Using SMART Design to Identify an Effective and Cost-Beneficial Approach to Preventing OUD in Justice-Involved Youth

使用 SMART 设计确定有效且具有成本效益的方法，以防止参与司法的青少年出现 OUD

• 批准号: 10441666
• 负责人: KYM R AHRENS
• 金额: $ 337.04万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10441666
• 关键词: Address; Adolescent; Adolescent and Young Adult; Assertiveness; Award; Back; Biometry; Caring; Clinical Trials; Collaborations; Communities; Cost Analysis; Cost Savings; Cost-Benefit Analysis; Costs and Benefits; Country; Criminal Justice; Custom; Data; Data Collection; Data Reporting; Economics; Effectiveness; Ensure; Epidemic; Evidence based intervention; Frequencies; Future; Grant; Health; Infrastructure; Institution; Interruption; Intervention; Justice; Measures; Methods; Modeling; Opioid; Outcome; Overdose; Participant; Patient Self-Report; Pediatric Hospitals; Phase; Population; Prevention; Prevention strategy; Procedures; Protocols documentation; Psychological reinforcement; Recording of previous events; Rehabilitation therapy; Research Personnel; Resources; Rewards; Risk; Risk Factors; Sampling; Self Administration; Sequential Multiple Assignment Randomized Trial; Substance Use Disorder; Surveys; System; Trauma; Universities; University Hospitals; Urine; Washington; Youth; adaptive intervention; aged; base; contingency management; cost; cost effective; cost effectiveness; cost outcomes; disorder prevention; effective intervention; effectiveness evaluation; experimental study; high risk; improved; innovation; motivational enhancement therapy; non-opioid analgesic; opioid use; opioid use disorder; prevent; preventive intervention; primary outcome; programs; recidivism; recruit; reduced substance use; retention rate; secondary outcome; social; substance use; substance use prevention; treatment as usual; trial design

PROJECT SUMMARY Non-prescription opiate use in adolescents and young adults is epidemic in our country and overdose-related fatalities are rising. Adolescents and young adults in justice settings (AYAJS) have some of the highest rates of opioid use disorder (OUD), with national rates approaching 20%. The majority of AYAJS 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. Seattle Children’s Hospital (SCH), University of Washington (UW), and Washington State Juvenile Rehabilitation (WSJR) will collaboratively evaluate 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 have evaluated it as an OUD prevention strategy. SUD is incredibly common and costly among AYAJS; thus ACRA/ACC- based approaches are likely to be effective and cost-beneficial OUD prevention strategies for this group. However, we need 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. We will use Sequential Multiple Assignment Randomized Trial (SMART) to construct high-quality adaptive interventions (AIs) containing ACRA/ACC-based OUD prevention strategies of different intensity levels among SUD and non-SUD youth. In our 2-year UG3 phase, we will collaboratively plan for a SMART experiment, i.e.: finalize infrastructure, recruitment, intervention, and data collection procedures; and create infrastructure for sustainable future implementation of effective interventions after the UH3 full trial (UG3 Aim 1). We will conduct a pilot with 40 AYAJS to assess feasibility of protocols and procedures, recruitment, engagement, and retention strategies in anticipation of full trial (UG3 Aim 2). In our 3-year UH3 phase, we will conduct a SMART trial with 430 AYAJS aged 16-25 from all WSJR institutions to evaluate ACRA/ACC-based OUD prevention interventions of various intensity levels among SUD and non-SUD youth (UH3 Aim 1). We will administer self- report electronic surveys at baseline, 1, 3 & 6 months to collect cost and outcomes data on primary outcomes (initiation and escalation of use measured by number of days and frequency of use of any substances) and secondary outcomes (number of days/frequency of use of specific substances including opioids, others); we will use administrative data to measure recidivism. Our UH3 Aim 2 will be to conduct comprehensive cost analyses to estimate the resources required to implement our ACRA-based interventions. Our proposal is responsive to the RFA, innovative in its degree of partnership with WSJR as well as in its rigorous and pragmatic SMART design. It is also high impact in that it is highly likely to prevent OUD for one of the most vulnerable youth populations in our country.

项目总结 非处方阿片类药物在青少年中的使用在我国很流行，并与过量用药有关 死亡人数正在上升。在司法环境中的青少年和年轻人(AYAJS)有一些最高的 阿片类药物使用障碍(OUD)，全国比率接近20%。AYAJS的大多数人从事有问题的 非阿片类物质的使用，这是OUD的一个关键风险因素。非阿片类物质使用障碍(SUDS) 和OUD，反过来，是两个最重要的预测因素，随后再次卷入青少年或犯罪 司法系统。西雅图儿童医院(SCH)、华盛顿大学(UW)和华盛顿州 青少年康复(WSJR)将合作评估不同强度的OUD预防干预措施 基于积极持续关怀的青少年社区强化方法(ACRA/ACC)。 多项研究证实了ACRA/ACC在减少SUD方面的有效性；然而，还没有一项研究对其进行评估 将其作为一种良好的预防策略。在AYAJS中，SUD非常普遍，成本也非常高；因此，ACRA/ACC- 以此为基础的方法可能是这一群体的有效和成本效益较高的预防策略。 然而，我们需要确定基于ACRA/ACC的OUD预防干预的最佳强度 使用和不使用非阿片类药物的AYAJS，因为这些群体可能有不同的预防需求。我们会 使用序贯多分配随机试验(SMART)构建高质量的自适应 干预措施(AIS)，其中包含不同强度水平的基于ACRA/ACC的OUD预防战略 苏德青年和非苏德青年。在我们为期两年的UG3阶段，我们将协作规划智能实验，即： 最终确定基础设施、招聘、干预和数据收集程序；并为 在UH3全面试验(UG3目标1)之后可持续地未来实施有效干预措施。我们将进行 有40名AYAJ的飞行员，以评估协议和程序、招聘、接洽和 期待全面试验的保留策略(UG3目标2)。在我们为期3年的UH3阶段，我们将进行SMART 对来自所有WSJR机构的430名16-25岁的AYAJS进行试验，以评估基于ACRA/ACC的OUD预防 在SUD和非SUD青年中进行不同强度的干预(UH3目标1)。我们将自行管理 在基线、1个月、3个月和6个月时报告电子调查，以收集关于主要结果的成本和结果数据 (开始和升级使用任何物质的天数和频率)和 次要结果(包括阿片类药物等特定物质的使用天数/频率)；我们 将使用行政数据来衡量累犯率。我们的UH3目标2将是进行综合成本 分析，以估计实施我们基于ACRA的干预措施所需的资源。我们的建议是 响应RFA，在与WSJR的伙伴关系程度上以及在其严格和 实用的智能设计。它的影响也很大，因为它极有可能阻止OUD成为最大的 我国的弱势青年群体。