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History of Changes for Study: NCT02188797
Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless Youth
Latest version (submitted April 15, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 10, 2014 None (earliest Version on record)
2 August 1, 2014 Study Description, Study Status and Study Identification
3 May 5, 2015 Study Status and Study Design
4 April 15, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT02188797
Submitted Date:  July 10, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: R34DA034813
Brief Title: Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless Youth
Official Title: Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2014
Overall Status: Recruiting
Study Start: January 2014
Primary Completion: July 2015 [Anticipated]
Study Completion: April 2016 [Anticipated]
First Submitted: July 10, 2014
First Submitted that
Met QC Criteria:
July 10, 2014
First Posted: July 14, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 10, 2014
Last Update Posted: July 14, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: RAND
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The goal of this study is to evaluate a group-based MI-delivered risk reduction program for homeless young adults. It is hypothesized that youth who participate in the program will show greater reductions in substance use intentions, behavior and consequences, as well as sexual activity intentions and risk behavior, over a 3-month period compared to a usual care control sample of youth who do not participate in the program.
Detailed Description:

This study addresses an important gap in prevention services for homeless youth by conducting a pilot test of an innovative 4-session integrated AOD and sexual risk reduction program for this population that is feasible to deliver in settings where these youth seek services. The study has 2 specific aims:

Aim 1: Investigate whether homeless youth who participate in the program show reductions in AOD use intentions, behavior and consequences, as well as sexual activity intentions and risk behavior, over a 3-month period compared to a usual care control sample of youth who do not receive the program.

Aim 2: Gain a better understanding of intervention effects by exploring whether improvements in self-efficacy, readiness to change, outcome expectancies, and exposure to peer substance use and offers serve as explanatory mechanisms for reductions in AOD- and sexual activity- related intentions and risk behaviors among youth who participate in the program.

The program will be evaluated using a form of group-randomized design, although with crossover of conditions and groups to avoid the problems of power reduction associated with conventional group randomization. The unit of analysis will be the individual, but individuals will be assigned to groups based on the agency where they are seeking services. Youth at two drop-in centers serving homeless youth will either be in the intervention condition or a "usual care" control condition. The field period will be divided into four phases. The two agencies will alternate across phases in serving as the "intervention site" or "control site," with each agency having a total of two intervention phases and two control phases.

Intervention Condition: We will be pilot testing a four-session voluntary intervention that is delivered within a drop-in center setting and is based on our previous intervention work with adolescents and young adults. Each session lasts approximately 1 hour. The intervention focuses on both sexual risk behavior and AOD use. Although some sessions focus more heavily on sexual risk and others on AOD use, each session includes content that emphasizes the interrelated nature of these two risk behaviors. In all sessions, participants will receive a personalized feedback sheet that specifically addresses a topic being discussed during that particular session. An MI approach will be used to present material during the group sessions.

"Usual Care" Condition: Our "usual care" condition reflects the resources typically available in settings that serve homeless youth: an HIV informational brochure that discusses the connection between AOD use and HIV risk, and a Community Resource Guide that lists free or low-cost AOD and HIV-related services.

Open or close this module Conditions
Conditions: Substance Use
Sexual Risk Behavior
Keywords: homeless
young adults
substance use
HIV risk
sexual risk behavior
group motivational interviewing
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 168 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group MI risk reduction program
Participants receive four 1-hour group motivational interviewing sessions focused on reducing substance use and sexual risk behavior. They also receive an HIV information brochure and Community Resource Guide.
Behavioral: Group MI risk reduction program
No Intervention: Usual care control
Participant receive HIV information brochure and Community Resource Guide.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in substance use
[ Time Frame: baseline, 3 months ]

past month quantity-frequency of alcohol and marijuana; past 3 months frequency of alcohol, binge drinking, marijuana, crack, cocaine, heroin, methamphetamine, ecstasy, hallucinogens, inhalants, prescription drug misuse
2. Change in substance use intentions
[ Time Frame: baseline, 3 months ]

Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs
3. Change in negative consequences from drinking
[ Time Frame: baseline, 3 months ]

4. Change in use of drinking protective strategies
[ Time Frame: baseline, 3 months ]

5. Change in number of different sex partners
[ Time Frame: baseline, 3 months ]

6. Change in condom use
[ Time Frame: baseline, 3 months ]

7. Change in substance use before or during sex
[ Time Frame: baseline, 3 months ]

8. Change in HIV knowledge
[ Time Frame: baseline, 3 months ]

9. Change in sex-related protective strategies
[ Time Frame: baseline, 3 months ]

10. Change in sexual intentions
[ Time Frame: baseline, 3 months ]

Separate items for intentions for buying/getting condoms, carrying condoms, talking to partner about condoms, using condoms, using condoms when drinking or using drugs, getting tested
11. Change in HIV testing
[ Time Frame: baseline, 3 months ]

Self-report of being tested in lifetime, past 3 months
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 24 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • between 18-24 years, receiving services at one of the participating drop-in centers, planning to be in the study area for the next month

Exclusion Criteria:

  • obvious cognitive impairment observed during screening process; non-English speaking
Open or close this module Contacts/Locations
Central Contact Person: Joan Tucker, PhD
Telephone: 310-393-0411 Ext. 7519
Email: jtucker@rand.org
Locations: United States, California
My Friend's Place
[Recruiting]
Hollywood, California, United States
Contact:Contact: Heather Carmichael 323-908-0011
Safe Place for Youth
[Recruiting]
Venice Beach, California, United States, 90291
Contact:Contact: Alison Hurst 562-230-0540
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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