Drug UsePhase 2NCT00862238
An Arts Intervention for Drug-Using Homeless Youth
A Phase 2 study testing Art Messaging and Health Promotion in people with Drug Use, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Use
- What is being tested?
- Art Messaging and Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Cognitively impaired and not a participant of Phase I.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Drug Use
- Being tested
- Art Messaging, Health Promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art MessagingBehavioural
4-session educational group which utilizes art, photography, film, painting to portray a message to reduce drug use, and prevent hepatitis A, B, \& C
Health PromotionOther
4 session education which offers basic information about the prevention of hepatitis A, B, \& C
| Study group | Role | What they receive |
|---|---|---|
| Art Messaging | Experimental | 4-session educational group which utilizes art, photography, film, painting to portray a message to reduce drug use, and prevent hepatitis A, B, \& C Receives: Behavioral: Art Messaging |
| Health Promotion | Other | 4-session education offering basic information about the prevention of hepatitis A, B \& C Receives: Other: Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startApr 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Adeline Nyamathi, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862238
- Sponsor's protocol ID
- 081101501
- Other IDs
- 1R21DA023521
- Status last verified
- Mar 2013
- First submitted
- 13 Mar 2009
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Arts Intervention for Drug-Using Homeless Youth
- ClinicalTrials.gov ID
- NCT00862238
- Acronym / sponsor ID
- 081101501
- Conditions
- Drug Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Messaging | Experimental | Behavioral: Art Messaging4-session educational group which utilizes art, photography, film, painting to portray a message to reduce drug use, and prevent hepatitis A, B, \& C |
| Health Promotion | Other | Other: Health Promotion4-session education offering basic information about the prevention of hepatitis A, B \& C |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Inclusion criteria for this Phase II study of 128 homeless youth recruited from Common Ground (described in Phase I) include:
Key exclusion criteria (1 listed)
- Cognitively impaired and not a participant of Phase I.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art Messaging4-session educational group which utilizes art, photography, film, painting to portray a message to reduce drug use, and prevent hepatitis A, B, \& C | Behavioural | Art Messaging |
| Health Promotion4 session education which offers basic information about the prevention of hepatitis A, B, \& C | Other | Health Promotion |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Art Messaging and Health Promotion in people with Drug Use, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013.