Community Randomized Trial in the Cherokee Nation: CONNECT and CMCA for Preventing Drug Misuse among Older Adolescents

摘要 国家公共卫生阿片类药物危机给农村白人人口带来了不成比例的负担， 不成比例地加重了美国印第安人的负担。因此，切罗基族(CN)和埃默里 大学公共卫生科学家设计了一项阿片类药物预防试验，将在高危农村地区进行 在CN(俄克拉何马州东北部)有白人和美国印第安人青少年和年轻人的社区。 我们的目标是实施和评估一个基于理论的、综合的、多层次的社区干预设计 防止阿片类药物和其他药物滥用的发生和升级。两种截然不同的干预方法- 按照我们制定的CMCA干预协议实施的社区组织，以及普遍的学校- 基于我们已建立的连接干预协议-Will中实施的简短干预和转介 扩大和整合，以进一步加强其在预防和减少阿片类药物滥用方面的效果。这个 CMCA和CONNECT干预措施最初是针对青少年饮酒而设计的，但 然而，对其他药物的使用，包括处方药的滥用，显示出显著的有益影响。 拟议的研究将：(1)进一步改进干预措施的设计，更加注重阿片类药物，(2) 在社区随机试验中测试扩展的集成版本，以及(3)设计和测试新系统 在切诺基民族的现有结构内持续执行。建立在现有的基础上 预防科学证据，我们的研究将回应关于阿片类药物滥用预防的证据空白 在高危青少年中，在美国、印度和其他农村青年中过渡到青壮年。我们的 前一次试验是与切诺基民族合作进行的，以年满18岁的年轻人结束； 拟议中的新试验将进一步推进有关吸引年轻人参与的战略的科学 高中毕业后的过渡。在UG3规划阶段，我们将(1)扩展和整合基于理论的 青春期后期至青春期关键发育期多层次预防干预方案 成年期，(2)制定实施、近端和阿片类药物及其他药物使用结果措施，以及(3) 为启动审判做好准备。在UH3试验阶段，我们将(1)通过以下方式实施干预 切罗基国家和衡量执行进程和忠诚度，(2)衡量近端和阿片类药物和 来自16所学校的10年级学生每6个月进行一次其他药物使用结果的跟踪调查 在他们高中毕业的三年多时间里，(3)通过社区随机试验测试了这种效果 综合CMCA-CONNECT干预的实施成本和成本效益分析。 这项试验将在我们先前研究的基础上进行扩展，以实质性地推进关于以下方面的科学证据 青春期后期阿片类药物及其他药物滥用的预防 过渡到青壮年。

Abstract The national public health opioid crisis has disproportionately burdened rural white populations, and disproportionately burdened American Indian populations. Therefore, the Cherokee Nation (CN) and Emory University public health scientists have designed an opioid prevention trial to be conducted in at-risk rural communities in the CN (in northeast Oklahoma) with white and American Indian adolescents and young adults. Our goal is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. Two distinct intervention approaches— community organizing as implemented in our established CMCA intervention protocol, and universal school- based brief intervention and referral as implemented in our established CONNECT intervention protocol—will be expanded and integrated to further enhance their effects in preventing and reducing opioid misuse. The CMCA and CONNECT interventions were originally designed to target adolescent alcohol use, but nevertheless showed significant beneficial effects on use of other drugs, including prescription drug misuse. The proposed study will: (1) further improve the design of the interventions with increased focus on opioids, (2) test the expanded, integrated versions in a community randomized trial, and (3) design and test new systems for sustained implementation within existing structures of the Cherokee Nation. Building upon the extant prevention science evidence, our study will respond to a gap in evidence concerning opioid misuse prevention among at-risk adolescents transitioning to young adulthood among American Indian and other rural youth. Our previous trial, conducted in partnership with the Cherokee Nation ended with youth attaining age 18; the proposed new trial will additionally advance the science regarding strategies to engage young adults as they transition beyond high school. During the UG3 planning phase we will (1) expand and integrate a theory-based multi-level preventive intervention package for the critical developmental period of late adolescence to young adulthood, (2) develop implementation, proximal and opioid and other drug use outcome measures, and (3) prepare for the initiation of the trial. During the UH3 trial phase we will (1) implement interventions through Cherokee Nation and measure implementation processes and fidelity, (2) measure proximal and opioid and other drug use outcomes every six months among a cohort of 10th grade students from 16 schools followed over three years through their transition out of high school, (3) test via a community randomized trial the effect of the integrated CMCA-CONNECT intervention, and (4) analyze implementation costs and cost-effectiveness. This trial will expand upon our previous research to substantially advance the scientific evidence regarding prevention of opioid and other drug misuse during the critical developmental period of late adolescent transitions to young adulthood.