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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
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...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8864592/ https://www.ncbi.nlm.nih.gov/pubmed/35197100 http://dx.doi.org/10.1186/s13063-022-06096-0 |
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author | 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. |
author_facet | 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. |
author_sort | Komro, Kelli A. |
collection | PubMed |
description | 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06096-0. |
format | Online Article Text |
id | pubmed-8864592 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-88645922022-02-23 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 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. Trials Study Protocol 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06096-0. BioMed Central 2022-02-23 /pmc/articles/PMC8864592/ /pubmed/35197100 http://dx.doi.org/10.1186/s13063-022-06096-0 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol 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. 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8864592/ https://www.ncbi.nlm.nih.gov/pubmed/35197100 http://dx.doi.org/10.1186/s13063-022-06096-0 |
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