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NCT Number: NCT06311838

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

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.

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Key information

Conditions

Opioid Use Disorder Behavior Chemically-Induced Disorders Dual Diagnosis Homelessness Housing Problems Mental Disorder in Adolescence Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Risk Behavior Risk-Taking Substance-Related Disorders

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University, Columbus, Ohio, United States

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About this study

Specific Aim 1. Using a dismantling randomized design, compare intervention conditions to determine those components essential for optimizing substance use and mental health: a) Strengths-Based Outreach and Advocacy (SBOA), b) Motivational Interviewing (MI)/Community Reinforcement Approach (CRA), c) SBOA+MI/CRA, and d) Services As Usual (SAU). Hypothesis. Youth assigned to SBOA+MI/CRA will show better short and long-term outcomes on Opioid Use Disorder prevention and on other substance use and mental health outcomes than youth assigned to either intervention alone or Services As Usual.

Specific Aim 2. Test whether intended change processes (social stability, psychosocial resources, stress) produce the desired change on substance use and mental health. Hypothesis. Inasmuch as the interventions trigger successful increases in social stability and psychosocial resources and reductions in stress, targeted outcomes will improve.

Specific Aim 3. Explore how the moderators of age, sex, race/ethnicity, sexual/gender minority status, and experience of childhood abuse and neglect influence intervention response.

Specific Aim 4. Determine cost effectiveness of the intervention approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational Interviewing/Community Reinforcement Approach (MI/CRA)

Behavioral

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

Strengths-Based Outreach and Advocacy (SBOA )

Behavioral

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

Services as Usual (SAU)

Behavioral

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

Primary outcomes

  1. Form 90 Substance Use interview

    Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.

    Self-reported interviewer-administered Form 90 Substance Use interview developed for National Institute on Alcohol Abuse and Alcoholism (NIAAA) funded Project Match. The Form 90 differentiates illicit drug use from prescribed drug use including marijuana.

  2. 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.

    The SIP-AD measures consequences related to impulse control and social responsibility, as well as physical, interpersonal, and intrapersonal domains with good psychometric properties.

  3. Presence of drugs of abuse

    Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.

    One-step BMC ToxCup® Urine Test Kit Provides instant reading urine test for the presence or lack of detection of cannabinoids, amphetamines, methamphetamines, phencyclidine (PCP), cocaine/crack, and opiates. (Branan Medical Corp., Irvine, CA).

    Detection levels:

    Marijuana 50 ng/ml Cocaine 150 ng/ml Opiates 300 ng/ml Methamphetamine 500 ng/ml Ecstasy 500 ng/ml Phencyclidine 25 ng/ml Propoxyphene 300 ng/ml Benzodiazepines 300 ng/ml Barbiturates 300 ng/ml Methadone 300 ng/ml Buprenorphine 10 ng/ml Tricyclic Antidepressants 1000 ng/ml Oxycodone 100 ng/ml

  4. Beck Depression Inventory II (BDI-II)

    Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.

    The most frequently used self-report instrument to assess mood, cognitive and somatic aspects of depression. The BDI-II has good psychometric properties. Scores range from 0 - 63 with higher scores indicating more depressived symptoms and worse outcomes.

  5. Beck Anxiety Inventory (BAI)

    Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.

    Used to assess current anxiety symptoms via 21 items, rated in intensity with scores ranging from 0-63. It was developed to discriminate symptoms of anxiety from depressive symptoms, and has alpha coefficients ranging from 0.90-0.94. Higher scores indicate more anxiety symptoms and worse outcomes.

  6. Short Form-12

    Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.

    Standardized, internationally used instrument that provides a general measure of health status.The 12 items on the SF-12 are summarized in two weighted summary scales, and generate a mental health and physical health score. Scores range from 1 -100. Lower scores indicate poorer health. Construct validity has been evaluated with adult users of a homeless day shelter

Study contacts

Contact information is provided by the study sponsor or research team.

Jodi Ford, PhD

CONTACT

[email protected]

614-292-6862

Natasha Slesnick, PhD

CONTACT

[email protected]

(614) 247-8469

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Mar 15, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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