Recruiting

Observational Study

Sponsor:

Seattle Children's Hospital

Code:

NCT04901312

Conditions

Substance Use Disorders

Recidivism

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Interventions

Adolescent Community Reinforcement Approach

Assertive Continuing Care

Trauma Affect Regulation Guide for Education and Therapy

Motivational Interviewing

Opioid Education Workbook

Study Details

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

Study ID

NCT04901312

Start date

Jan 20, 2021

Status verified date

Oct, 2022

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

215 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Enhanced A-CRA (E-ACRA)

Higher intensity

experimental: Assertive Community Support (ACS)

Lower intensity

Interventions

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.

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.

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.

Motivational Interviewing

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

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.

Primary outcome measure

  • Number of substance use episodes [ Time Frame: Last 30 days at 2 months post-release (Phase I) ]
  • Number of substance use episodes [ Time Frame: Last 30 days at 3 months post-release (Phase II) ]
  • Number of substance use episodes [ Time Frame: Last 30 days at 6 months post-release (Phase II) ]
  • Frequency of substance use episodes [ Time Frame: Last 30 days at 2 months post-release (Phase I) ]
  • Frequency of substance use episodes [ Time Frame: Last 30 days at 3 months post-release (Phase II) ]
  • Frequency of substance use episodes [ Time Frame: Last 30 days at 6 months post-release (Phase II) ]
  • Rate of Recidivism [ Time Frame: 12 months post-release ]
  • Rate of Recidivism [ Time Frame: 18 months post-release ]

Central Contacts and Locations

Central contacts

Katie Albertson

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

Locations

Washington State Department of Children, Youth and Families

Recruiting

Olympia, Washington, United States, 98504

Contacts

Robert Hopkins

360-701-4615robert.hopkins@dcyf.wa.gov

Principal Investigator:

Ted Ryle, MSW MA

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Oct 27, 2022

Last verified

Oct, 2022

Keywords

  • Juvenile Rehabilitation
  • Adolescent
  • Young Adult
  • Juvenile Justice
  • Opioids
  • Opioid Use Disorder
  • Substance Use
  • Prevention
  • Recidivism
  • Substance Use Disorder
  • Cost Effectiveness
  • Benefit Cost Analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2022-10-27.