Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 919
- Locations
- 1
- Primary Endpoint
- Number of Days of Alcohol Use
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Connect Program (Behavioral)
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.
Intervention: Communities Mobilizing for Change and Action (CMCA) (Behavioral)
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.
Outcomes
Primary Outcomes
Number of Days of Alcohol Use
Time Frame: 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)
The number of days of alcohol use in the past 30 days is compared between study arms.
Number of Days of Heavy Alcohol Use
Time Frame: 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)
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.
Number of Days of Marijuana Use
Time Frame: 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)
The number of days of marijuana use in the past 30 days is compared between study arms.
Number of Days of Opioid Misuse
Time Frame: 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)
The number of days of opioid drug misuse use in the past 30 days is compared between study arms.
Secondary Outcomes
- 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))
- Perceived Availability of Marijuana(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(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(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(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(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(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(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(6 Months Post-Graduation)
- Proportion of Participants With Heavy Alcohol Use 6 Months Post-Graduation(6 Months Post-Graduation)
- Proportion of Participants With Marijuana Use 6 Months Post-Graduation(6 Months Post-Graduation)
- Number of Participants With Opioid Drug Misuse 6 Months Post-Graduation(6 Months Post-Graduation)
Investigators
Kelli Komro
Professor
Emory University