Protocol for a cluster randomized trial of a school, family and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation
Authors: Komro Kelli A. , Kominsky Terrence K. , Skinner Juli R. , Livingston Melvin D. , Livingston Bethany J. , Avance Kristin , Lincoln Ashley N. , Barry Caroline M. , Walker Andrew L. , Pettigrew Dallas W. , Merlo Lisa J. , Cooper Hannah L.F. , Wagenaar Alexander C. 
Published: July 2021

Abstract
Background: 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 expanded, integrated, and supported with skill-based training to strengthen social support and strategic media to further enhance effects in preventing and reducing drug misuse. This new trial will build on our previous trials, improving design and implementation of the interventions with increased focus on opioids and other drugs. Further, 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 effectiveness on primary and secondary outcomes.Methods: 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 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 six months among a cohort of high school students followed over three 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. Discussion: 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.Trial registration: ClinicalTrials.gov, NCT04839978. Registered April 9, 2021, https://clinicaltrials.gov/ct2/show/NCT04839978