Challenges in designing intervention studies to reduce oral health disparities in American Indian/Alaska Native (AI/AN) populations

Oral disease is much more prevalent in AI/AN populations compared to other groups in the U.S. The Center for Native Oral Health Research (CNOHR)(NIDCR U54-DE019259)in the Centers for American Indian/Alaska Native Health (CAIANH) at the University of Colorado was established to design and conduct intervention studies to reduce Early Childhood Caries (ECC) and other oral health disparities in AI/AN populations. CNOHR is currently conducting two large-scale clinical trials of different interventions to reduce ECC in two different AI/AN populations. One study in a Northern Plains AI/AN population involves using Motivational Interviewing to teach well-accepted oral health practices to assist new mothers in preventing ECC in their newborns. The other study, proposed for a Southwestern AI/AN population, involves training community oral health specialists to provide fluoride varnishes and oral health education in Head Start Centers. In the first study, the target of the intervention and unit of randomization is the mother/child. In the second study, they are the Head Start Center. The design of intervention studies in AI/AN populations presents special challenges in terms of settings in which the intervention is given and the unit of randomization, selection of a control group, acceptance of randomization and control groups by the AI/AN communities, application of the intervention and data capture methods in remote areas, measuring the effects of moderators/mediators, follow-up of study participants, and the processes of review and approval of the research. The special design challenges in conducting these studies will be addressed in this presentation.