NCT00461539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for phase_1 depression

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_1 depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 3, 2022

Status Verified

June 1, 2013

Enrollment Period

4.3 years

First QC Date

April 16, 2007

Last Update Submit

October 31, 2022

Conditions

DepressionAdolescent Health

Keywords

Tobacco UseAlcohol and Drug UseObesityRisky Sexual Behavior

Outcome Measures

Primary Outcomes (1)

  • Composite health risk behavior score

    Measured at Months 6 and 12

Secondary Outcomes (2)

  • Composite International Diagnostic Interview (CIDI) depression diagnosis

    Measured at Months 6 and 12

  • Satisfaction with care, as measured by the SF-12 health survey

    Measured at Months 6 and 12

Study Arms (2)

2

ACTIVE COMPARATOR

Participants will receive treatment as usual

Other: Treatment as usual

1

EXPERIMENTAL

Participants will receive the behavioral health intervention

Behavioral: Behavioral health intervention

Interventions

Treatment as usualOTHER

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

2
Behavioral health interventionBEHAVIORAL

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.

1

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • CIDI diagnosis of major depression or probable depression based on youth self report
  • Availability of a family member to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Los Angeles, California, 90024, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Related Publications (2)

  • 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.

    PMID: 30016473BACKGROUND

  • 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.

    PMID: 25309826BACKGROUND

MeSH Terms

Conditions

DepressionTobacco UseObesity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joan Asarnow, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry & Biobehavioral Sciences

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 18, 2007

Study Start

October 1, 2007

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 3, 2022

Record last verified: 2013-06

Locations

US(2)