search
Back to results

An Intervention to Promote Healthy Behaviors in Homeless Youth

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention to Promote Healthy Behaviors
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use Disorders

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • does not have current secure place of residence,
  • receives services from a homeless street outreach center, and
  • is able to read and write English

Exclusion Criteria:

  • Currently enrolled in Alcoholics Anonymous or other substance treatment program

Sites / Locations

  • The University of Texas at Austin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral intervention

Arm Description

Intervention to promote healthy behaviors.

Outcomes

Primary Outcome Measures

substance use
Decreased use over time
Condom use most recent sex
Use of condom with most recent sexual experience

Secondary Outcome Measures

life satisfaction
Satisfaction with Life Scale Feels more satisfied with life

Full Information

First Posted
September 16, 2015
Last Updated
July 21, 2022
Sponsor
University of Texas at Austin
Collaborators
Ohio State University
search

1. Study Identification

Unique Protocol Identification Number
NCT02553616
Brief Title
An Intervention to Promote Healthy Behaviors in Homeless Youth
Official Title
An Intervention to Promote Healthy Behaviors in Homeless Youth
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigators will use a Solomon 4-group design to test the effectiveness of a brief intervention to promote health behaviors for homeless youth who are 18-23 years of age. We will recruit 300 youths from Austin, TX and 300 from Columbus, OH. We will gather quantitative data on health behaviors and life satisfaction 3 and 6 months following the intervention, which will be delivered on an individual basis. Data will be analyzed using structural equation modeling and ANCOVA statistics.
Detailed Description
The specific aims of this proposal are to: determine the effectiveness of a self-reflective preventive intervention to promote responsible substance use and safe sex behaviors (prevent HIV/AIDS) in homeless youths, ages18-23 years; determine whether psychological capital factors mediate the relationship between background risk factors (sexual orientation, duration of homelessness, sex abuse history, history of substance use, past sexual risk behaviors, and service utilization) and improved proximal outcomes (self-efficacy and intentions) and distal outcomes (responsible substance use, safer sex, life satisfaction); determine the effect of pre-testing on intervention proximal outcomes (immediately following intervention) and distal outcomes (at an interval of 3 and 6 months following intervention); and an exploratory aim to explore general and specific differences in proximal and distal outcomes of the intervention between participants in two geographically different sites (Austin, TX and Columbus, OH). We will recruit a total of 600 homeless youths from 2 drop-in centers in 2 geographic areas of the central US: Austin, TX and Columbus, OH. Using a Solomon four-group design with repeated measures, we will conduct a randomized controlled trial of a brief possible selves intervention (PSI) consisting of 6 brief individualized sessions that focus on generating images of one's possible self as feared or as best. Intervention participants will also receive weekly electronic messages to encourage them to move toward a goal of becoming their best possible self. Quantitative data will be collected before, immediately after the intervention, and at intervals of 3 and 6 months following intervention to test hypotheses about the effectiveness of the intervention on health behaviors and life satisfaction as well as the effects of pre-testing on these outcomes using structural equation modeling and ANCOVA statistics. The findings are expected to have a public health impact on further development of individualized services to promote healthy behaviors, healthy lifestyles and life satisfaction for vulnerable youths.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
This intervention has one (1) intervention arm. Participants were randomly assigned to the intervention with or without the pre-test or to receiving services as usual, with or without the pre-test.
Masking
None (Open Label)
Masking Description
Data collectors were blinded to who received the pre-test and/or intervention.
Allocation
Randomized
Enrollment
602 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral intervention
Arm Type
Experimental
Arm Description
Intervention to promote healthy behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Intervention to Promote Healthy Behaviors
Intervention Description
Six individualized sessions (30 minutes each) are delivered to each participant randomized to receive the intervention.
Primary Outcome Measure Information:
Title
substance use
Description
Decreased use over time
Time Frame
6 months
Title
Condom use most recent sex
Description
Use of condom with most recent sexual experience
Time Frame
6 months
Secondary Outcome Measure Information:
Title
life satisfaction
Description
Satisfaction with Life Scale Feels more satisfied with life
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
condom use intention
Description
plans to use condoms at next sexual intercourse
Time Frame
3 months
Title
substance use refusal self-efficacy
Description
confidence that one can refuse to use substances
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: does not have current secure place of residence, receives services from a homeless street outreach center, and is able to read and write English Exclusion Criteria: Currently enrolled in Alcoholics Anonymous or other substance treatment program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna L. Rew, EdD
Organizational Affiliation
Professor, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Intervention to Promote Healthy Behaviors in Homeless Youth

We'll reach out to this number within 24 hrs