Substance Use and Sexual Risk Reduction Intervention for Homeless Youth

• ClinicalTrials.gov Identifier: NCT02188797
• Recruitment Status: Completed
• First Posted: July 14, 2014
• Last Update Posted: April 19, 2016
• Sponsor: RAND
• Information provided by (Responsible Party): RAND

Study Description

Brief Summary:

The goal of this study is to evaluate a group-based motivational interviewing (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.

Condition or disease	Intervention/treatment	Phase
Substance Use; Sexual Risk Behavior	Behavioral: Group MI risk reduction program	Not Applicable

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 substance use 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 substance use and 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 substance use- 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: This condition involves a four-session voluntary intervention that is delivered within a drop-in center setting and is based on the investigator's previous intervention work with adolescents and young adults. Each session lasts approximately 1 hour. The intervention focuses on both sexual risk behavior and substance use. Although some sessions focus more heavily on sexual risk and others on substance 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 motivational interviewing approach will be used to present material during the group sessions.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless
• Study Start Date: January 2014
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
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.

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 24 Years (Adult)
• Sexes Eligible for Study: All
• 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

Contacts and Locations

Locations

United States, California

My Friend's Place

Hollywood, California, United States

Safe Place for Youth

Venice Beach, California, United States, 90291

Sponsors and Collaborators

RAND

More Information

• Responsible Party: RAND
• ClinicalTrials.gov Identifier: NCT02188797
• Other Study ID Numbers: R34DA034813 ( U.S. NIH Grant/Contract )
• First Posted: July 14, 2014
• Last Update Posted: April 19, 2016
• Last Verified: April 2016

Keywords provided by RAND:

homeless; young adults; substance use; HIV risk; sexual risk behavior; group motivational interviewing