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Recruiting Not applicable Interventional

Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness

ClinicalTrials.gov ID: NCT06311838

Public ClinicalTrials.gov record NCT06311838. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:44 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness: An RCT Examining Biopsychosocial Mechanisms

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Homelessness severely affects health and well-being and is particularly negative for youth. Between 70-95% of youth experiencing homelessness (YEH) report problem substance use and 66-89% have a mental health disorder. Youth appear to be at greater risk for living on the streets or being homeless than adults and are more vulnerable to long term consequences of homelessness. Multiple social determinants of health (SDOH) are uniquely associated with homelessness, driving substance use and adverse mental health consequences. However, limited research has identified pragmatic interventions that have a long-term ameliorating impact on the complex, multi-symptomatic issues among these youth. This study overcomes prior gaps in research through testing a multi-component comprehensive prevention intervention targeting SDOH that may affect biopsychosocial health indicators and longer-term health outcomes. In partnership with a drop-in center for YEH, youth between the ages of 14 to 24 years, will be engaged and randomly assigned to conditions using a dismantling design so that essential intervention components can be efficiently identified. In particular, youth (N = 300) will be randomly assigned to a) Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU, n = 80), b) Strengths-Based Outreach and Advocacy + Services As Usual (SBOA + SAU, n = 80), c) MI/CRA + SBOA + SAU (n = 80) or d) SAU (n=60) through the drop-in center. In order to assess the longer-term prevention effects on substance use, mental health and other outcomes, all youth will be assessed at baseline and at 3, 6, 12, 18 and 24-months post-baseline. The primary goal of this study is to establish the impact of a comprehensive intervention embedded within a system that serves YEH, a community drop-in center, on youth's opioid misuse and disorder, other substance misuse and disorders, mental health diagnoses, and other targeted outcomes. This study will offer unique information on the physiological and psychological stress pathways underlying change for specific subgroups of youth along with cost estimates to inform future implementation efforts in drop-in centers around the country.

Study identification

NCT ID
NCT06311838
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Ohio State University
Other
Enrollment
300 participants

Conditions and interventions

Eligibility (public fields only)

Age range
14 Years to 24 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 5, 2024
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029
Last update posted
Sep 21, 2025

2024 – 2029

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Star House Columbus Ohio 43201 Recruiting
Ohio State University Columbus Ohio 43210 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06311838, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 21, 2025 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06311838 live on ClinicalTrials.gov.

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