Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries

Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries: A Randomized Controlled Trial

Early Childhood Caries (ECC) is a significant clinical and public health challenge that the world and the Singapore population are facing. This study seeks to test the effectiveness of technology-enabled anticipatory guidance and peer support in empowering parents to establish proper childcare practices and prevent ECC.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries in Children; Dental Caries; Diet Habit
• Intervention / Treatment: Behavioral: Technology-enabled anticipatory guidance and peer support; Behavioral: Conventional health education

Detailed Description

The study design is a two-arm, parallel group, assessor-blinded, randomised controlled trial. The hypothesis is that technology-enabled anticipatory guidance and peer support is more effective than conventional oral health education in enhancing parental efficacy, establishing proper childcare practices (dietary, feeding and toothbrushing), and preventing ECC. Up to 600 mother-child dyads will be recruited and randomly assigned to receive conventional oral health education (control), and technology-enabled anticipatory guidance and peer support (intervention), respectively. For the intervention arm, anticipatory guidance and peer support will be delivered through 4 unique online sessions for mothers, when each child turns 3, 6, 12, and 18 months, to match the developmental milestones and parental needs for childcare support. Outcomes will be assessed through a questionnaire and food diary (at 12, 24 and 36 months of child's age) and a dental examination for the child (at 24 and 36 months of age).

The effectiveness of the intervention will be evaluated using psychological outcomes (parental efficacy), behavioral outcomes (dietary, feeding and oral hygiene practices), and clinical outcomes (oral hygiene and ECC), and quality of life outcomes. Process evaluation and cost-effectiveness analysis will be included. Data will be analyzed on an intention-to-treat basis, including with the last observation carried forward method. Descriptive statistics on socio-demographic backgrounds, parental efficacy, childcare practices, child's oral health status, and oral health related quality of life will be reported. Chi-square test and two-sample t-test, or their non-parametric equivalents, will be used as appropriate to compare proportions and means between the control and intervention groups. Effect sizes and number needed to be treated will be presented to provide an estimate of the number of parents needed to be intervened in order to avoid one child with new dental caries. Multivariable analyses will be performed to evaluate the effectiveness of the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoli Gao, PhD; Phone Number: (65) 6772 4990; Email: dengx@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National University Hospital
    • Contact: Zubair Amin; Phone Number: 67725075; Email: paeza@nus.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Mother is currently expecting or has an infant below 3 months of age
• Biological mother of the child
• Mother with internet access and a mobile device
• Mother can communicate in English
• Mother aged 21 years and above

Exclusion Criteria:

• Child with disqualifying medical condition (e.g., tube feeding, severe neuromuscular disability) that would limit oral dietary intake, at-home oral hygiene practices, or receipt of dental examinations
• Child with serious congenital syndrome that is expected to adversely affect the development of primary teeth
• Family plans to emigrate within 3 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Technology-enabled anticipatory guidance and peer support; Participants (mothers) will join online parent empowerment sessions for about 4 times (around 3, 6, 12, and 18 months of child's age, around 45 - 60 minutes each), and receive additional information and push notifications via a mobile phone app.	Behavioral: Technology-enabled anticipatory guidance and peer support; The intervention includes 4 online sessions led by an oral health therapist (OHT) or dentist, as well as push notifications and information delivered to participants via a mobile/web app.
Active Comparator: Conventional oral health education; Participants (mothers) will receive child oral health information for about 4 times (around 3, 6, 12, and 18 months of child's age).	Behavioral: Conventional health education; Participants on this arm will receive conventional child oral health education materials at 4 time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of early childhood caries	Number of new surfaces with coronal caries	24 and 36 months of age for children

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toothbrushing behaviours	Using a questionnaire, toothbrushing behaviours will be categorised as: Favourable (frequency of brushing >=2times/day); Unfavourable (frequency of brushing <2times/day)	12, 24 and 36 months of age for children
Dietary and feeding practices (favourable/unfavourable)	Self-reported frequency of snack, sweet/dessert and sugary drink intake	12, 24 and 36 months of age for children
Dental Utilisation	Self-reported frequency of dental visits	12, 24 and 36 months of age for children
Dental Costs	Sum of direct costs from dental treatment and indirect costs due to time taken off work by parents to attend dental visits, and loss of productivity. Costs will be captured in Singapore dollars (SGD).	12, 24 and 36 months of age for children
Parental efficacy in managing oral health of child	Measured using the self-efficacy scale for maternal oral care (SESMO). Response options ("Yes" and "No"). A score of 1 is given for an answer with higher self-efficacy and 0 for lower self-efficacy. Minimum score is 0 and maximum score is 16 for the 16 questions. Higher scores indicate better outcomes.	12, 24 and 36 months of age for children
Plaque score	Plaque score based on the index recommended by Ramjford and modified for primary dentition. The plaque score is coded as following: 2 = visible plaque without use of probe, 1 = no visible plaque but a probe skimmed over the tooth surface reveals plaque, 0 = no plaque. Scoring is done at three sites (interproximal, buccal and palatal/lingual) on the index teeth (#54, #61, #64, #74, #81, #84).	24 and 36 months of age for children
Breastfeeding rate	Duration of breastfeeding (in months)	12 and 24 months of age for children

Collaborators and Investigators

• Sponsor: National University of Singapore
• Investigators: Principal Investigator: Xiaoli Gao, PhD, National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Oral Health; Dental Caries; Technology; Peer Support; Anticipatory Guidance
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: DSRB 2024/00244; PHRGOC23jul-0011 (Other Grant/Funding Number: National Medical Research Council, Singapore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No