protocolSection identificationModule nctId: NCT06311838, orgStudyIdInfo id: 2023H0244, briefTitle: Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Opioid Use Disorder, conditions: Dual Diagnosis, conditions: Housing Problems, conditions: Mental Disorder in Adolescence, conditions: Risk Behavior, conditions: Homelessness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Using a dismantling, randomized controlled design, researchers will examine the singular and combined impact of Motivational Interviewing/Community Reinforcement Approach (MI/CRA) and Strengths-Based Outreach and Advocacy (SBOA) on substance use, mental health and other outcomes (e.g., housing stability, education, employment) with Youth Experiencing Homelessness (YEH) recruited from a local drop-in center., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Assessors will be blind to intervention condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Motivational Interviewing/Community Reinforcement Approach (MI/CRA), interventions name: Strengths-Based Outreach and Advocacy (SBOA ), interventions name: Services as Usual (SAU), outcomesModule primaryOutcomes measure: Form 90 Substance Use interview, primaryOutcomes measure: Shortened Inventory of Problems - Alcohol and Drugs (SIP-AD), primaryOutcomes measure: Presence of drugs of abuse, primaryOutcomes measure: Beck Depression Inventory II (BDI-II), primaryOutcomes measure: Beck Anxiety Inventory (BAI), primaryOutcomes measure: Short Form-12, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Star House, city: Columbus, state: Ohio, zip: 43201, country: United States, contacts name: Natasha Slesnick, PhD, role: CONTACT, phone: 614-247-8469, email: slesnick.5@osu.edu, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Ohio State University, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Jodi Ford, PhD, role: CONTACT, phone: 614-292-6862, email: ford.553@osu.edu, contacts name: Natasha Slesnick, PhD, role: CONTACT, phone: (614) 247-8469, email: slesnick.5@osu.edu, contacts name: Jodi Ford, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Natasha Slesnick, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False