatry & Biobehavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joan Asarnow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30016473 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25309826 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01MH078596

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DAHBR 96-BHB

Identifier Type: -

Identifier Source: secondary_id

R01MH078596

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Adolescence and Depression
NCT00523081 COMPLETED PHASE3
Skills for Wellness
NCT01980147 RECRUITING NA
Depression Management Project
NCT01150604 COMPLETED NA
Depression Outcomes Study of Exercise
NCT00964054 COMPLETED PHASE1