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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311838
• Other study ID #: 2023H0244
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: December 1, 2029

Study information

• Verified date: June 2024
• Source: Ohio State University
• Contact: Jodi Ford, PhD
• Phone: 614-292-6862
• Email: ford.553[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2029
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Dual Diagnosis
• Homelessness
• Housing Problems
• Mental Disorder in Adolescence
• Mental Disorders
• Opioid Use Disorder
• Opioid-Related Disorders
• Risk Behavior
• Substance-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio
United States	Star House	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Primary	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.	Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Primary	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	Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Primary	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.	Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Primary	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.	Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Primary	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	Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.