Clinical trial NCT04839978: Community Trial in the Cherokee Nation
Official title: Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Abuse
Keywords: American Indian
Cherokee Nation
Community intervention
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-04-09
Enrollment: 919
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Days of Alcohol Use
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Number of Days of Heavy Alcohol Use
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Number of Days of Marijuana Use
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Number of Days of Opioid Misuse
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
Secondary outcomes:
measure: Social Support From Parent/Caregiver
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Social Support From Friend
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Social Support From Teacher
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Social Support From Other Adult
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Perceived Availability of Alcohol
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Perceived Availability of Marijuana
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Perceived Availability of Prescription Opioids
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Social Normative Beliefs About Alcohol Use
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Social Normative Beliefs About Marijuana
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Social Normative Beliefs About Prescription Opioids
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Self-Efficacy
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Normative Estimates of Peer Drug Use
timeFrame: Baseline (fall of 10th grade) up to spring of 12th grade
measure: Number of Days of Alcohol Use
timeFrame: 6 Months Post-Graduation
measure: Number of Days of Heavy Alcohol Use
timeFrame: 6 Months Post-Graduation
measure: Number of Days of Marijuana Use
timeFrame: 6 Months Post-Graduation
measure: Number of Days of Opioid Drug Misuse
timeFrame: 6 Months Post-Graduation
Other outcomes:
Locations:
city: Tahlequah
country: United States
facility: Cherokee Nation Reservation
state: Oklahoma
Study officials:
affiliation: Emory University
name: Kelli Komro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.