Study protocol for a cluster randomized trial of a school, family, and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation.
Study protocol for a cluster randomized trial of a school, family, and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation.
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DOI：
10.1186/s13063-022-06096-0
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发表时间：
2022-02-23
期刊：
影响因子：
2.5
通讯作者：
Wagenaar AC
中科院分区：
文献类型：
--
作者：
Komro KA;Kominsky TK;Skinner JR;Livingston MD;Livingston BJ;Avance K;Lincoln AN;Barry CM;Walker AL;Pettigrew DW;Merlo LJ;Cooper HLF;Wagenaar AC
全国性的阿片类药物危机对农村白人人口和美国印第安人/阿拉斯加原住民（AI/AN）人口造成了不成比例的负担。因此，切罗基民族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，将在切罗基民族（俄克拉荷马州东北部）的农村社区与AI和其他（主要是白人）青少年和年轻人进行。我们的目标是实施和评估一个基于理论的综合多层次社区干预，旨在防止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，如我们已建立的社区动员变革和行动（CMCA）干预方案所实施的，以及普遍的基于学校的简短干预和转诊，如我们已建立的连接干预方案所实施的——将与成人技能培训相结合，以加强对青年的社会支持，并与战略媒体相结合。此外，我们将测试在切罗基族和当地学校和社区现有组织结构内持续实施的系统。本研究方案描述了集群随机试验，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所高中和周边社区分配到干预或延迟干预的比较条件下。以20所高中为样本，所有2021年秋季入学的10年级学生（15至17岁）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)每6个月对一组高中学生进行一次阿片类药物和其他药物使用和次要结果的测量，随访超过3年，直到高中毕业；(3)通过聚类随机试验测试综合cca - connect干预措施的效果；(4)分析实施成本。主要结果包括过去30天内(1)任何酒精使用的天数，(2)重度酒精使用（定义为年轻女性在几个小时内至少饮用四杯或年轻男性五杯标准酒精饮料），(3)任何大麻使用，以及(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”）。这项试验将在先前研究的基础上进行扩展，以生活在切罗基族保留地的美国印第安人和其他青年为样本，在青少年晚期过渡到青年期的关键发育时期预防阿片类药物和其他药物滥用的科学证据。ClinicalTrials.gov NCT04839978。注册于2021年4月9日。第4版，2022年1月26日，在线版本包含补充材料，可在10.1186/s13063-022-06096-0获得。
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 The online version contains supplementary material available at 10.1186/s13063-022-06096-0.
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