Community Trial in the Cherokee Nation

Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents

The target population is students attending high schools in small rural towns in the 14 counties that partially or fully fall within the Cherokee Nation reservation. Following recruitment of 20 school-based clusters, clusters are allocated to either the intervention condition or delayed-intervention control condition using constrained randomization. Constrained randomization helps to ensure balanced cluster sizes as well as similar levels of risk between the intervention and control at baseline. Study participants include all 10th grade students enrolled in the participating study high schools and students will be followed into the first year after their expected graduation.

Study Overview

• Status: Completed
• Conditions: Opioid Abuse
• Intervention / Treatment: Behavioral: Connect Program; Behavioral: Communities Mobilizing for Change and Action (CMCA)

Detailed Description

The national public health opioid crisis has disproportionately burdened rural White populations, and disproportionately burdened American Indian populations. Therefore, the Cherokee Nation (CN) and Emory University public health scientists have designed an opioid prevention trial to be conducted in at-risk rural communities in the CN (in northeast Oklahoma) with primarily White and American Indian adolescents and young adults. The goal of this study 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. The researchers propose a cluster randomized trial building directly on the success of their most recent previous trial, which demonstrated that the intervention effectively reduced alcohol and other drug use among American Indian and other youth living within the CN. Two distinct intervention approaches-community organizing as implemented in the established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral as implemented in the established Connect intervention protocol -will be expanded and integrated to further enhance effects in preventing and reducing opioid misuse. The CMCA and Connect interventions were originally designed to target adolescent alcohol use but nevertheless showed significant beneficial effects on use of other drugs, including prescription drug misuse. The proposed study will: (1) further improve the design of the interventions with increased focus on opioids, (2) test the expanded, integrated versions in a cluster randomized trial, and (3) design and test new systems for sustained implementation within existing structures of the Cherokee Nation. Building upon the extant prevention science evidence, this study will respond to a gap in evidence concerning opioid misuse prevention among at-risk adolescents transitioning to young adulthood among American Indian and other rural youth.

• Study Type: Interventional
• Enrollment (Actual): 919
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tahlequah, Oklahoma, United States, 74464
      • Cherokee Nation Reservation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Tenth grade students enrolled in the participating high schools

Exclusion Criteria:

• unable to understand written or verbal English

Inclusion criteria for high schools:

• Counties that partially or fully fall within the Cherokee Nation reservation
• Town population of 3,000 or less
• Class size between 30 to 100 students

Exclusion criteria for high schools:

• Metropolitan and micropolitan cores (Rural-Urban Commuting Area codes of 1 and 4)
• Existence of a community drug prevention coalition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preventive Intervention; Students in schools assigned to the preventive intervention study condition will take part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.	Behavioral: Connect Program; The Connect program includes school-based screening, brief intervention and referral, and will be treated as part of the participating schools' prevention programs. A computer-based screening and brief intervention will be supported by Cherokee Nation Behavioral Health (CNBH) supervised Connect coaches universally, to reduce potential stigma associated with speaking to a Connect coach and to reinforce drug free norms among all students. Follow-up of moderate to high-risk youth will be conducted by a Connect Coach through Zoom, other electronic communication, or in-person visits, with referral to Cherokee Nation or community services if deemed necessary.; Behavioral: Communities Mobilizing for Change and Action (CMCA); The community-level intervention Communities Mobilizing for Change and Action (CMCA) will involve educating and organizing of adult volunteers and consent will be assumed by their participation. Trainings and tools will be provided, including Family Action Kits, to support local families, community organizations and citizens, including information on national and local opioid and other drug use, evidence-based policies, programs and practices, and how to motivate and create family and local action for drug prevention.
No Intervention: Control Group; Students in schools assigned to the control group will not receive the Connect and CMCA interventions. Schools in the control group will receive usual school and community prevention and will be offered the trial's programs after the end of this three-year study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days of Alcohol Use	The number of days of alcohol use in the past 30 days is compared between study arms.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Number of Days of Heavy Alcohol Use	The number of days of heavy alcohol use in the past 30 days is compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Number of Days of Marijuana Use	The number of days of marijuana use in the past 30 days is compared between study arms.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Number of Days of Opioid Misuse	The number of days of opioid drug misuse use in the past 30 days is compared between study arms.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Support From Parent/Caregiver	Social support from parents/caregivers is assessed with 6 items which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Support From Friend	Social support from a friend is assessed with 6 items, which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Support From Teacher	Social support from a teacher is assessed with 6 items, which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Support From Other Adult	Social support from an adult, other than a parent/caregiver or teacher, is assessed with 6 items which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Perceived Availability of Alcohol	Ease or difficulty in accessing alcohol is assessed with 4 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Perceived Availability of Marijuana	Ease or difficulty in accessing marijuana is assessed with 5 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Perceived Availability of Prescription Opioids	Ease or difficulty in accessing prescription opioids is assessed with 5 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Normative Beliefs About Alcohol Use	Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people drinking alcohol. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Normative Beliefs About Marijuana	Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people using marijuana. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Normative Beliefs About Prescription Opioids	Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people missing prescription opioids. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Self-Efficacy	Self-efficacy is assessed with 3 items asking how easy or hard it would be for participants to ask for help or refuse alcohol or drugs. Responses given on a 4-point scale, where 1 = very easy and 4 = very hard. The total score is expressed as the mean across items and ranges from 1 to 4, with lower scores indicating increased self-efficacy.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Normative Estimates of Peer Drug Use	Normative estimates of peer drug use (alcohol, marijuana, prescription opioid misuse) are assessed with 3 items asking about how many of their peers in school used drugs in the past year. Possible responses are 1 = none or almost none, 2 = less than half, 3 = about half, 4 = more than half, and 5 = almost all or all. The total score is expressed as the mean across items and ranges from 1 to 5, with higher scores indicating higher normative estimates of peer drug use.	Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Proportion of Participants With Alcohol Use 6 Months Post-Graduation	Model predicted proportion of participants with alcohol use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.	6 Months Post-Graduation
Proportion of Participants With Heavy Alcohol Use 6 Months Post-Graduation	Model predicted proportion of participants with heavy alcohol use in the past 30 days is compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.	6 Months Post-Graduation
Proportion of Participants With Marijuana Use 6 Months Post-Graduation	Model predicted proportion of participants with marijuana use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.	6 Months Post-Graduation
Number of Participants With Opioid Drug Misuse 6 Months Post-Graduation	The number of participants reporting prescription opioid misuse in the past 30 days at the survey administered 6-month post-graduation.	6 Months Post-Graduation

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Kelli Komro, PhD, Emory University

Publications and helpful links

General Publications

• 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. 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. Trials. 2022 Feb 23;23(1):175. doi: 10.1186/s13063-022-06096-0.
• Komro KA, Livingston MD, Skinner JR, Livingston BJ, Kominsky TK, Jagtiani A, Barry CM, Wagenaar AC, Cooper HLF, Harmon M, Ivanich E, LaBounty H, Gassaway AN, Talavera-Brown SL. Primary Prevention of Drug Overdoses in Rural Low-Resource and Tribal Communities: A Cluster Randomized Trial. Am J Public Health. 2025 Sep;115(9):1508-1517. doi: 10.2105/AJPH.2025.308205.
• Jagtiani A, Livingston MD, Barry CM, Talavera-Brown S, LaBounty H, Skinner JR, Livingston BJ, Lincoln AN, Komro KA. Tribal Identity, Pain Interference, and Substance Use Among American Indian and Alaska Native Adolescents. JAMA Pediatr. 2024 Nov 1;178(11):1192-1198. doi: 10.1001/jamapediatrics.2024.3284.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): May 17, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: American Indian; Community intervention; Cherokee Nation
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: STUDY00000404; UH3DA050234 (U.S. NIH Grant/Contract); UG3DA050234 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data will be available for sharing, provided all data requests are reviewed and approved by the Cherokee Nation Institutional Review Board (IRB). Data and associated documentation sharing requires a negotiated data-sharing agreement that provides for: 1) review and approval of the data request and study protocol by the Cherokee Nation IRB, 2) a commitment to using the data only for research purposes, 3) restrictions against attempting to identify study participants, 4) a commitment to securing the data using secure computer technology, 5) a commitment to destroying data after the specific requested analyses are completed, 6) agreement to submit all presentations and manuscripts to the appropriate tribal authorities for review and approval prior to public dissemination and publication, 7) reporting responsibilities to the Cherokee Nation, 8) restrictions on redistribution of the data to third parties, and 9) proper acknowledgement of the source of the data.
• IPD Sharing Time Frame: Data will available for sharing following publication of the study findings.
• IPD Sharing Access Criteria: It is the responsibility of any external party requesting access to project data to request in writing to the project PI the specific data requested, and to apply to the Cherokee Nation IRB for such access according to procedures promulgated by the Cherokee Nation. Further, any such access is conditional on meeting all requirements specified by the Cherokee Nation IRB. Persons interested in using the data should contact the PI listed on manuscripts and publications as a means of facilitating access to the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No