Preventing caries in preschoolers: successful initiation of an innovative community-based clinical trial in Navajo Nation Head Start.
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
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.


CONCLUSIONS
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.
Department of Craniofacial Biology, School of Dental Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO 80045, United States. Electronic address: david.quissell@ucdenver.edu.
David O
DO
Quissell
Department of Community and Behavioral Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 East 17th Place B119, Aurora, CO 80045, United States. Electronic address: Lucinda.bryant@ucdenver.edu.
Lucinda L
LL
Bryant
Children's Outcomes Research Program, University of Colorado Anschutz Medical Campus, 13199 E. Montview Blvd., Suite 300 F443, Aurora, CO 80045, United States. Electronic address: Patricia.braun@ucdenver.edu.
Patricia A
PA
Braun
Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Nighthorse Campbell Native Health Building, Mail Stop F800, 13055 E. 17th Avenue, Aurora, CO 80045, United States. Electronic address: Diana.cudeii@ucdenver.edu.
Diana
D
Cudeii
Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Nighthorse Campbell Native Health Building, Mail Stop F800, 13055 E. 17th Avenue, Aurora, CO 80045, United States. Electronic address: Nikolas.johs@ucdenver.edu.
Nikolas
N
Johs
Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Nighthorse Campbell Native Health Building, Mail Stop F800, 13055 E. 17th Avenue, Aurora, CO 80045, United States. Electronic address: Vonglsmith@gmail.com.
Vongphone L
VL
Smith
Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Nighthorse Campbell Native Health Building, Mail Stop F800, 13055 E. 17th Avenue, Aurora, CO 80045, United States. Electronic address: Carmen.george@ucdenver.edu.
Carmen
C
George
Children's Outcomes Research Program, University of Colorado Anschutz Medical Campus, 13199 E. Montview Blvd., Suite 300 F443, Aurora, CO 80045, United States; Department of Biostatistics & Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17th Avenue, Aurora, CO 80045, United States. Electronic address: William.henderson@ucdenver.edu.
William G
WG
Henderson
Centers for American Indian and Alaska Native Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Nighthorse Campbell Native Health Building, Mail Stop F800, 13055 E. 17th Avenue, Aurora, CO 80045, United States. Electronic address: Judith.albino@ucdenver.edu.
Judith
J
Albino
D017028:Caregivers; D002327:Cariostatic Agents / Q000008:administration & dosage; D002675:Child, Preschool; D055812:Community-Based Participatory Research; D003362:Cost-Benefit Analysis; D003731:Dental Caries / Q000517:prevention & control*; D005260:Female; D005460:Fluorides, Topical / Q000008:administration & dosage; D007722:Health Knowledge, Attitudes, Practice; D006293:Health Promotion / Q000458:organization & administration*; D006801:Humans; D007198:Indians, North American; D008297:Male; D009909:Oral Health; D011203:Poverty; D012107:Research Design; D014481:United States
D002327:Cariostatic Agents; D005460:Fluorides, Topical
Clinical trial; Community-based research; Disparities; Indigenous populations; Native American; Oral health