Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth

June 17, 2021 updated by: Joan Tucker, RAND

Brief Group MI Intervention for AOD Use and Sexual Risk Behavior in Homeless Youth

This study will evaluate a program called AWARE, which is a voluntary four session group-based motivational interviewing (MI) intervention to reduce substance use and sexual risk behavior among 18-25 year olds who are experiencing homelessness. The hypothesis is that participants who receive AWARE will show greater reductions in substance use and sexual risk behavior over a 12 month period compared to participants who do not receive the program.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Hollywood, California, United States, 90028
        • My Friend's Place
      • Los Angeles, California, United States, 90038
        • Youth Center on Highland
      • Venice Beach, California, United States, 90291
        • Safe Place for Youth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 to 25; seeking services at one of the participating drop-in centers; no cognitive impairment observed during the screening process; planning to be in the study area for the next month; has either an email account or cell phone where they can be reached; and English speaking.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AWARE condition
AWARE is a four-session Motivational Interviewing (MI)-informed group risk reduction intervention that incorporates education, skills building and personalized feedback.
AWARE consists of four group sessions. The AWARE curriculum involves sharing basic information on sexually transmitted diseases; providing condom use skills training; providing normative feedback on substance use and sexual risk behavior among young adults; discussing unrealistic beliefs about substance use and sexual risk; discussing potential benefits of both cutting down and stopping risky behaviors; and discussing risky situations and coping strategies.
No Intervention: Standard Care condition
Participants in the Standard Care condition have access to "usual care" at the drop-in center where the study is being conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substance use
Time Frame: 12 months
frequency and quantity of alcohol and drug use
12 months
Unprotected sex
Time Frame: 12 months
proportion of condom-unprotected sexual events
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2018

Primary Completion (Actual)

March 23, 2021

Study Completion (Actual)

March 23, 2021

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • R01AA025641 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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