Substance Use and Sexual Risk Reduction Intervention for Homeless Youth

Substance Use Clinical Trial

Official title:

Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188797
• Other study ID #: R34DA034813
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: April 15, 2016
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: April 2016
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 24 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sexual Risk Behavior
• Substance Use

Intervention

Behavioral:
• Group MI risk reduction program

Locations

Country	Name	City	State
United States	My Friend's Place	Hollywood	California
United States	Safe Place for Youth	Venice Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
RAND

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in substance use	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	baseline, 3 months	No
Primary	Change in substance use intentions	Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs	baseline, 3 months	No
Primary	Change in negative consequences from drinking		baseline, 3 months	No
Primary	Change in use of drinking protective strategies		baseline, 3 months	No
Primary	Change in number of different sex partners		baseline, 3 months	No
Primary	Change in condom use		baseline, 3 months	No
Primary	Change in substance use before or during sex		baseline, 3 months	No
Primary	Change in HIV knowledge		baseline, 3 months	No
Primary	Change in sex-related protective strategies		baseline, 3 months	No
Primary	Change in sexual intentions	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	baseline, 3 months	No
Primary	Change in HIV testing	Self-report of being tested in lifetime, past 3 months	baseline, 3 months	No