Substance Use and Sexual Risk Reduction Intervention for Homeless Youth

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by RAND
Sponsor:
Information provided by (Responsible Party):
RAND
ClinicalTrials.gov Identifier:
NCT02188797
First received: July 10, 2014
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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 Intervention
Substance Use
Sexual Risk Behavior
Behavioral: Group MI risk reduction program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless

Resource links provided by NLM:


Further study details as provided by RAND:

Primary Outcome Measures:
  • Change in substance use [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    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

  • Change in substance use intentions [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs

  • Change in negative consequences from drinking [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
  • Change in use of drinking protective strategies [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
  • Change in number of different sex partners [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
  • Change in condom use [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
  • Change in substance use before or during sex [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
  • Change in HIV knowledge [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
  • Change in sex-related protective strategies [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
  • Change in sexual intentions [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    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

  • Change in HIV testing [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    Self-report of being tested in lifetime, past 3 months


Estimated Enrollment: 168
Study Start Date: January 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02188797

Contacts
Contact: Joan Tucker, PhD 310-393-0411 ext 7519 jtucker@rand.org

Locations
United States, California
My Friend's Place Recruiting
Hollywood, California, United States
Contact: Heather Carmichael    323-908-0011      
Safe Place for Youth Recruiting
Venice Beach, California, United States, 90291
Contact: Alison Hurst    562-230-0540      
Sponsors and Collaborators
RAND
  More Information

No publications provided

Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT02188797     History of Changes
Other Study ID Numbers: R34DA034813
Study First Received: July 10, 2014
Last Updated: August 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by RAND:
homeless
young adults
substance use
HIV risk
sexual risk behavior
group motivational interviewing

ClinicalTrials.gov processed this record on October 29, 2014