Prevention trial in the Cherokee Nation: design of a randomized community trial.

Despite advances in prevention science and practice in recent decades, the U.S. continues to struggle with significant alcohol-related risks and consequences among youth, especially among vulnerable rural and Native American youth. The Prevention Trial in the Cherokee Nation is a partnership between prevention scientists and Cherokee Nation Behavioral Health to create, implement, and evaluate a new, integrated community-level intervention designed to prevent underage drinking and associated negative consequences among Native American and other youth living in rural high-risk underserved communities. The intervention builds directly on results of multiple previous trials of two conceptually distinct approaches. The first is an updated version of CMCA, an established community environmental change intervention, and the second is CONNECT, our newly developed population-wide intervention based on screening, brief intervention, and referral to treatment (SBIRT) research. CMCA direct-action community organizing is used to engage local citizens to address community norms and practices related to alcohol use and commercial and social access to alcohol among adolescents. The new CONNECT intervention expands traditional SBIRT to be implemented universally within schools. Six key research design elements optimize causal inference and experimental evaluation of intervention effects, including a controlled interrupted time-series design, purposive selection of towns, random assignment to study condition, nested cohorts as well as repeated cross-sectional observations, a factorial design crossing two conceptually distinct interventions, and multiple comparison groups. The purpose of this paper is to describe the strong partnership between prevention scientists and behavioral health leaders within the Cherokee Nation, and the intervention and research design of this new community trial.