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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00862238
Other study ID # 081101501
Secondary ID 1R21DA023521
Status Completed
Phase Phase 2
First received March 13, 2009
Last updated March 21, 2013
Start date April 2008
Est. completion date March 2011

Study information

Verified date March 2013
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

In the study, homeless youth from a drop-in site and faculty from UCLA and California Institute of the Arts will develop, pilot test and evaluate a youth-based drug and health-promoting program. It is hoped that this program will help in the development of a program that can be further tested in a larger study and lead to the development of an innovative and effective drug counseling program that youth situated in homeless sites will utilize.


Description:

Nationwide, homeless youths are attempting to escape major life challenges, which may result in problem drug and alcohol use. Such behaviors are associated with hepatitis virus infections and HIV. Less than one third of homeless youth seek medical care, and less than 10% of drug and alcohol-using youths seek substance abuse treatment services. Based upon increasing knowledge about the barriers experienced by homeless youth relating to accessing treatment for substance use and health promoting services, it is clear that homeless youth need to play a major role in the planning, implementation and evaluation of drug counseling programs delivered at sites that homeless youth frequent. Using a community-based participatory research (CBPR) approach, UCLA researchers recently engaged homeless youth and community partners in qualitative research to better understand homeless youths' perspectives on drug counseling and to consider innovative strategies to engage homeless youth, in accessing drug use and health promotion counseling. Our community partners included homeless youth from homeless youth-based organizations, and faculty from the California Institute of the Arts (CalArts). An innovative youth-centered strategy considered by homeless youth was the use of the arts and media to craft personal messages that capture youth interest and appeal. In the proposed investigation, researchers, homeless youth and staff from a drop-in site frequented by homeless youth, along with our CalArts partners, will participate in the development, pilot testing and evaluation of a youth-centered drug-use and health-promoting intervention program. In Phase I of this R21, a CBPR approach will be utilized with a steering committee to develop a youth-centered drug use and health promoting intervention program, LIFE MATTERS which will be assessed in terms of acceptability via focus group sessions with street youth and subsequently refined based upon homeless youth feedback. In Phase 2, investigators and community partners will conduct a pilot study to explore the acceptability of the LIFE MATTERS program as well as test the impact of the program, compared to a control group, with 80 similar youth in terms of: completion of the program; reduction of risky drug and alcohol use; completion of a HAV/HBV vaccine series; and improvement in knowledge about hepatitis. The short-term goals are to refine strategies that can be fully tested in a large-scale intervention trial. The long-term goals are to contribute to knowledge about promoting innovative and youth-designed drug-related behaviors, and treatment completion in settings where youth congregate.


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 24 Years
Eligibility Inclusion Criteria:

- Inclusion criteria for this Phase II study of 128 homeless youth recruited from Common Ground (described in Phase I) include:

1. unsheltered homeless, 15-24 years of age, and frequenting the study site;

2. screened as a moderate-to-heavy drug user;

3. willing to be tested for HAV/HBV at baseline; and

4. not a participant of the Phase I study.

Exclusion Criteria:

- Cognitively impaired and not a participant of Phase I.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Art Messaging
4-session educational group which utilizes art, photography, film, painting to portray a message to reduce drug use, and prevent hepatitis A, B, & C
Other:
Health Promotion
4 session education which offers basic information about the prevention of hepatitis A, B, & C

Locations

Country Name City State
United States Common Ground Santa Monica California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Conduct a pilot study to explore the acceptability of the LIFE-MATTERS program, and estimate the impact of the program, compared to the control group. 2 years No
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