An Intervention to Promote Healthy Behaviors in Homeless Youth

Sponsor

University of Texas at Austin (Other)

Overall Status

Completed

CT.gov ID

NCT02553616

Collaborator

Ohio State University (Other)

602

Enrollment

Location

Arm

Actual Duration (Months)

14.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders	Behavioral: Intervention to Promote Healthy Behaviors	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

602 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention 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.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.

Primary Purpose:

Prevention

Official Title:

An Intervention to Promote Healthy Behaviors in Homeless Youth

Actual Study Start Date :

Oct 31, 2017

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral intervention Intervention to promote healthy behaviors.	Behavioral: Intervention to Promote Healthy Behaviors Six individualized sessions (30 minutes each) are delivered to each participant randomized to receive the intervention.

Arm

Intervention/Treatment

Experimental: Behavioral intervention

Intervention to promote healthy behaviors.

Behavioral: Intervention to Promote Healthy Behaviors

Six individualized sessions (30 minutes each) are delivered to each participant randomized to receive the intervention.

Outcome Measures

Primary Outcome Measures

substance use [6 months]
Decreased use over time
Condom use most recent sex [6 months]
Use of condom with most recent sexual experience

Secondary Outcome Measures

life satisfaction [6 months]
Satisfaction with Life Scale Feels more satisfied with life

Other Outcome Measures

condom use intention [3 months]
plans to use condoms at next sexual intercourse
substance use refusal self-efficacy [3 months]
confidence that one can refuse to use substances

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas at Austin	Austin	Texas	United States	78701

Sponsors and Collaborators

University of Texas at Austin
Ohio State University

Investigators

Principal Investigator: Donna L. Rew, EdD, Professor, School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Donna L Rew, Professor, University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT02553616

Other Study ID Numbers:

R01HD083576-01A1

First Posted:

Sep 17, 2015

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Jul 26, 2022