Community Trial in the Cherokee Nation

Study Overview
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Brief Summary
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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 all10th grade students enrolled in the participating study high schools and students will be followed into the first year after their expected graduation.

Detailed Description
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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.

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

Conditions
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Opioid Abuse

Intervention / Treatment
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* Behavioral: Connect Program
* Behavioral: Communities Mobilizing for Change and Action (CMCA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 intervention right away or later. A total of 800 to 1200 students are expected to enroll from the randomized sites.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preventive Intervention<br>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<br>* 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 drugfree 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.<br>Behavioral: Communities Mobilizing for Change and Action (CMCA)<br>* 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. We will provide trainings and tools, 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.<br>|
| No Intervention: Delayed Intervention Control Group<br>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 be offered the trial's programs after this three-year study ends. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Days of Alcohol Use | The number of days of alcohol use in the past 30 days will be compared between study arms. | Baseline (fall of 10th grade) up to spring of 12th grade | 
| Change in Number of Days of Heavy Alcohol Use | The number of days of heavy alcohol use in the past 30 days will be 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. | Baseline (fall of 10th grade) up to spring of 12th grade | 
| Change in Number of Days of Marijuana Use | The number of days of marijuana use in the past 30 days will be compared between study arms. | Baseline (fall of 10th grade) up to spring of 12th grade | 
| Change in Number of Days of Opioid Drug Misuse | The number of days of prescription opioid misuse in the past 30 days will be compared between study arms. | Baseline (fall of 10th grade) up to spring of 12th grade | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Social Support | Social support from parents/caregivers, friends, teachers, and community members is assessed with 24 items which are responded to on a 4-point scale where 0 = never and 3 = often. Total scores range from 0 to 72 and higher scores indicate greater support. | Baseline (fall of 10th grade) up to spring of 12th grade | 
| Change in Perceived Availability of Drugs | Ease or difficulty in accessing alcohol, marijuana, and prescription opioids is assessed with 12 items using a 4-point scale where 0 = very difficult to get and 3 = very easy to get. Total scores range from 0 to 36, with higher scores indicating greater ease of availability. | Baseline (fall of 10th grade) up to spring of 12th grade | 
| Change in Social Normative Beliefs about Drug Use | Participants will be asked 12 items to assess if they think various social groups disapprove of young people drinking alcohol, using marijuana, and prescription opioid misuse (parents, community adults, peers, self). Responses are given as 0 = don't disapprove, 1 = disapprove, and 2 = strongly disapprove. Total scores range from 0 to 24 with higher scores indicating stronger disapproval. | Baseline (fall of 10th grade) up to spring of 12th grade | 
| Change in Self-Efficacy | Self-efficacy is assessed with 4 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 0 = very easy and 3 = very hard. Total scores range from 0 to 12 and lower scores indicate increased self-efficacy. | Baseline (fall of 10th grade) up to spring of 12th grade | 
| Change in 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 0 = none or almost none, 1 = less than half, 2 = about half, 3 = more than half, and 4 = almost all or all. Total scores range from 0 to 12 and higher scores indicate higher normative estimates of peer drug use. | Baseline (fall of 10th grade) up to spring of 12th grade | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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American Indian, Cherokee Nation, Community intervention