An Intervention to Promote Healthy Behaviors in Homeless Youth

NCT ID: NCT02553616

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2021-03-31

Brief Summary

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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

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The specific aims of this proposal are to:

1. 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;
2. 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);
3. 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
4. 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.

Conditions

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Data collectors were blinded to who received the pre-test and/or intervention.

Study Groups

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Behavioral intervention

Intervention to promote healthy behaviors.

Group Type EXPERIMENTAL

Intervention to Promote Healthy Behaviors

Intervention Type BEHAVIORAL

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

Interventions

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Intervention to Promote Healthy Behaviors

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University

OTHER

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Donna L Rew

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donna L. Rew, EdD

Role: PRINCIPAL_INVESTIGATOR

Professor, School of Nursing

Locations

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The University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

References

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Rew L, Slesnick N, Kesler S, Rhee H. Mediation of Psychological Capital in Youth Experiencing Homelessness. Nurs Res. 2024 May-Jun 01;73(3):188-194. doi: 10.1097/NNR.0000000000000722. Epub 2024 Feb 8.

Reference Type DERIVED
PMID: 38652691 (View on PubMed)

Other Identifiers

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R01HD083576-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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