Preventing OUD in Justice-Involved Youth

Study Overview
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Brief Summary
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The United States is experiencing an opioid epidemic. Sadly, opioid-related fatalities are on the rise, causing profound emotional, financial, and cultural impacts. One way to reduce these negative impacts is to prevent people from developing opioid use problems in the first place. Research shows that youth and young adults in the juvenile justice system have higher rates of opioid use disorder than other young people in the general population. The POST Study seeks develop, implement and evaluate the effectiveness and cost of 2 opioid use prevention programs of varying intensities. The prevention programs are designed specifically for youth and young adults living in justice settings. It is implemented during the time they are transitioning out of incarceration and back into the community. The research team hopes their results will help justice settings implement their own effective opioid prevention programs in the future.

Detailed Description
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Non-prescription opioid use in adolescents and young adults is epidemic in our country and overdose-related fatalities are rising. Adolescents and young adults in justice settings have some of the highest rates of opioid use disorder (OUD), with national rates approaching 20%. The majority of these youth and young adults engage in problematic non-opioid substance use, which is a critical risk factor for OUD. Non-opioid substance use disorders (SUDs) and OUD, in turn, are two of the most important predictors of subsequent re-involvement in juvenile or criminal justice systems. In this study, researchers at Seattle Children's Research Institute, the University of Washington, Michigan State University, and Washington State Juvenile Rehabilitation/Department of Children Youth and Families will collaboratively develop and test an evaluation of OUD prevention interventions of varying intensities based on the Adolescent Community Reinforcement Approach with Assertive Continuing Care (ACRA+ACC). Multiple studies have established effectiveness of ACRA+ACC in reducing SUD; however, none has evaluated it as an OUD prevention strategy. SUD is incredibly common and costly among youth and young adults involved in juvenile justice systems. Thus, ACRA+ACC-based approaches are likely to be effective and cost-beneficial OUD prevention strategies for this group. Investigators seek to determine the optimal intensity of an ACRA+ACC-based OUD prevention intervention for AYAJS with and without non-opioid SUD, as these groups are likely to have differing prevention needs. To do so, they will use a Sequential Multiple Assignment Randomized Trial (SMART) study design to construct high-quality adaptive interventions with ACRA+ACC-based OUD prevention strategies of different intensity levels among youth with and without SUD. Based on self-reported substance use at 1 month post-release, participants may be re-randomized into another study arm. This will both address treatment need and provide data for subsequent effectiveness and cost analyses. In Phase I of this study, researchers collaboratively planned for a SMART experiment, i.e.: finalize infrastructure, recruitment, intervention, and data collection procedures; and create infrastructure for the possibility of future implementation of effective interventions. They conducted a pilot with 31 participants to assess feasibility of protocols and procedures, recruitment, engagement, and retention strategies in anticipation of a future larger trial. Phase I started in January 2021. In Phase II of this study, currently ongoing, researchers are conducting a SMART trial with 215 AYAJS aged 15-25, with or without SUD but without moderate or severe OUD, to evaluate ACRA/ACC-based interventions of various intensity levels for youth. They will also conduct cost, cost-effectiveness, and benefit-cost analyses to understand the relationships between intervention costs and outcomes. Phase II started in August 2021.

Official Title
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Identifying an Effective and Cost Beneficial Approach to Preventing OUD in Justice-Involved Youth

Conditions
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Substance Use Disorders, Recidivism

Intervention / Treatment
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* Behavioral: Adolescent Community Reinforcement Approach
* Behavioral: Assertive Continuing Care
* Behavioral: Trauma Affect Regulation Guide for Education and Therapy
* Behavioral: Motivational Interviewing
* Other: Opioid Education Workbook


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 15-25 Leaving a Washington State detention facility or group home in the next 5-7 months Able to speak/understand English sufficiently to participate meaningfully in the intervention and assessments Exclusion Criteria: Diagnosed with a moderate or severe Opioid Use Disorder Has a learning or mental health issue severe enough that they are unable to participate meaningfully in the intervention and assessments (e.g. schizophrenia or severe developmental disability)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential Multiple Assignment Randomized Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced A-CRA (E-ACRA)<br>Higher intensity | Behavioral: Adolescent Community Reinforcement Approach<br>* The Adolescent Community Reinforcement Approach (A-CRA) is a developmentally-appropriate behavioral treatment for youth and young adults ages 12 to 24 years old with substance use disorders. A-CRA seeks to increase the family, social, and educational/vocational reinforces to support recovery. This intervention has been implemented in outpatient, intensive outpatient, and residential treatment settings. A-CRA includes guidelines for three types of sessions: individuals alone, parents/caregivers alone, and individuals and parents/caregivers together. According to the individual's needs and self-assessment of happiness in multiple life areas, clinicians choose from a variety of A-CRA procedures that address, for example, problem-solving skills to cope with day-to-day stressors, communication skills, and active participation in positive social and recreational activities with the goal of improving life satisfaction and eliminating alcohol and substance use problems.<br>* Other names: ACRA;Behavioral: Assertive Continuing Care<br>* Assertive Continuing Care (ACC) uses Community Reinforcement Approach (CRA) procedures, home visits, and case management for individuals following an initial substance use treatment episode. It stresses rapid initiation of services after discharge from residential, intensive outpatient, or regular outpatient treatment in order to promote recovery and prevent relapse.<br>* Other names: ACC;Behavioral: Trauma Affect Regulation Guide for Education and Therapy<br>* Trauma Affect Regulation: Guide for Education and Therapy is a psychosocial intervention for traumatized adolescents, adults, and families, and for workforce and organizational responses to secondary/vicarious traumatization. T4, the 4-session version, provides education about the impact of complex traumatic stress on the brain's stress response system, and strengths-based practical skills for re-setting the trauma-related alarm/survival reactions that occur in complex PTSD.<br>* Other names: TARGET;Behavioral: Motivational Interviewing<br>* Motivational interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change.<br>* Other names: MI;Other: Opioid Education Workbook<br>* A digital workbook designed to be completed on a computer in about 2 hours. Topics include opioid use, opioid use disorder, and prevention and treatment of opioid overdose.<br>* Other names: Education;|
| Experimental: Assertive Community Support (ACS)<br>Lower intensity | Behavioral: Adolescent Community Reinforcement Approach<br>* The Adolescent Community Reinforcement Approach (A-CRA) is a developmentally-appropriate behavioral treatment for youth and young adults ages 12 to 24 years old with substance use disorders. A-CRA seeks to increase the family, social, and educational/vocational reinforces to support recovery. This intervention has been implemented in outpatient, intensive outpatient, and residential treatment settings. A-CRA includes guidelines for three types of sessions: individuals alone, parents/caregivers alone, and individuals and parents/caregivers together. According to the individual's needs and self-assessment of happiness in multiple life areas, clinicians choose from a variety of A-CRA procedures that address, for example, problem-solving skills to cope with day-to-day stressors, communication skills, and active participation in positive social and recreational activities with the goal of improving life satisfaction and eliminating alcohol and substance use problems.<br>* Other names: ACRA;Behavioral: Assertive Continuing Care<br>* Assertive Continuing Care (ACC) uses Community Reinforcement Approach (CRA) procedures, home visits, and case management for individuals following an initial substance use treatment episode. It stresses rapid initiation of services after discharge from residential, intensive outpatient, or regular outpatient treatment in order to promote recovery and prevent relapse.<br>* Other names: ACC;Behavioral: Motivational Interviewing<br>* Motivational interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change.<br>* Other names: MI;Other: Opioid Education Workbook<br>* A digital workbook designed to be completed on a computer in about 2 hours. Topics include opioid use, opioid use disorder, and prevention and treatment of opioid overdose.<br>* Other names: Education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of substance use episodes | Self-reported number of episodes of substance use on days any substance was used in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 2 months post-release (Phase I) | 
| Number of substance use episodes | Self-reported number of episodes of substance use on days any substance was used in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 3 months post-release (Phase II) | 
| Number of substance use episodes | Self-reported number of episodes of substance use on days any substance was used in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 6 months post-release (Phase II) | 
| Frequency of substance use episodes | Self-reported number of days of any substance use in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 2 months post-release (Phase I) | 
| Frequency of substance use episodes | Self-reported number of days of any substance use in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 3 months post-release (Phase II) | 
| Frequency of substance use episodes | Self-reported number of days of any substance use in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 6 months post-release (Phase II) | 
| Rate of Recidivism | Convictions in either the juvenile or adult justice system for offenses within an 18-month period | 12 months post-release | 
| Rate of Recidivism | Convictions in either the juvenile or adult justice system for offenses within an 18-month period | 18 months post-release | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new opioid users | Number of participants who ever used opioids among those who had never used at baseline based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | 6 months post-release (Phase II) | 
| Number of participants with escalated opioid use | Number of participants whose days of use increased compared to prior measure based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 2 months post-release vs. before incarceration (Phase I) | 
| Number of participants with escalated opioid use | Number of participants whose days of use increased compared to prior measure based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 3 months post-release vs. before incarceration (Phase II) | 
| Number of participants with escalated opioid use | Number of participants whose days of use increased compared to prior measure based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 6 months post-release vs. at 3 months post-release (Phase II) | 
| Number of use episodes of specific substances (e.g. opioids, marijuana, etc.) | Self-reported number of episodes of use of a specific substance on days that substance was used in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 2 months post-release (Phase I) | 
| Number of use episodes of specific substances (e.g. opioids, marijuana, etc.) | Self-reported number of episodes of use of a specific substance on days that substance was used in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 3 months post-release (Phase II) | 
| Number of use episodes of specific substances (e.g. opioids, marijuana, etc.) | Self-reported number of episodes of use of a specific substance on days that substance was used in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 6 months post-release (Phase II) | 
| Frequency of use of specific substances (e.g. opioids, marijuana, etc.) | Self-reported number of days a specific substance was used in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 2 months post-release (Phase I) | 
| Frequency of use of specific substances (e.g. opioids, marijuana, etc.) | Self-reported number of days a specific substance was used in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 3 months post-release (Phase II) | 
| Frequency of use of specific substances (e.g. opioids, marijuana, etc.) | Self-reported number of days a specific substance was used in the past 30 days based on questions developed in collaboration with coordinating center Research Triangle Institute and other grantees. | Last 30 days at 6 months post-release (Phase II) | 
| Number of instances of overdose among non-opioid users | Self-reported number of instances of overdose | Last 30 days at 3 months post-release (Phase II) | 
| Number of instances of overdose among non-opioid users | Self-reported number of instances of overdose | Last 30 days at 6 months post-release (Phase II) | 
| Problematic substance use | Self-reported substance use beyond a developmentally appropriate threshhold. For those under age 21, problematic use is defined as any of the following: 1) use of alcohol or marijuana several times a week or more; 2) use of any other drugs, or dabbing marijuana 1-2 times per month or more; 3) score on CRAFFT of 2 or more (https://crafft.org). For those age 21 and older, problematic use is defined as any of the following: 1) use of alcohol or marijuana every day or most days each week; 2) use of any other drugs, or dabbing marijuana 1-2 times per month or more; 3) score on CRAFFT of 2 or more (https://crafft.org) | Last 30 days at 6 months post-release (Phase II) | 
| Problematic substance use | Self-reported substance use beyond a developmentally appropriate threshhold. For those under age 21, problematic use is defined as any of the following: 1) use of alcohol or marijuana several times a week or more; 2) use of any other drugs, or dabbing marijuana 1-2 times per month or more; 3) score on CRAFFT of 2 or more (https://crafft.org). For those age 21 and older, problematic use is defined as any of the following: 1) Use of alcohol or marijuana every day or most days each week; 2) Use of any other drugs, or dabbing marijuana 1-2 times per month or more; 3) Score on CRAFFT of 2 or more (https://crafft.org) | Last 30 days at 3 months post-release (Phase II) | 
| Cost of ACRA Lite (medium intensity arm) per participant | Cost in US Dollars of ACRA Lite intervention from study's Cost Analysis program | 3 months post-release | 
| Cost of Enhanced ACRA (high intensity arm) per participant | Cost in US Dollars of Enhanced ACRA intervention from study's Cost Analysis program | 3 months post-release | 
| Cost of Education Workbook (low intensity arm) per participant | Cost in US Dollars of Education Workbook intervention from study's Cost Analysis program | at release | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juvenile Rehabilitation, Adolescent, Young Adult, Juvenile Justice, Opioids, Opioid Use Disorder, Substance Use, Prevention, Recidivism, Substance Use Disorder, Cost Effectiveness, Benefit Cost Analysis