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Abstract: Navajo Nation children have the greatest prevalence of early childhood caries in the United States. This protocol describes an innovative combination of community-based participatory research and clinical trial methods to rigorously test a lay native Community Oral Health Specialists-delivered oral health intervention, with the goal of reducing the progression of disease and improving family knowledge and behaviors. Methods/Design: This cluster-randomized trial designed by researchers at the Center for Native Oral Health Research at the University of Colorado in conjunction with members of the Navajo Nation community compares outcomes between the manualized 2-year oral health fluoride varnish-oral health promotion intervention and usual care in the community (child–caregiver dyads from 26 Head Start classrooms in each study arm; total of 1016 dyads). Outcome assessment includes annual dental screening and an annual caregiver survey of knowledge, attitudes and behaviors; collection of cost data will support cost–benefit analyses. Discussion: The study protocol meets all standards required of randomized clinical trials. Aligned with principles of community-based participatory research, extended interaction between members of the Navajo community and researchers preceded study initiation, and collaboration between project staff and a wide variety of community members informed the study design and implementation. We believe that the benefits of adding CBPR methods to those of randomized clinical studies outweigh the barriers and constraints, especially in studies of health disparities and in challenging settings. When done well, this innovative mix of methods will increase the likelihood of valid results that communities can use. [Copyright &y& Elsevier]

Purpose: To validate oral health knowledge and behavior measures from the Basic Research Factors Questionnaire, developed to capture specific themes contributing to children's oral health outcomes and the influence of caregivers.Methods: Data were collected as part of a randomized clinical trial (n equals 992) aimed at reducing dental caries in young children. Participants were American Indian/Alaska Native caregivers with a three- to five-year-old child enrolled in a Navajo Nation Head Start Center. Caregivers completed the questionnaire at enrollment with concomitant evaluation of children for decayed, missing, and filled tooth surfaces (dmfs). Oral health knowledge and behavior outcomes were compared with convergent measures (participant sociodemographic characteristics, oral health attitudes, and indicators of oral health status).Results: Caregiver oral health knowledge was significantly associated with education, income, oral health behavior, and all but one of the oral health attitude measures. Behavior was significantly associated with several measures of oral health attitudes and all but one measure of oral health status. As the behavior score improved, dmfs scores declined, child/caregiver overall oral health status improved, and pediatric oral health quality of life improved.Conclusions: Questionnaire measures were valid for predicting specific caregiver factors potentially contributing to children's oral health status. [ABSTRACT FROM AUTHOR]