Community Trial in the Cherokee Nation
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
919 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal