跳至主要内容
临床试验/NCT04678960
NCT04678960已完成不适用

Preventing Opioid Use Among Justice-involved Youth as They Transition to Adulthood: Leveraging Safe Adults (LeSA)

Texas Christian University22 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
22
主要终点
Youth days to opioid (and other substance use) initiation

研究概览

简要总结

Across the US, substance use is a significant public health concern, with juvenile justice (JJ)-involved youth representing a particularly vulnerable population. The current study proposes to adapt and test an intervention Trust-based Relational Intervention® (TBRI®) for preventing initiation and/or escalation of opioid misuse among older adolescents involved in the JJ system. Successful completion of study aims will provide information on TBRI's utility for older JJ adolescents, barriers and facilitators of sustainment, and provide training and implementation support for sustainment in participating facilities.

详细描述

Across the US, substance use (SU) is a significant public health concern, with an estimated 11.1 million misusing prescription opioids. Rates of opioid use disorders (OUDs) have increased exponentially, with 60% of overdoses attributed to heroin and illicit synthetics (such as Fentanyl). Although opioid use among youth is low compared to adults, experimentation and regular use increases later in adolescence as youth transition to adulthood. Juvenile justice (JJ)-involved youth represent a particularly vulnerable population, as they often experience mental health disorders, dysfunctional family/social relationships, and complex trauma, placing them at greater risk for SU and substance use disorders (SUDs). To ensure that these youth do not become another opioid statistic, innovative and effective prevention interventions are needed. The investigators propose to adapt and test an intervention for preventing initiation and/or escalation of opioid misuse among older JJ-involved adolescents. The target enrollment group will be youth aging out of JJ (15-18 years at study enrollment) who are transitioning to their communities after a period of detainment in a secure treatment or correctional facility. Trust-based Relational Intervention® (TBRI®; a relational, attachment-based intervention that promotes emotional regulation through interaction with responsive adults) will be adapted as a prevention intervention targeting youth at risk for SU (especially non-medical use of opioids). Safe adults (e.g., parent/guardian, extended family member) will be trained in behavior management techniques for empowering youth to appropriately express their needs, connecting them with others in pro-social ways, and correcting or reshaping undesirable behavior. The proposed Effectiveness/Implementation study will examine both the effectiveness of TBRI for preventing opioid misuse and the comparative utility of three support formats: (1) TBRI Training only, (2) TBRI Training + Structured Coaching, or (3) TBRI Training + Responsive Coaching (triggered by the youth's need/risk). A total of 360 youth/safe adult dyads will be recruited from 9 participating JJ facilities over a 3-year period, and followed for 18 months post-release (15 youth-adult dyads/year per facility). This design enables a comparison of TBRI versus Standard Reentry Practice (SRP; using a stepped-wedge design where each facility serves as its own control) plus a randomized control trial comparing 3 TBRI support formats. This study will also examine barriers and facilitators of TBRI sustainment. Ninety JJ staff (10 from each agency) will provide input annually via focus groups and surveys. TCU will work with administrators and staff at each JJ facility to implement a sustainment plan, which will include developing in-house TBRI expertise (i.e., staff training and implementation assistance). Successful completion of study aims will provide a test of the adapted intervention and will facilitate sustainment by providing training and implementation support to participating facilities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • For the effectiveness component,
  • Youth ages 15-18 at study enrollment
  • Being disposed to community supervision (i.e., probation) following a minimum of 2 months in the secure residential JJ facility
  • No indication of active suicide risk
  • Being able to identify one safe adult that is willing to participate in the study.
  • For the implementation component:
  • All staff with direct care or supervisory responsibilities within and outside the facilities (i.e., officers supervising youth after release) working with TCU on the LeSA project.

排除标准

  • Youth outside the age range described above
  • Active suicide risk at the time of recruitment

结局指标

主要结局

Youth days to opioid (and other substance use) initiation

时间窗: 15 months

Initiation to opioid and other substance use (e.g., alcohol, marijuana, methamphetamine) over 15 months follow-up in days, measured by the scale of Timeline follow-back, Substance Use Involvement (i.e., during the past 30 days, how many days did you use alcohol or drugs; developed by the HEAL Prevention Cooperative), urinalysis results. Scores: 0-450 days; a higher score indicating a better outcome.

Youth months to opioid (and other substance use) initiation

时间窗: 15 months

Initiation to opioid and other substance use over 15 months follow-up in months, monthly check-ins (any opioid use; any alcohol, other drug use in the past month). Scores: 0-15 months; a higher score indicating a better outcome.

Youth substance use severity

时间窗: 15 months

Opioid use and other substance use (e.g., alcohol, marijuana, methamphetamine) over 15 months; measured by TCU Drug Screen 5 and TCU Drug Screen 5 - Opioid Supplement. Scores: 0-11, a higher score indicating a worse outcome.

次要结局

  • Self-regulation (youth) - emotion regulation(15 months)
  • Anxiety (both youth and caregivers)(15 months)
  • Depression (both youth and caregivers)(15 months)
  • Self-efficacy (youth)(15 months)
  • Behavioral problems (youth)(15 months)
  • Self-regulation (youth) - positive and negative urgency(15 months)
  • Self-regulation (youth) - executive functioning(15 months)
  • Social exposure to alcohol, marijuana, heroin, and prescription opioids (youth)(15 months)
  • Prosocial behavior (youth)(15 months)
  • Self-regulation (youth) - delayed discounting(15 months)
  • Pain (both youth and caregivers)(15 months)
  • Youth and caregiver relationship(15 months)
  • Monthly check-ins on behavioral misconduct (youth)(15 months)
  • Monthly check-ins on anxiety, depression, and stress in the relationship with caregiver/safe adult (youth)(15 months)
  • Family relationship(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (22)

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