Motivational interviewing with American Indian mothers to prevent early childhood caries: Study design and methodology of a randomized control trial

Background: This randomized control trial assesses the effectiveness of motivational interviewing (MI) to encourage behavior change in new mothers relating to caries prevention when caring for their newborn American Indian (AI) infants and young AI children.Methods/Design: The study is a randomized control trial. We hypothesize that when motivational interviewing is added to enhanced community oral health education services, the new mothers will achieve greater reduction of caries experience in their AI children compared to those who are receiving enhanced community services (ECS) alone. Six hundred mothers or caregivers of AI newborns will be enrolled into the study and randomized to one of the two intervention groups over a two-year period. The children will be followed until the child's third birthday. A cost analysis of the study is being conducted in tandem with the enhanced community services, motivational interviewing behavioral interventions, and the dental screenings for the length of the study.Discussion: The trial is now in the implementation phase and a number of threats to successful completion, such as recruitment and retention challenges in a vast, rural geographic area, have been addressed. The protocol provides a unique model for oral health interventions using principles of community-based participatory research and is currently on schedule to meet study objectives. If the study is successful, motivational interviewing intervention can be applied in AI communities to reduce ECC disparities in this disadvantaged population, with study of further applicability in other populations and settings.Trial registration: ClinicalTrials.gov, NCT01116726.