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.

项目摘要 青少年和年轻人使用非处方阿片类药物在我国很流行， 死亡人数在上升。司法环境中的青少年和年轻人（AYAJS）的犯罪率最高， 阿片类药物使用障碍（OUD），全国发病率接近20%。大多数AYAJS从事有问题的 非阿片类物质使用，这是OUD的关键风险因素。非阿片类物质使用障碍（SUD） 和OUD，反过来，是随后重新参与青少年或犯罪的两个最重要的预测因素 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 青少年社区强化方法与断言持续护理（ACRA/ACC）。 多项研究已经确定了ACRA/ACC在减少SUD方面的有效性;但是没有一项研究评估了 这是一项预防OUD的战略。SUD在AYAJS中非常常见且昂贵;因此ACRA/ACC- 的方法可能是有效的和成本效益的OUD预防策略，为这一群体。 然而，我们需要确定基于ACRA/ACC的OUD预防干预的最佳强度， 有和没有非阿片类SUD的AYAJS，因为这些群体可能有不同的预防需求。我们将 使用序贯多重分配随机试验（SMART）构建高质量的自适应 干预措施（AIs）包含基于ACRA/ACC的不同强度水平的OUD预防策略， 年轻人和非年轻人。在我们为期2年的UG 3阶段，我们将共同规划SMART实验，即： 完成基础设施、招募、干预和数据收集程序; 在UH 3全面试验后可持续地实施有效干预措施（UG 3目标1）。我们会进行 一个有40名AYAJS的试点项目，以评估协议和程序、招募、参与的可行性， 保留策略，预计全面审判（UG 3目标2）。在我们为期3年的UH 3阶段，我们将进行SMART 来自所有WSJR机构的430名年龄在16-25岁的AYAJS的试验，以评估基于ACRA/ACC的OUD预防 在南部非洲发展共同体和非南部非洲发展共同体青年中采取不同强度的干预措施（UH 3目标1）。我们会自我管理- 报告基线、1、3和6个月的电子调查，以收集主要结局的成本和结局数据 （使用的开始和升级，以使用任何物质的天数和频率衡量）和 次要结局（使用特定物质（包括阿片类药物等）的天数/频率）;我们 将使用行政数据来衡量累犯率。我们UH 3的目标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的合作程度以及其严格和 务实的SMART设计。这也是高影响，因为它很可能防止OUD的最 我们国家的弱势青年群体。