An interventional study of Motivational Interviewing/Community Reinforcement Approach (MI/CRA) and Strengths-Based Outreach and Advocacy (SBOA ) in Opioid Use Disorder, Dual Diagnosis and Housing Problems, sponsored by Ohio State University. Recruiting at 2 sites in United States. Open to participants aged 14 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 300 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Motivational Interviewing/Community Reinforcement Approach (MI/CRA) · Behavioral: Services as Usual (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.
Behavioral: Strengths-Based Outreach and Advocacy (SBOA ) · Behavioral: Services as Usual (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.
Behavioral: Motivational Interviewing/Community Reinforcement Approach (MI/CRA) · Behavioral: Strengths-Based Outreach and Advocacy (SBOA ) · Behavioral: Services as Usual (SAU)
All youth will receive services as usual provided by the drop-in center.
Behavioral: Services as Usual (SAU)
MI/CRA includes two Motivational Interviewing sessions and twelve 1-hour Community Reinforcement Approach sessions.
The number of Strengths-Based Outreach and Advocacy sessions participants will receive are flexibly determined based upon youth needs.
Participants assigned to this group will receive the standard services provided to all youth involved with the drop-in center.
Form 90 Substance Use interview
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.
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)
The SIP-AD measures consequences related to impulse control and social responsibility, as well as physical, interpersonal, and intrapersonal domains with good psychometric properties.
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Presence of drugs of abuse
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
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Beck Depression Inventory II (BDI-II)
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.
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Beck Anxiety Inventory (BAI)
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.
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Short Form-12
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
Time frame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Plan to share: Yes — The proposed research for public-use data sharing will include three data types: survey data, stress biomarker data, and activity-space data. The final survey dataset will include self-reported demographic, behavioral, social (e.g. exposures to adversity, including homelessness, violence, incarceration, etc.) and health-related data (e.g. psychosocial measures, mental and physical health symptoms/disorders and diagnoses, health services). The data will be deposited with the Inter-University Consortium for Political and Social Research (ICPSR), an NIH funded data repository supported by National Institute on Drug Abuse as a data repository. The data from all 300 participants will be available for the six time-points of collection, made available in ICPSR preferred formats (e.g., CSV, SAS, SPSS) and securely transferred to ICPSR. Identifying (individual and location data) and personal health information will NOT be shared to protect participant confidentiality.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Started May 2024 (actual). Primary completion is estimated for Dec 2028, 54 months after the start.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 54 months is above that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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