NCT02553616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
2.1 years until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

3.4 years

First QC Date

September 16, 2015

Last Update Submit

July 21, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • substance use

    Decreased use over time

    6 months

  • Condom use most recent sex

    Use of condom with most recent sexual experience

    6 months

Secondary Outcomes (1)

  • life satisfaction

    6 months

Other Outcomes (2)

  • condom use intention

    3 months

  • substance use refusal self-efficacy

    3 months

Study Arms (1)

Behavioral intervention

EXPERIMENTAL

Intervention to promote healthy behaviors.

Behavioral: Intervention to Promote Healthy Behaviors

Interventions

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

Behavioral intervention

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Currently enrolled in Alcoholics Anonymous or other substance treatment program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78701, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Donna L. Rew, EdD

    Professor, School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Data collectors were blinded to who received the pre-test and/or intervention.
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 17, 2015

Study Start

October 31, 2017

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations