- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00862238
An Arts Intervention for Drug-Using Homeless Youth
March 21, 2013 updated by: Adeline Nyamathi, MD, University of California, Los Angeles
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Santa Monica, California, United States, 90405
- Common Ground
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Inclusion criteria for this Phase II study of 128 homeless youth recruited from Common Ground (described in Phase I) include:
- unsheltered homeless, 15-24 years of age, and frequenting the study site;
- screened as a moderate-to-heavy drug user;
- willing to be tested for HAV/HBV at baseline; and
- not a participant of the Phase I study.
Exclusion Criteria:
- Cognitively impaired and not a participant of Phase I.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
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 offering basic information about the prevention of hepatitis A, B & C
|
4 session education which offers basic information about the prevention of hepatitis A, B, & C
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
March 13, 2009
First Submitted That Met QC Criteria
March 13, 2009
First Posted (Estimate)
March 16, 2009
Study Record Updates
Last Update Posted (Estimate)
March 25, 2013
Last Update Submitted That Met QC Criteria
March 21, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 081101501
- 1R21DA023521 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.