Department of Behavioral, Social, and Health Education Sciences, Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Atlanta, GA, 30322, USA.
Cherokee Nation Behavioral Health, 19600 N. Ross St, Tahlequah, OK, 74464, USA.
Trials. 2022 Feb 23;23(1):175. doi: 10.1186/s13063-022-06096-0.
The national opioid crisis has disproportionately burdened rural White populations and American Indian/Alaska Native (AI/AN) populations. Therefore, Cherokee Nation and Emory University public health scientists have designed an opioid prevention trial to be conducted in rural communities in the Cherokee Nation (northeast Oklahoma) with AI and other (mostly White) 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 Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral, as implemented in our established Connect intervention protocol-will be integrated with skill-based training for adults to strengthen social support for youth and also with strategic media. Furthermore, we will test systems for sustained implementation within existing organizational structures of the Cherokee Nation and local schools and communities. This study protocol describes the cluster randomized trial, designed to measure implementation and evaluate the effectiveness on primary and secondary outcomes.
Using a cluster randomized controlled design and constrained randomization, this trial will allocate 20 high schools and surrounding communities to either an intervention or delayed-intervention comparison condition. With a proposed sample of 20 high schools, all enrolled 10th grade students in fall 2021 (ages 15 to 17) will be eligible for participation. During the trial, we will (1) implement interventions through the Cherokee Nation and measure implementation processes and fidelity, (2) measure opioid and other drug use and secondary outcomes every 6 months among a cohort of high school students followed over 3 years through their transition out of high school, (3) test via a cluster randomized trial the effect of the integrated CMCA-Connect intervention, and (4) analyze implementation costs. Primary outcomes include the number of days during the past 30 days of (1) any alcohol use, (2) heavy alcohol use (defined as having at least four, among young women, or five, among young men, standard alcoholic drinks within a couple of hours), (3) any marijuana use, and (4) prescription opioid misuse (defined as "without a doctor's prescription or differently than how a doctor or medical provider told you to use it").
This trial will expand upon previous research advancing the scientific evidence regarding prevention of opioid and other drug misuse during the critical developmental period of late adolescent transition to young adulthood among a sample of American Indian and other youth living within the Cherokee Nation reservation.
ClinicalTrials.gov NCT04839978 . Registered on April 9, 2021. Version 4, January 26, 2022.
全国性的阿片类药物危机给农村白人人口和美国印第安人/阿拉斯加原住民（AI/AN）人口带来了不成比例的负担。因此，切罗基族和埃默里大学的公共卫生科学家设计了一项阿片类药物预防试验，该试验将在切罗基族（俄克拉荷马州东北部）的农村社区进行，涉及 AI 和其他（主要是白人）青少年和年轻成年人。我们的目标是实施和评估一种基于理论的、综合的多层次社区干预措施，旨在预防阿片类药物和其他药物滥用的发生和升级。两种不同的干预方法——社区组织，如我们现有的“社区动员促进变革和行动”（CMCA）干预方案中实施的方法，以及在我们现有的“连接”干预方案中实施的普及性学校基础的简短干预和转介——将与成人的技能培训相结合，以加强对青年的社会支持，同时还将结合战略媒体。此外，我们将测试在切罗基族现有的组织结构和当地学校和社区内持续实施的系统。本研究方案描述了一项集群随机试验，旨在衡量实施情况并评估主要和次要结果的有效性。
本试验采用集群随机对照设计和约束随机化，将 20 所高中及其周边社区分配到干预组或延迟干预比较组。在一项拟议的 20 所高中样本中，所有 2021 年秋季入学的 10 年级学生（年龄在 15 至 17 岁之间）都有资格参加。在试验期间，我们将：（1）通过切罗基族实施干预措施，并测量实施过程和保真度；（2）在 3 年的时间里，通过高中毕业后过渡的学生队列，每 6 个月测量一次阿片类药物和其他药物的使用情况以及次要结果；（3）通过集群随机试验测试综合 CMCA-Connect 干预的效果；（4）分析实施成本。主要结果包括过去 30 天内以下情况的天数：（1）任何酒精使用；（2）重度酒精使用（定义为年轻女性中至少有四个，年轻男性中至少有五个，在几个小时内喝了标准的酒精饮料）；（3）任何大麻使用；（4）处方阿片类药物滥用（定义为“没有医生的处方，或与医生或医疗提供者告诉你的使用方式不同”）。
本试验将在以前的研究基础上进一步推进科学证据，即在关键的青少年晚期向年轻成人过渡期间，预防美国印第安人和其他生活在切罗基族保留地的年轻人中阿片类药物和其他药物的滥用。
ClinicalTrials.gov NCT04839978。于 2021 年 4 月 9 日注册。版本 4，2022 年 1 月 26 日。
