Preventing OUD in Justice-Involved Youth
- Conditions
- RecidivismSubstance Use Disorders
- Interventions
- Behavioral: Adolescent Community Reinforcement ApproachBehavioral: Assertive Continuing CareBehavioral: Motivational InterviewingBehavioral: Trauma Affect Regulation Guide for Education and TherapyOther: Opioid Education Workbook
- Registration Number
- NCT04901312
- Lead Sponsor
- Seattle Children's Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 215
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Enhanced A-CRA (E-ACRA) Assertive Continuing Care Higher intensity Assertive Community Support (ACS) Motivational Interviewing Lower intensity Enhanced A-CRA (E-ACRA) Trauma Affect Regulation Guide for Education and Therapy Higher intensity Enhanced A-CRA (E-ACRA) Opioid Education Workbook Higher intensity Enhanced A-CRA (E-ACRA) Adolescent Community Reinforcement Approach Higher intensity Enhanced A-CRA (E-ACRA) Motivational Interviewing Higher intensity Assertive Community Support (ACS) Assertive Continuing Care Lower intensity Assertive Community Support (ACS) Opioid Education Workbook Lower intensity Assertive Community Support (ACS) Adolescent Community Reinforcement Approach Lower intensity
- Primary Outcome Measures
Name Time Method Rate of Recidivism 18 months post-release Convictions in either the juvenile or adult justice system for offenses within an 18-month period
Frequency of substance use episodes Last 30 days at 6 months post-release (Phase II) 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.
Number of substance use episodes Last 30 days at 6 months post-release (Phase II) 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.
- Secondary Outcome Measures
Name Time Method Cost of Enhanced ACRA (high intensity arm) per participant 3 months post-release Cost in US Dollars of Enhanced ACRA intervention from study's Cost Analysis program
Number of use episodes of specific substances (e.g. opioids, marijuana, etc.) Last 30 days at 6 months post-release (Phase II) 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.
Number of new opioid users 6 months post-release (Phase II) 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.
Number of participants with escalated opioid use Last 30 days at 6 months post-release vs. at 3 months post-release (Phase II) 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.
Frequency of use of specific substances (e.g. opioids, marijuana, etc.) Last 30 days at 6 months post-release (Phase II) 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.
Number of instances of overdose among non-opioid users Last 30 days at 6 months post-release (Phase II) Self-reported number of instances of overdose
Cost of ACRA Lite (medium intensity arm) per participant 3 months post-release Cost in US Dollars of ACRA Lite intervention from study's Cost Analysis program
Problematic substance use Last 30 days at 3 months post-release (Phase II) 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)Cost of Education Workbook (low intensity arm) per participant at release Cost in US Dollars of Education Workbook intervention from study's Cost Analysis program
Trial Locations
- Locations (1)
Washington State Department of Children, Youth and Families
🇺🇸Olympia, Washington, United States