Clinical trial NCT06311838: Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness
Official title: Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness: An RCT Examining Biopsychosocial Mechanisms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Dual Diagnosis
Housing Problems
Mental Disorder in Adolescence
Risk Behavior
Homelessness
Keywords: youth experiencing homelessness
social determinants of health
opioid use disorder
substance use
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Form 90 Substance Use interview
timeFrame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
measure: Shortened Inventory of Problems - Alcohol and Drugs (SIP-AD)
timeFrame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
measure: Presence of drugs of abuse
timeFrame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
measure: Beck Anxiety Inventory (BAI)
timeFrame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
measure: Short Form-12
timeFrame: Administered at baseline, and 3-, 6-, and 12-, 18-, and 24-months post intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Star House
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References: