Substance Use DisordersPOSTNCT04901312
Preventing OUD in Justice-Involved Youth
A study testing Adolescent Community Reinforcement Approach, Assertive Continuing Care and Trauma Affect Regulation Guide for Education and Therapy in people with Substance Use Disorders and Recidivism, run by Seattle Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Substance Use Disorders, Recidivism
- What is being tested?
- Adolescent Community Reinforcement Approach, Assertive Continuing Care and Trauma Affect Regulation Guide for Education and Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington State Department of Children, Youth and Families
Olympia, Washington, 98504
Robert Hopkins, 360-701-4615, robert.hopkins@dcyf.wa.gov
Ted Ryle, MSW MA
About this study
Official title: Identifying an Effective and Cost Beneficial Approach to Preventing OUD in Justice-Involved Youth
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.
Read the 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.
- Conditions
- Substance Use Disorders, Recidivism
- Being tested
- Adolescent Community Reinforcement Approach, Assertive Continuing Care, Trauma Affect Regulation Guide for Education and Therapy, Motivational Interviewing, Opioid Education Workbook
- Keywords
- Juvenile Rehabilitation, Adolescent, Young Adult, Juvenile Justice, Opioids, Opioid Use Disorder, Substance Use, Prevention, Recidivism, Substance Use Disorder, Cost Effectiveness, Benefit Cost Analysis
- Medical subject headings
- Substance-Related Disorders, Recidivism, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Community Reinforcement ApproachBehavioural
Also called A-CRA, ACRA
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 CareBehavioural
Also called ACC
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 TherapyBehavioural
Also called T4, TARGET
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 InterviewingBehavioural
Also called MI
Motivational interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change.
Opioid Education WorkbookOther
Also called Education
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced A-CRA (E-ACRA) | Experimental | Higher intensity Receives: 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 |
| Assertive Community Support (ACS) | Experimental | Lower intensity Receives: Behavioral: Adolescent Community Reinforcement Approach; Behavioral: Assertive Continuing Care; Behavioral: Motivational Interviewing; Other: Opioid Education Workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months post-release
Rate of Recidivism
Convictions in either the juvenile or adult justice system for offenses within an 18-month period
Measured: 18 months post-release
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: at release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start20 Jan 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Multiple Assignment Randomized Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Washington State Department of Children, Youth and Families, Michigan State University, RTI International, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kym Ahrens, Seattle Children's Hospital
- Investigators
- Kym Ahrens, MD MPH, Principal investigator, Seattle Children's HospitalKevin Haggerty, MSW PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901312
- Sponsor's protocol ID
- 2019-131-DCYF
- Other IDs
- UG3DA050189
- Acronym
- POST
- Status last verified
- Oct 2022
- First submitted
- 11 Feb 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27614657Understanding the epidemic. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed 3-2-2019.2018.
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.
Sung HE, Richter L, Vaughan R, Johnson PB, Thom B. Nonmedical use of prescription opioids among teenagers in the United States: trends and correlates. J Adolesc Health. 2005 Jul;37(1):44-51. doi: 10.1016/j.jadohealth.2005.02.013.
PubMed 15963906Vaughn MG, Fu Q, Perron BE, Wu LT. Risk profiles among adolescent nonmedical opioid users in the United States. Addict Behav. 2012 Aug;37(8):974-7. doi: 10.1016/j.addbeh.2012.03.015. Epub 2012 Mar 27.
PubMed 22525786Wojciechowski TW. Developmental Trajectories of Opioid Use Among Juvenile Offenders: An Epidemiological Examination of Group Characteristics and Criminological Risk Factors. Subst Use Misuse. 2019;54(7):1203-1213. doi: 10.1080/10826084.2019.1573837. Epub 2019 Feb 15.
PubMed 30767596Mulvey EP, Schubert CA, Chassin L. Substance Use and Offending in Serious Adolescent Offenders. In: Department of Justice OoJP, Office of Juvenile Justice and Delinquency Prevention., ed. Washington, DC: U.S. 2010.
Grisso T. Double jeopardy: adolescent offenders with mental disorders. Chicago: University of Chicago Press; 2004.
Ghandour LA, El Sayed DS, Martins SS. Alcohol and illegal drug use behaviors and prescription opioids use: how do nonmedical and medical users compare, and does motive to use really matter? Eur Addict Res. 2013;19(4):202-10. doi: 10.1159/000345445. Epub 2013 Feb 7.
PubMed 23391856Cheng T, Small W, Nosova E, Hogg B, Hayashi K, Kerr T, DeBeck K. Nonmedical prescription opioid use and illegal drug use: initiation trajectory and related risks among people who use illegal drugs in Vancouver, Canada. BMC Res Notes. 2018 Jan 16;11(1):35. doi: 10.1186/s13104-018-3152-9.
PubMed 29338770Jones CM, McCance-Katz EF. Co-occurring substance use and mental disorders among adults with opioid use disorder. Drug Alcohol Depend. 2019 Apr 1;197:78-82. doi: 10.1016/j.drugalcdep.2018.12.030. Epub 2019 Feb 14.
PubMed 30784952Scott T, Brown SL. Risks, strengths, gender, and recidivism among justice-involved youth: A meta-analysis. J Consult Clin Psychol. 2018 Nov;86(11):931-945. doi: 10.1037/ccp0000343.
PubMed 30335425The National Center for Addiction and Substance Abuse Research, Columbia University. Criminal Neglect: Substance Abuse, Juvenile Justice and The Children Left Behind. 2004.
Mulvey EP. Highlights From Pathways to Desistance: A Longitudinal Study of Serious Adolescent Offenders. 2011.
Godley SH, Smith JE, Meyers RJ, Godley MD. The Adolescent Community Reinforcement Approach: A Clinical Guide for Treating Substance Use Disorders. Normal, IL: Chestnut Health Systems; 2016.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying an Effective and Cost Beneficial Approach to Preventing OUD in Justice-Involved Youth
- ClinicalTrials.gov ID
- NCT04901312
- Acronym / sponsor ID
- POST / 2019-131-DCYF
- Conditions
- Substance Use Disorders, Recidivism
- Keywords
- Juvenile Rehabilitation, Adolescent, Young Adult, Juvenile Justice, Opioids, Opioid Use Disorder, Substance Use, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington, Washington State Department of Children, Youth and Families, Michigan State University, RTI International, National Institute on Drug Abuse (NIDA)
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential Multiple Assignment Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| Enhanced A-CRA (E-ACRA) | Experimental | Behavioral: Adolescent Community Reinforcement Approach, Behavioral: Assertive Continuing Care, Behavioral: Trauma Affect Regulation Guide for Education and Therapy, Behavioral: Motivational Interviewing, Other: Opioid Education WorkbookHigher intensity |
| Assertive Community Support (ACS) | Experimental | Behavioral: Adolescent Community Reinforcement Approach, Behavioral: Assertive Continuing Care, Behavioral: Motivational Interviewing, Other: Opioid Education WorkbookLower intensity |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adolescent Community Reinforcement ApproachAlso: A-CRA, ACRAThe 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. | Behavioural | Assertive Community Support (ACS), Enhanced A-CRA (E-ACRA) |
| Assertive Continuing CareAlso: ACCAssertive 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. | Behavioural | Assertive Community Support (ACS), Enhanced A-CRA (E-ACRA) |
| Trauma Affect Regulation Guide for Education and TherapyAlso: T4, TARGETTrauma 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. | Behavioural | Enhanced A-CRA (E-ACRA) |
| Motivational InterviewingAlso: MIMotivational interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change. | Behavioural | Assertive Community Support (ACS), Enhanced A-CRA (E-ACRA) |
| Opioid Education WorkbookAlso: EducationA 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. | Other | Assertive Community Support (ACS), Enhanced A-CRA (E-ACRA) |
Primary outcome
Number of substance use episodes
Time frame: Last 30 days at 2 months post-release (Phase I)
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.
Number of substance use episodes
Time frame: Last 30 days at 3 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.
Number of substance use episodes
Time frame: 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.
Frequency of substance use episodes
Time frame: Last 30 days at 2 months post-release (Phase I)
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.
Frequency of substance use episodes
Time frame: Last 30 days at 3 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.
Frequency of substance use episodes
Time frame: 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.
Rate of Recidivism
Time frame: 12 months post-release
Convictions in either the juvenile or adult justice system for offenses within an 18-month period
Rate of Recidivism
Time frame: 18 months post-release
Convictions in either the juvenile or adult justice system for offenses within an 18-month period
17 secondary outcomes
Number of new opioid users
Time frame: 6 months post-release (Phase II)
Number of participants with escalated opioid use
Time frame: Last 30 days at 2 months post-release vs. before incarceration (Phase I)
Number of participants with escalated opioid use
Time frame: Last 30 days at 3 months post-release vs. before incarceration (Phase II)
Number of participants with escalated opioid use
Time frame: 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.)
Time frame: Last 30 days at 2 months post-release (Phase I)
Number of use episodes of specific substances (e.g. opioids, marijuana, etc.)
Time frame: Last 30 days at 3 months post-release (Phase II)
Number of use episodes of specific substances (e.g. opioids, marijuana, etc.)
Time frame: Last 30 days at 6 months post-release (Phase II)
Frequency of use of specific substances (e.g. opioids, marijuana, etc.)
Time frame: Last 30 days at 2 months post-release (Phase I)
Frequency of use of specific substances (e.g. opioids, marijuana, etc.)
Time frame: Last 30 days at 3 months post-release (Phase II)
Frequency of use of specific substances (e.g. opioids, marijuana, etc.)
Time frame: Last 30 days at 6 months post-release (Phase II)
Number of instances of overdose among non-opioid users
Time frame: Last 30 days at 3 months post-release (Phase II)
Number of instances of overdose among non-opioid users
Time frame: Last 30 days at 6 months post-release (Phase II)
Problematic substance use
Time frame: Last 30 days at 6 months post-release (Phase II)
Problematic substance use
Time frame: Last 30 days at 3 months post-release (Phase II)
Cost of ACRA Lite (medium intensity arm) per participant
Time frame: 3 months post-release
Cost of Enhanced ACRA (high intensity arm) per participant
Time frame: 3 months post-release
Cost of Education Workbook (low intensity arm) per participant
Time frame: at release
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 27614657Martins 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.
- BackgroundUnderstanding the epidemic. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed 3-2-2019.2018.
- BackgroundForsyth 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.
- Background: PubMed 15963906Sung HE, Richter L, Vaughan R, Johnson PB, Thom B. Nonmedical use of prescription opioids among teenagers in the United States: trends and correlates. J Adolesc Health. 2005 Jul;37(1):44-51. doi: 10.1016/j.jadohealth.2005.02.013.
- Background: PubMed 22525786Vaughn MG, Fu Q, Perron BE, Wu LT. Risk profiles among adolescent nonmedical opioid users in the United States. Addict Behav. 2012 Aug;37(8):974-7. doi: 10.1016/j.addbeh.2012.03.015. Epub 2012 Mar 27.
- Background: PubMed 30767596Wojciechowski TW. Developmental Trajectories of Opioid Use Among Juvenile Offenders: An Epidemiological Examination of Group Characteristics and Criminological Risk Factors. Subst Use Misuse. 2019;54(7):1203-1213. doi: 10.1080/10826084.2019.1573837. Epub 2019 Feb 15.
- BackgroundMulvey EP, Schubert CA, Chassin L. Substance Use and Offending in Serious Adolescent Offenders. In: Department of Justice OoJP, Office of Juvenile Justice and Delinquency Prevention., ed. Washington, DC: U.S. 2010.
- BackgroundGrisso T. Double jeopardy: adolescent offenders with mental disorders. Chicago: University of Chicago Press; 2004.
- Background: PubMed 23391856Ghandour LA, El Sayed DS, Martins SS. Alcohol and illegal drug use behaviors and prescription opioids use: how do nonmedical and medical users compare, and does motive to use really matter? Eur Addict Res. 2013;19(4):202-10. doi: 10.1159/000345445. Epub 2013 Feb 7.
- Background: PubMed 29338770Cheng T, Small W, Nosova E, Hogg B, Hayashi K, Kerr T, DeBeck K. Nonmedical prescription opioid use and illegal drug use: initiation trajectory and related risks among people who use illegal drugs in Vancouver, Canada. BMC Res Notes. 2018 Jan 16;11(1):35. doi: 10.1186/s13104-018-3152-9.
- Background: PubMed 30784952Jones CM, McCance-Katz EF. Co-occurring substance use and mental disorders among adults with opioid use disorder. Drug Alcohol Depend. 2019 Apr 1;197:78-82. doi: 10.1016/j.drugalcdep.2018.12.030. Epub 2019 Feb 14.
- Background: PubMed 30335425Scott T, Brown SL. Risks, strengths, gender, and recidivism among justice-involved youth: A meta-analysis. J Consult Clin Psychol. 2018 Nov;86(11):931-945. doi: 10.1037/ccp0000343.
- Mortality and morbidity in the 21st centuryLink provided by the sponsor.
- Benefit-Cost AnalysisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kym Ahrens, MD MPH principal investigator
Seattle Children's Hospital
Kevin Haggerty, MSW PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent Community Reinforcement Approach, Assertive Continuing Care and Trauma Affect Regulation Guide for Education and Therapy in people with Substance Use Disorders and Recidivism, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katie Albertson (206-568-5546, katie.albertson@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of substance use episodes (time frame: Last 30 days at 2 months post-release (Phase I)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901312, which also lists 57 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.