Preventing OUD in Justice-Involved Youth

Substance Use Disorders Clinical Trial

— POST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04901312
• Other study ID #: 2019-131-DCYF
• Secondary ID: UG3DA050189
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2022
• Source: Seattle Children's Hospital
• Contact: Katie Albertson
• Phone: 206-568-5546
• Email: katie.albertson[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Recidivism
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Adolescent Community Reinforcement Approach
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.
• Assertive Continuing Care
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.
• Trauma Affect Regulation Guide for Education and Therapy
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.
• Motivational Interviewing
Motivational interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change.

Other:
• Opioid Education Workbook
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.

Locations

Country	Name	City	State
United States	Washington State Department of Children, Youth and Families	Olympia	Washington

Sponsors (6)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Michigan State University, National Institute on Drug Abuse (NIDA), RTI International, University of Washington, Washington State Department of Children, Youth and Families

Country where clinical trial is conducted

United States, 

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant attendance	Number of sessions attended	2 months post-release (Phase I)
Other	Participant attendance	Number of sessions attended	3 months post-release (Phase II)
Other	Participant satisfaction	Self-reported satisfaction with coach on a scale of very satisfied, somewhat satisfied, not very satisfied, not at all satisfied	2 months post-release (Phase I)
Other	Participant satisfaction	Self-reported satisfaction with coach on a scale of very satisfied, somewhat satisfied, not very satisfied, not at all satisfied	3 months post-release (Phase II)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Rate of Recidivism	Convictions in either the juvenile or adult justice system for offenses within an 18-month period	12 months post-release
Primary	Rate of Recidivism	Convictions in either the juvenile or adult justice system for offenses within an 18-month period	18 months post-release
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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

External Links

•   Benefit-Cost Analysis
•   Information about opioids
•   Mortality and morbidity in the 21st century
•   The opioid epidemic
•   Understanding the opioid epidemic