Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT06311838

Conditions

Opioid Use Disorder

Dual Diagnosis

Housing Problems

Mental Disorder in Adolescence

Risk Behavior

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Not accepted

Interventions

Motivational Interviewing/Community Reinforcement Approach (MI/CRA)

Strengths-Based Outreach and Advocacy (SBOA )

Services as Usual (SAU)

Study Details

Brief summary:

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.

Conditions

Opioid Use Disorder

Dual Diagnosis

Housing Problems

Mental Disorder in Adolescence

Risk Behavior

Study ID

NCT06311838

Start date

May 6, 2024

Status verified date

Sep, 2025

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Youth must meet the criteria for homelessness as defined by the McKinney-Vento Act: children and youth who lack a fixed, regular, and adequate nighttime residence; or live in a welfare hotel, or place without regular sleeping accommodations, or live in a shared residence with other persons due to the loss of one's housing or economic hardship
  • Must speak english adequately to complete measures

Exclusion Criteria:

  • Youth who have a stable housing situation.
  • Non-English speaker

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Motivational Interviewing/Community Reinforcement Approach + Services as Usual (MI/CRA + SAU)

The current evidence base recommends integrating treatments targeting both Substance Use Disorder and psychiatric disorders, especially combining Motivational Interviewing with behavioral interventions such as CRA or Cognitive Behaviorial Therapy.

Enhancing intrinsic motivation for behavioral change is the central purpose of motivational interviewing (MI), a clinical method built on the insights and strategies described by Carl Rogers as client-centered therapy. MI is also directive, however, in selectively eliciting and reinforcing client "change talk". Typically offered as a brief intervention of 1-2 sessions, MI has a strong record of efficacy in the treatment of alcohol and other drug use disorders, mental health and other problematic behaviors.

The Community Reinforcement Approach (CRA) offers an empirically-based multifaceted approach to substance abuse/mental health treatment that also addresses many of the clinical needs of multi-problem homeless individuals.

experimental: Strengths-Based Outreach and Advocacy + Services As Usual (SBOA +SAU)

Some research suggests that engagement with an advocate is key to success when linking those experiencing homelessness to available services and supports in the community. The strengths model is based on the premise that the purpose of advocacy "is to assist consumers in identifying, securing, and preserving the range of resources, both external and internal, needed to live in a normal, independent way in the community". Strengths-based interventions focus on enhancing well-being and happiness rather than attempting to correct deficits or pathology. The advocate takes responsibility for securing needed services for the youth and remains a support as they traverse the system of care. The focus of the first several weeks of advocacy is on obtaining identification and ensuring basic needs are met (food, safety, medical care, housing, etc.). As basic needs are addressed, youth and advocates focus on other high need areas including education, employment, mental health and substance use.

experimental: Motivational Interviewing/Community Reinforcement Approach (MI/CRA) + SBOA + SAU

This intervention combines all three interventional models: Motivational Interviewing/Community Reinforcement Approach along with Strengths-Based Outreach and Advocacy and the Services as Usual.

active comparator: Services as Usual (SAU)

All youth will receive services as usual provided by the drop-in center.

Interventions

Motivational Interviewing/Community Reinforcement Approach (MI/CRA)

MI/CRA includes two Motivational Interviewing sessions and twelve 1-hour Community Reinforcement Approach sessions.

Strengths-Based Outreach and Advocacy (SBOA )

The number of Strengths-Based Outreach and Advocacy sessions participants will receive are flexibly determined based upon youth needs.

Services as Usual (SAU)

Participants assigned to this group will receive the standard services provided to all youth involved with the drop-in center.

Primary outcome measure

  • Form 90 Substance Use interview [ Time Frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention. ]
  • Shortened Inventory of Problems - Alcohol and Drugs (SIP-AD) [ Time Frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention. ]
  • Presence of drugs of abuse [ Time Frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention. ]
  • Beck Depression Inventory II (BDI-II) [ Time Frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention. ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention. ]
  • Short Form-12 [ Time Frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention. ]

Central Contacts and Locations

Central contacts

Jodi Ford, PhD

614-292-6862ford.553@osu.edu

Natasha Slesnick, PhD

(614) 247-8469slesnick.5@osu.edu

Locations

Star House

Recruiting

Columbus, Ohio, United States, 43201

Contacts

Natasha Slesnick, PhD

614-247-8469slesnick.5@osu.edu

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Jodi Ford, PhD

614-292-6862ford.553@osu.edu

Natasha Slesnick, PhD

(614) 247-8469slesnick.5@osu.edu

Principal Investigator:

Jodi Ford, PhD

More Information

Sponsor

Ohio State University

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • youth experiencing homelessness
  • social determinants of health
  • opioid use disorder
  • substance use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-09-22.