Preventing OUD in Justice-Involved Youth

NCT04901312 | Unknown DMC

• 2 other identifiers: 2019-131-DCYFUG3DA050189
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

  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

Secondary Outcomes (17)

• Number of new opioid users

  6 months post-release (Phase II)

• Number of participants with escalated opioid use

  Last 30 days at 2 months post-release vs. before incarceration (Phase I)

• Number of participants with escalated opioid use

  Last 30 days at 3 months post-release vs. before incarceration (Phase II)

• Number of participants with escalated opioid use

  Last 30 days at 6 months post-release vs. at 3 months post-release (Phase II)

• Number of use episodes of specific substances (e.g. opioids, marijuana, etc.)

  Last 30 days at 2 months post-release (Phase I)

Other Outcomes (4)

• Participant attendance

  2 months post-release (Phase I)

• Participant attendance

  3 months post-release (Phase II)

• Participant satisfaction

  2 months post-release (Phase I)

Study Arms (2)

Enhanced A-CRA (E-ACRA)

EXPERIMENTAL

Higher intensity

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

Behavioral: Adolescent Community Reinforcement Approach; Behavioral: Assertive Continuing Care; Behavioral: Motivational Interviewing; Other: Opioid Education Workbook

Interventions

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.

Also known as: A-CRA, ACRA

Assertive Community Support (ACS); Enhanced A-CRA (E-ACRA)

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.

Also known as: ACC

Assertive Community Support (ACS); Enhanced A-CRA (E-ACRA)

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.

Also known as: T4, TARGET

Enhanced A-CRA (E-ACRA)

Motivational Interviewing BEHAVIORAL

Motivational interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change.

Also known as: MI

Assertive Community Support (ACS); Enhanced A-CRA (E-ACRA)

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.

Also known as: Education

Assertive Community Support (ACS); Enhanced A-CRA (E-ACRA)

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator
• Washington State Department of Children, Youth and Families: collaborator
• Michigan State University: collaborator
• RTI International: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Washington State Department of Children, Youth and Families

Olympia, Washington, 98504, United States

RECRUITING

Related Publications (57)

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Related Links

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

MeSH Terms

Conditions

Substance-Related Disorders; Recidivism; Opioid-Related Disorders

Interventions

Educational Status; Therapeutics; Motivational Interviewing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Criminal Behavior; Behavior; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kym Ahrens, MD MPH

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• Kevin Haggerty, MSW PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Albertson

CONTACT

206-568-5546; katie.albertson@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcomes Assessor (data collection team) will not be aware of the participant's study arm when they collect survey data.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Adolescent Medicine

Model Details: Sequential Multiple Assignment Randomized Trial

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: May 25, 2021
• Study Start: January 20, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: 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.

Locations

US (1)