跳至主要内容
临床试验/NCT04901312
NCT04901312招募中不适用

Identifying an Effective and Cost Beneficial Approach to Preventing OUD in Justice-Involved Youth

Seattle Children's Hospital2 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
215
试验地点
2
主要终点
Rate of Recidivism

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Rate of Recidivism

时间窗: 18 months post-release

Convictions in either the juvenile or adult justice system for offenses within an 18-month period

Frequency of substance use episodes

时间窗: 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.

Number of substance use episodes

时间窗: 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.

次要结局

  • Cost of Enhanced ACRA (high intensity arm) per participant(3 months post-release)
  • Number of use episodes of specific substances (e.g. opioids, marijuana, etc.)(Last 30 days at 6 months post-release (Phase II))
  • Number of new opioid users(6 months post-release (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))
  • Frequency of use of specific substances (e.g. opioids, marijuana, etc.)(Last 30 days at 6 months post-release (Phase II))
  • Number of instances of overdose among non-opioid users(Last 30 days at 6 months post-release (Phase II))
  • Cost of ACRA Lite (medium intensity arm) per participant(3 months post-release)
  • Problematic substance use(Last 30 days at 3 months post-release (Phase II))
  • Cost of Education Workbook (low intensity arm) per participant(at release)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kym Ahrens

Associate Professor, Division of Adolescent Medicine

Seattle Children's Hospital

研究点 (2)

Loading locations...

相似试验