Data category	Information
Primary registry and trial identifying number	Trial registration was completed through the U.S. National Library of Medicine ClinicalTrials.gov website (Identifier: NCT04845594)
Date of registration in primary registry	4/13/2021
Secondary identifying numbers	Not Applicable
Source(s) of monetary or material support	National Institute of Dental & Craniofacial Research of the National Institutes of Health (U01DE026739)
Primary sponsor	National Institute of Dental & Craniofacial Research of the National Institutes of Health (U01DE026739)
Secondary sponsor(s)	Not Applicable
Contact for public queries	CLL, PhD, MS, RD, CDN
	Columbia University College of Dental Medicine
Contact for scientific queries	CLL, PhD, MS, RD, CDN
	Columbia University College of Dental Medicine
Public title	Family-centered Behavioral Intervention to Reduce Early Childhood Caries: The MySmileBuddy Program efficacy trial
Scientific title	Randomized Efficacy Trial of MySmileBuddy, a Family Centered Behavioral Intervention to Reduce Early Childhood Caries
Countries of recruitment	United States
Health condition(s) or problem(s) studied	Early childhood dental caries
Intervention(s)	Intervention: Tooth brushing observation at T1 and during home visit with feedback and instruction immediately following observations; two administrations of the MSB technology (i.e., iPad app) by CHWs at the CCPH site (~ 30 min, face-to-face contact at T1 and T2, with T2 administered for data collection purposes only); six months of automated text messages (4 rounds of messages with approximately 50 messages each regarding key intervention topics: Brush twice a day; Brush your child’s teeth; Use fluoride toothpaste; Brush for at least one minute; Don’t buy snacks and drinks that cause cavities; Make water your go-to drink; Make eating time, time to eat; Sit to eat, don’t snack all day); one in-person, in-home visit and two telephone/text message follow-ups by CHWs; up to 4 additional supportive CHW contacts, in-person or by phone/text message are allowed, as needed, to address urgent social issues and will be recorded to discern potential impact on study outcomes
	Control: Mimic standard of care, providing paper-based educational handout plus toothbrushes and fluoridated toothpaste for the child at T1
Key inclusion and exclusion criteria	Ages eligible for study: well-children 24–71 months of age with a minimum of 12 teeth and apparent early childhood caries (ECC) or Severe ECC (S-ECC) as defined for research purposes; parents/caregivers ≥ 18 years of age with text-capable phone planning to reside in the New York area for next 12 months
	Exclusion criteria: Children with a disqualifying medical condition (that would limit oral dietary intake, at-home oral hygiene practices, or receipt of oral examinations)
Study type	Single-blind (clinical outcomes assessor) randomized controlled trial with randomization stratified by age (24 – 48 and 49 – 71 months) and recruitment site, with approximately equal numbers in each Group using a biased-coin design facilitated by computerized randomization software
Date of first enrolment	Pending
Target sample size	858 parent/child dyads
Recruitment status	Pending
Primary outcome(s)	Change in number of decayed, missing, or filled teeth (∆dmft > 0) or surfaces (∆dfs > 0)) measured 12-months post-randomization
Key secondary outcomes	Change in twice daily therapeutic toothbrushing (twice daily with appropriate amount of fluoridated toothpaste, by parents, for at least 1 min) and consumption of a low cariogenic diet (based on recommended frequency, duration, content, and timing of cariogenic foods and drink consumption)