Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311838
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-02-26
Brief Title:
Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Building Social and Structural Connections for the Prevention of Opioid Use Disorder Among Youth Experiencing Homelessness An RCT Examining Biopsychosocial Mechanisms
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 InterviewingCommunity Reinforcement Approach Services as Usual MICRA SAU n 80 b Strengths-Based Outreach and Advocacy Services As Usual SBOA SAU n 80 c MICRA SBOA SAU n 80 or d SAU n60 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 youths 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 MICommunity Reinforcement Approach CRA c SBOAMICRA and d Services As Usual SAU Hypothesis Youth assigned to SBOAMICRA 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 raceethnicity sexualgender minority status and experience of childhood abuse and neglect influence intervention response
Specific Aim 4 Determine cost effectiveness of the intervention approaches
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 raceethnicity sexualgender minority status and experience of childhood abuse and neglect influence intervention response
Specific Aim 4 Determine cost effectiveness of the intervention approaches
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None