Batliner 2014.

Trial name or title	Promoting behavioural change for oral health in American Indian mothers and children
Methods	RCT: NCT01116726
Participants	Recruitment target: 1134 participants Inclusion criteria: American Indian, as defined by the tribe; mothers or caregivers of newborn children; at least 15 to 44 years of age (minors who are 15 to 17 years of age must get consent from a parent or legal guardian according to Tribal, State and IHS rules and regulations); able to read, understand and sign a consent/assent form; be willing and able to follow study procedures and instructions. Trialists noted that, although expected to be rare, if the father is a sole caregiver, he and his child will be eligible for the study. Exclusion criteria: none declared Setting: United States
Interventions	Intervention group: motivational interviewing and enhanced community services. Motivational interviewing involves home visits, concentrating on the mitigation of behavioural risk factors for early childhood caries. These take place shortly after childbirth and at months 6. 12, and 18. Enhanced community services involve the development of culturally appropriate messages related to the mitigation of behavioural risk factors for early childhood caries through public service announcement and brochures. Control group: enhanced community services, as per the intervention group
Outcomes	Primary outcome: decayed, missing and filled tooth surfaces (dmfs), assessed over 3 years Other outcomes: dental knowledge, attitudes, and behaviours of mothers, assessed over 3 years; dental caries patterns of children, assessed over 3 years; costs of dental care, assessed up to 3 years after randomisation; other decayed, missing and filled tooth surfaces measures, assessed over 3 years
Starting date	August 2011
Contact information	Terry Batliner, email: not reported
Notes	Last updated post on Clinical Trials.gov site: 18 January 2018