Clinical trial NCT04901312: Preventing OUD in Justice-Involved Youth
Official title: Identifying an Effective and Cost Beneficial Approach to Preventing OUD in Justice-Involved Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use Disorders
Recidivism
Keywords: Juvenile Rehabilitation
Adolescent
Young Adult
Juvenile Justice
Opioids
Opioid Use Disorder
Substance Use
Prevention
Recidivism
Substance Use Disorder
Cost Effectiveness
Benefit Cost Analysis
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Washington State Department of Children, Youth and Families
name: Michigan State University
name: RTI International
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-05-25
Enrollment: 215
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Multiple Assignment Randomized Trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of substance use episodes
timeFrame: Last 30 days at 2 months post-release (Phase I)
measure: Number of substance use episodes
timeFrame: Last 30 days at 3 months post-release (Phase II)
measure: Number of substance use episodes
timeFrame: Last 30 days at 6 months post-release (Phase II)
measure: Frequency of substance use episodes
timeFrame: Last 30 days at 2 months post-release (Phase I)
measure: Frequency of substance use episodes
timeFrame: Last 30 days at 3 months post-release (Phase II)
measure: Frequency of substance use episodes
timeFrame: Last 30 days at 6 months post-release (Phase II)
measure: Rate of Recidivism
timeFrame: 12 months post-release
measure: Rate of Recidivism
timeFrame: 18 months post-release
Secondary outcomes:
measure: Number of new opioid users
timeFrame: 6 months post-release (Phase II)
measure: Number of participants with escalated opioid use
timeFrame: Last 30 days at 2 months post-release vs. before incarceration (Phase I)
measure: Number of participants with escalated opioid use
timeFrame: Last 30 days at 3 months post-release vs. before incarceration (Phase II)
measure: Number of participants with escalated opioid use
timeFrame: Last 30 days at 6 months post-release vs. at 3 months post-release (Phase II)
measure: Number of use episodes of specific substances (e.g. opioids, marijuana, etc.)
timeFrame: Last 30 days at 2 months post-release (Phase I)
measure: Number of use episodes of specific substances (e.g. opioids, marijuana, etc.)
timeFrame: Last 30 days at 3 months post-release (Phase II)
measure: Number of use episodes of specific substances (e.g. opioids, marijuana, etc.)
timeFrame: Last 30 days at 6 months post-release (Phase II)
measure: Frequency of use of specific substances (e.g. opioids, marijuana, etc.)
timeFrame: Last 30 days at 2 months post-release (Phase I)
measure: Frequency of use of specific substances (e.g. opioids, marijuana, etc.)
timeFrame: Last 30 days at 3 months post-release (Phase II)
measure: Frequency of use of specific substances (e.g. opioids, marijuana, etc.)
timeFrame: Last 30 days at 6 months post-release (Phase II)
measure: Number of instances of overdose among non-opioid users
timeFrame: Last 30 days at 3 months post-release (Phase II)
measure: Number of instances of overdose among non-opioid users
timeFrame: Last 30 days at 6 months post-release (Phase II)
measure: Problematic substance use
timeFrame: Last 30 days at 6 months post-release (Phase II)
measure: Problematic substance use
timeFrame: Last 30 days at 3 months post-release (Phase II)
measure: Cost of ACRA Lite (medium intensity arm) per participant
timeFrame: 3 months post-release
measure: Cost of Enhanced ACRA (high intensity arm) per participant
timeFrame: 3 months post-release
measure: Cost of Education Workbook (low intensity arm) per participant
timeFrame: at release
Other outcomes:
measure: Participant attendance
timeFrame: 2 months post-release (Phase I)
measure: Participant attendance
timeFrame: 3 months post-release (Phase II)
measure: Participant satisfaction
timeFrame: 2 months post-release (Phase I)
measure: Participant satisfaction
timeFrame: 3 months post-release (Phase II)
Locations:
city: Olympia
country: United States
facility: Washington State Department of Children, Youth and Families
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Kym Ahrens, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Kevin Haggerty, MSW PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Understanding the epidemic. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed 3-2-2019.2018.
citation: 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.
citation: 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.
citation: Vaughn 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.
citation: Wojciechowski 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.
citation: Mulvey 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.
citation: Grisso T. Double jeopardy: adolescent offenders with mental disorders. Chicago: University of Chicago Press; 2004.
citation: 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.
citation: Cheng 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.
citation: Jones 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.
citation: Scott 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.
citation: The National Center for Addiction and Substance Abuse Research, Columbia University. Criminal Neglect: Substance Abuse, Juvenile Justice and The Children Left Behind. 2004.
citation: Mulvey EP. Highlights From Pathways to Desistance: A Longitudinal Study of Serious Adolescent Offenders. 2011.
citation: 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.
citation: Godley SH, Meyers RJ, Smith JE, et al. The Adolescent Community Reinforcement Approach for Adolescent Cannabis Users (Cannabis Youth Treatment (Cyt) Series) - Volume 4. Rockville, MD.
citation: Ahrens KR, Dubois DL, Garrison M, Spencer R, Richardson LP, Lozano P. Qualitative exporation of relationships with important non-parental adults in the lives of youth in foster care. Child Youth Serv Rev. 2011 Jun 1;33(6):1012-1023. doi: 10.1016/j.childyouth.2011.01.006.
citation: Godley MD, Passetti LL, Subramaniam GA, Funk RR, Smith JE, Meyers RJ. Adolescent Community Reinforcement Approach implementation and treatment outcomes for youth with opioid problem use. Drug Alcohol Depend. 2017 May 1;174:9-16. doi: 10.1016/j.drugalcdep.2016.12.029. Epub 2017 Feb 22.
citation: Godley SH, Hedges K, Hunter B. Gender and racial differences in treatment process and outcome among participants in the adolescent community reinforcement approach. Psychol Addict Behav. 2011 Mar;25(1):143-54. doi: 10.1037/a0022179.
citation: Godley SH, Hunter BD, Fernandez-Artamendi S, Smith JE, Meyers RJ, Godley MD. A comparison of treatment outcomes for adolescent community reinforcement approach participants with and without co-occurring problems. J Subst Abuse Treat. 2014 Apr;46(4):463-71. doi: 10.1016/j.jsat.2013.10.013. Epub 2013 Nov 11.
citation: Henderson CE, Wevodau AL, Henderson SE, Colbourn SL, Gharagozloo L, North LW, Lotts VA. An independent replication of the Adolescent-Community Reinforcement Approach with justice-involved youth. Am J Addict. 2016 Apr;25(3):233-40. doi: 10.1111/ajad.12366. Epub 2016 Mar 18.
citation: Meyers RJ, Roozen HG, Smith JE. The community reinforcement approach: an update of the evidence. Alcohol Res Health. 2011;33(4):380-8.
citation: Fleming C, Haggerty K. Process and Outcomes Evaluation of Keys to Success. 2013.
citation: Almirall D, Nahum-Shani I, Sherwood NE, Murphy SA. Introduction to SMART designs for the development of adaptive interventions: with application to weight loss research. Transl Behav Med. 2014 Sep;4(3):260-74. doi: 10.1007/s13142-014-0265-0.
citation: Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016 Oct;54(10):901-6. doi: 10.1097/MLR.0000000000000625.
citation: Pain in the nation: The drug, alcohol and suicide crises and the need for a national resilience strategy. 2017. (Accessed September 25, 2018, at http://www.paininthenation.org/assets/pdfs/TFAH-2017- PainNationRpt.pdf.)
citation: Centers for Disease Control and Prevention (CDC). CDC grand rounds: prescription drug overdoses - a U.S. epidemic. MMWR Morb Mortal Wkly Rep. 2012 Jan 13;61(1):10-3.
citation: Opioids. 2016. (at https://www.samhsa.gov/atod/opioids.)
citation: Case A, Deaton A. Mortality and morbidity in the 21st century. Brookings Pap Econ Act. 2017 Spring;2017:397-476. doi: 10.1353/eca.2017.0005.
citation: Opioid epidemic. 2016. (Accessed September 25, 2018, at https://www.atg.wa.gov/opioid-epidemic.)
citation: Schulenberg JE, Johnston LD, O'Malley PM, Bachman JG, Miech RA, Patrick ME. Monitoring the Future national survey results on drug use, 1975-2017: Volume II, College students and adults ages 19-55. Ann Arbor: Institute for Social Research, The University of Michigan; 2018.
citation: Jones CM. Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers - United States, 2002-2004 and 2008-2010. Drug Alcohol Depend. 2013 Sep 1;132(1-2):95-100. doi: 10.1016/j.drugalcdep.2013.01.007. Epub 2013 Feb 12.
citation: Banerjee G, Edelman EJ, Barry DT, Becker WC, Cerda M, Crystal S, Gaither JR, Gordon AJ, Gordon KS, Kerns RD, Martins SS, Fiellin DA, Marshall BD. Non-medical use of prescription opioids is associated with heroin initiation among US veterans: a prospective cohort study. Addiction. 2016 Nov;111(11):2021-2031. doi: 10.1111/add.13491. Epub 2016 Aug 23.
citation: Charak R, Ford JD, Modrowski CA, Kerig PK. Polyvictimization, Emotion Dysregulation, Symptoms of Posttraumatic Stress Disorder, and Behavioral Health Problems among Justice-Involved Youth: a Latent Class Analysis. J Abnorm Child Psychol. 2019 Feb;47(2):287-298. doi: 10.1007/s10802-018-0431-9.
citation: Perez NM, Jennings WG, Baglivio MT. A path to serious, violent, chronic delinquency: The harmful aftermath of adverse childhood experiences. Crime & Delinquency 2018;64:3-25.
citation: Abbott PJ. A review of the community reinforcement approach in the treatment of opioid dependence. J Psychoactive Drugs. 2009 Dec;41(4):379-85. doi: 10.1080/02791072.2009.10399776.
citation: Roozen HG, Boulogne JJ, van Tulder MW, van den Brink W, De Jong CA, Kerkhof AJ. A systematic review of the effectiveness of the community reinforcement approach in alcohol, cocaine and opioid addiction. Drug Alcohol Depend. 2004 Apr 9;74(1):1-13. doi: 10.1016/j.drugalcdep.2003.12.006.
citation: Carroll KM, Ball SA, Nich C, Martino S, Frankforter TL, Farentinos C, Kunkel LE, Mikulich-Gilbertson SK, Morgenstern J, Obert JL, Polcin D, Snead N, Woody GE; National Institute on Drug Abuse Clinical Trials Network. Motivational interviewing to improve treatment engagement and outcome in individuals seeking treatment for substance abuse: a multisite effectiveness study. Drug Alcohol Depend. 2006 Feb 28;81(3):301-12. doi: 10.1016/j.drugalcdep.2005.08.002. Epub 2005 Sep 28.
citation: Goossens I, Nicholls TL, Torchalla I, Brink J, de Ruiter C. The Perceived Impact of Trauma-Focused Research on Forensic Psychiatric Patients With Lifetime Victimization Histories. J Empir Res Hum Res Ethics. 2016 Oct;11(4):334-345. doi: 10.1177/1556264616670769. Epub 2016 Nov 25.
citation: Catalano RF, Park J, Harachi TW, Haggerty KP, Abbott RD, Hawkins JD. Mediating the effects of poverty, gender, individual characteristics, and external constraints on antisocial behavior: A test of the social development model and implications for developmental life-course theory. In: Farrington DP, ed. Advances in criminological theory: Vol 14. New Brunswick, NJ: Transaction; 2005:99-123.
citation: Catalano RF, Hawkins JD. The social development model: A theory of antisocial behavior. In: Hawkins JD, ed. Delinquency and crime: Current theories. New York: Cambridge University Press; 1996:149-97.
citation: Hirschi T. Causes of delinquency. Berkeley, CA: University of California Press; 1969.
citation: Bandura A. Social learning theory. Englewood Cliffs, NJ: Prentice Hall; 1977.
citation: Sutherland EH. Development of the theory [Private paper published posthumously]. In: Schuessler K, ed. Edwin Sutherland on analyzing crime. Chicago: University of Chicago Press; 1973:13-29.
citation: R.L. M. The current state of differential association theory. Crime and Delinquency 1988;34:277-306.
citation: Catalano RF, Gainey RR, Fleming CB, Haggerty KP, Johnson NO. An experimental intervention with families of substance abusers: one-year follow-up of the focus on families project. Addiction. 1999 Feb;94(2):241-54. doi: 10.1046/j.1360-0443.1999.9422418.x.
citation: Fleming CB, Catalano RF, Oxford ML, Harachi TW. A test of generalizability of the social development model across gender and income groups with longitudinal data from the elementary school developmental period. Journal of Quantitative Criminology 2002;18:423-39.
citation: Ford JD, Grasso DJ, Greene CA, Slivinsky M, DeViva JC. Randomized clinical trial pilot study of prolonged exposure versus present centred affect regulation therapy for PTSD and anger problems with male military combat veterans. Clin Psychol Psychother. 2018 Sep;25(5):641-649. doi: 10.1002/cpp.2194. Epub 2018 Apr 23.
citation: Ford JD, Chang R, Levine J, Zhang W. Randomized clinical trial comparing affect regulation and supportive group therapies for victimization-related PTSD with incarcerated women. Behav Ther. 2013 Jun;44(2):262-76. doi: 10.1016/j.beth.2012.10.003. Epub 2012 Nov 5.
citation: Ford JD, Grasso DJ, Hawke J, Chapman JF. Poly-victimization among juvenile justice-involved youths. Child Abuse Negl. 2013 Oct;37(10):788-800. doi: 10.1016/j.chiabu.2013.01.005. Epub 2013 Feb 19.
citation: Ford JD, Steinberg KL, Hawke J, Levine J, Zhang W. Randomized trial comparison of emotion regulation and relational psychotherapies for PTSD with girls involved in delinquency. J Clin Child Adolesc Psychol. 2012;41(1):27-37. doi: 10.1080/15374416.2012.632343.
citation: Ford JD, Steinberg KL, Zhang W. A randomized clinical trial comparing affect regulation and social problem-solving psychotherapies for mothers with victimization-related PTSD. Behav Ther. 2011 Dec;42(4):560-78. doi: 10.1016/j.beth.2010.12.005. Epub 2011 Apr 16.
citation: www.wsipp.wa.gov/BenefitCost?topicId=1 Accessed 3-2-2019.