About this item:

28 Views | 18 Downloads

Author Notes:

Kelli A. Komro, Email: kkomro@emory.edu

KAK, TKK, JRS, MDL, HLFC, and ACW developed the overarching scientific aims and design of the project. KAK, TKK, JRS, MDL, BJL, CMB, ALW, HLFC, and ACW participated in the development and operationalization of the study methods and worked with KAK to obtain institutional review board approval. KAK, TKK, JRS, and BJL are supporting study recruitment. TKK, BJL, CMB, and ALW are supporting data collection. KAK, JRS, BJL, KA, ANL, CMB, DWP, LJM, HLFC, and ACW developed study implementation strategies. All authors contributed to the development, drafting, or review of the manuscript and adhered to the authorship guidelines of Trials. All authors approved the final manuscript and agreed to publication. No professional writers have been involved.

All authors declare that they have no competing interests.

Research Funding:

Research reported in this publication was supported by the National Institute On Drug Abuse of the National Institutes of Health through the NIH HEAL Initiative under Award Numbers UG3DA050234 and UH3DA050234 to Emory University [principal investigator (PI) Komro; sub-award to Cherokee Nation, PIs Kominsky, Skinner]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or its NIH HEAL Initiative. The award was issued as a Cooperative Agreement in which NIH scientific involvement is anticipated in the performance of the trial. Dr. Kathy Etz is the NIH Project Scientist for this Cooperative Agreement and will participate as a co-investigator. The funder played no role in the study design and writing of the protocol, or the decision to submit the protocol for publication.


  • Science & Technology
  • Life Sciences & Biomedicine
  • Medicine, Research & Experimental
  • Research & Experimental Medicine
  • Opioids
  • Marijuana
  • Alcohol
  • Primary prevention
  • Multi-level intervention
  • Youth
  • American Indian
  • Rural

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

Show all authors Show less authors


Journal Title:



Volume 23, Number 1


, Pages 175-175

Type of Work:

Article | Final Publisher PDF


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 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. 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 (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”). 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 on April 9, 2021. Version 4, January 26, 2022.

Copyright information:

© The Author(s) 2022

This is an Open Access work distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/rdf).
Export to EndNote