Community Trial in the Cherokee Nation

NCT04839978 | Completed Results

• 3 other identifiers: STUDY00000404UH3DA050234UG3DA050234
• Study Type: interventional
• Target: 919
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Abuse

Keywords

American Indian; Cherokee Nation; Community intervention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (16)

• Social Support From Parent/Caregiver

  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

  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

  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

  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

  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)

Study Arms (2)

Preventive Intervention

EXPERIMENTAL

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; Behavioral: Communities Mobilizing for Change and Action (CMCA)

Control Group

NO INTERVENTION

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.

Interventions

Communities Mobilizing for Change and Action (CMCA) BEHAVIORAL

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.

Preventive Intervention

Connect Program BEHAVIORAL

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.

Preventive Intervention

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Tenth grade students enrolled in the participating high schools

You may not qualify if:

• unable to understand written or verbal English
• 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
• Metropolitan and micropolitan cores (Rural-Urban Commuting Area codes of 1 and 4)
• Existence of a community drug prevention coalition

Sponsors & Collaborators

• Emory University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Cherokee Nation Reservation

Tahlequah, Oklahoma, 74464, United States

Location

Related Publications (3)

• 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.

  PMID: 40768695 DERIVED

• 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.

  PMID: 39312248 DERIVED

• 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.

  PMID: 35197100 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Kelli Komro, PhD
• Organization: Emory University

kkomro@emory.edu

404-727-8742

Study Officials

• Kelli Komro, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Sixteen to 20 high schools and surrounding towns within the 14 counties that partially or fully fall within the Cherokee Nation reservation in northeast Oklahoma will be randomly assigned to receive the preventive interventions offered by this study or usual school and community prevention. A total of 800 to 1200 students are expected to enroll from the randomized sites.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 9, 2021
• Study Start: September 29, 2021
• Primary Completion: May 17, 2024
• Study Completion: December 31, 2024
• Last Updated: March 5, 2026
• Results First Posted: April 30, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will available for sharing following publication of the study findings.
• 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.

Locations

US (1)