Preventing OUD in Justice-Involved Youth

NCT ID: NCT04901312

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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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

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Substance Use Disorders Recidivism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential Multiple Assignment Randomized Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The Outcomes Assessor (data collection team) will not be aware of the participant's study arm when they collect survey data.

Study Groups

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Enhanced A-CRA (E-ACRA)

Higher intensity

Group Type EXPERIMENTAL

Adolescent Community Reinforcement Approach

Intervention Type 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.

Assertive Continuing Care

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

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

Opioid Education Workbook

Intervention Type 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.

Assertive Community Support (ACS)

Lower intensity

Group Type EXPERIMENTAL

Adolescent Community Reinforcement Approach

Intervention Type 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.

Assertive Continuing Care

Intervention Type 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.

Motivational Interviewing

Intervention Type BEHAVIORAL

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

Opioid Education Workbook

Intervention Type 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.

Interventions

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Adolescent Community Reinforcement Approach

The Adolescent Community Reinforcement Approach (A-CRA) is a developmentally-appropriate behavioral treatment for youth and young adults ages 12 to 24 years old with substance use disorders. A-CRA seeks to increase the family, social, and educational/vocational reinforces to support recovery. This intervention has been implemented in outpatient, intensive outpatient, and residential treatment settings. A-CRA includes guidelines for three types of sessions: individuals alone, parents/caregivers alone, and individuals and parents/caregivers together. According to the individual's needs and self-assessment of happiness in multiple life areas, clinicians choose from a variety of A-CRA procedures that address, for example, problem-solving skills to cope with day-to-day stressors, communication skills, and active participation in positive social and recreational activities with the goal of improving life satisfaction and eliminating alcohol and substance use problems.

Intervention Type BEHAVIORAL

Assertive Continuing Care

Assertive Continuing Care (ACC) uses Community Reinforcement Approach (CRA) procedures, home visits, and case management for individuals following an initial substance use treatment episode. It stresses rapid initiation of services after discharge from residential, intensive outpatient, or regular outpatient treatment in order to promote recovery and prevent relapse.

Intervention Type BEHAVIORAL

Trauma Affect Regulation Guide for Education and Therapy

Trauma Affect Regulation: Guide for Education and Therapy is a psychosocial intervention for traumatized adolescents, adults, and families, and for workforce and organizational responses to secondary/vicarious traumatization. T4, the 4-session version, provides education about the impact of complex traumatic stress on the brain's stress response system, and strengths-based practical skills for re-setting the trauma-related alarm/survival reactions that occur in complex PTSD.

Intervention Type BEHAVIORAL

Motivational Interviewing

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

Intervention Type BEHAVIORAL

Opioid Education Workbook

A digital workbook designed to be completed on a computer in about 2 hours. Topics include opioid use, opioid use disorder, and prevention and treatment of opioid overdose.

Intervention Type OTHER

Other Intervention Names

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A-CRA ACRA ACC T4 TARGET MI Education

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Washington State Department of Children, Youth and Families

UNKNOWN

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kym Ahrens

Associate Professor, Division of Adolescent Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kym Ahrens, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Kevin Haggerty, MSW PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Washington State Department of Children, Youth and Families

Olympia, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katie Albertson

Role: CONTACT

206-568-5546

Facility Contacts

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Robert Hopkins

Role: primary

360-701-4615

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Related Links

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Other Identifiers

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UG3DA050189

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-131-DCYF

Identifier Type: -

Identifier Source: org_study_id

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