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| ID | Type | Description | Link |
|---|---|---|---|
| UG3DA050189 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Washington State Department of Children, Youth and Families | UNKNOWN |
| Michigan State University | OTHER |
| RTI International |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced A-CRA (E-ACRA) | Experimental | Higher intensity |
|
| Assertive Community Support (ACS) | Experimental | Lower intensity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adolescent Community Reinforcement Approach | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant attendance | Number of sessions attended | 2 months post-release (Phase I) |
| Participant attendance | Number of sessions attended | 3 months post-release (Phase II) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Albertson | Contact | 206-568-5546 | katie.albertson@seattlechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Kym Ahrens, MD MPH | Seattle Children's Hospital | Principal Investigator |
| Kevin Haggerty, MSW PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington State Department of Children, Youth and Families | Recruiting | Olympia | Washington | 98504 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27614657 | Background | Martins SS, Segura LE, Santaella-Tenorio J, Perlmutter A, Fenton MC, Cerda M, Keyes KM, Ghandour LA, Storr CL, Hasin DS. Prescription opioid use disorder and heroin use among 12-34 year-olds in the United States from 2002 to 2014. Addict Behav. 2017 Feb;65:236-241. doi: 10.1016/j.addbeh.2016.08.033. Epub 2016 Aug 30. No abstract available. | |
| Background | Understanding the epidemic. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed 3-2-2019.2018. | ||
| Background | Forsyth CJ, Biggar RW, Chen J, Burstein K. Examining heroin use and prescription opioid misuse among adolescents. Criminal Justice Studies: A Critical Journal of Crime, Law & Society 2017;30:320-9. | ||
| 15963906 |
| Label | URL |
|---|---|
| Mortality and morbidity in the 21st century | View source |
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Individual participant data will be shared with other researchers in the HEAL Prevention Collaborative. Further specific detail will be reported as the plans are finalized.
Within four weeks of acceptance by a journal, we will deposit electronic copies of publications in PubMed Central.
Publications will be made publicly available immediately without any embargo period.
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000075665 | Recidivism |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000066479 | Criminal Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D013812 | Therapeutics |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D037001 | Directive Counseling |
| D003376 | Counseling |
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| OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
Sequential Multiple Assignment Randomized Trial
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The Outcomes Assessor (data collection team) will not be aware of the participant's study arm when they collect survey data.
|
|
| Assertive Continuing Care | Behavioral | 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 | Behavioral | 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 | Behavioral | Motivational interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change. |
|
|
| Opioid Education Workbook | Other | 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. |
|
|
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 |
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 |
| 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) |
| 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) |
| Background |
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| 39706330 | Derived | Brincks AM, Haggerty KP, Kolberg A, Albertson KM, McCarty CA, Kuklinski MR, Ryle T, Ahrens KR. Development of the Positive Outcomes through Supported Transition (POST) opioid preventive intervention for youth in the legal system: Study protocol for a sequential multiple assignment randomized trial. Contemp Clin Trials. 2025 Feb;149:107782. doi: 10.1016/j.cct.2024.107782. Epub 2024 Dec 18. |
| 39250243 | Derived | Ahrens KR, Brincks AM, Haggerty KP, McCarty CA, Dean S, Albertson KM, Cross SR, Ryle T, Wun A. Designing and piloting a sequential multiple assignment randomized trial for opioid prevention among youth in the legal system. Psychol Addict Behav. 2025 Feb;39(1):14-26. doi: 10.1037/adb0001025. Epub 2024 Sep 9. |
| 37393415 | Derived | Ahrens K, Blackburn N, Aalsma M, Haggerty K, Kelleher K, Knight DK, Joseph E, Mulford C, Ryle T, Tolou-Shams M. Prevention of Opioid Use and Disorder Among Youth Involved in the Legal System: Innovation and Implementation of Four Studies Funded by the NIDA HEAL Initiative. Prev Sci. 2023 Oct;24(Suppl 1):99-110. doi: 10.1007/s11121-023-01566-6. Epub 2023 Jul 1. |
| Benefit-Cost Analysis | View source |
| D000079524 |
| Narcotic-Related Disorders |
| D008605 |
| Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |