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

Not Applicable

Recruiting

• Conditions: Dental Caries; Dental Caries in Children; Diet Habit
• Interventions: Behavioral: Technology-enabled anticipatory guidance and peer support; Behavioral: Conventional health education

• Registration Number: NCT06558955
• Lead Sponsor: National University of Singapore

Brief Summary

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.

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 Timeline

• Study Start: 2024-06-15
• Study First Submitted: 2024-07-15
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-15
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Primary Completion: 2027-12-31
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technology-enabled anticipatory guidance and peer support	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.
Conventional oral health education	Conventional 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).

Primary Outcome Measures

Name	Time	Method
Incidence of early childhood caries	24 and 36 months of age for children	Number of new surfaces with coronal caries

Secondary Outcome Measures

Name	Time	Method
Dental Utilisation	12, 24 and 36 months of age for children	Self-reported frequency of dental visits
Breastfeeding rate	12 and 24 months of age for children	Duration of breastfeeding (in months)
Parental efficacy in managing oral health of child	12, 24 and 36 months of age for children	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.
Plaque score	24 and 36 months of age for children	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).
Toothbrushing behaviours	12, 24 and 36 months of age for children	Using a questionnaire, toothbrushing behaviours will be categorised as: 1. Favourable (frequency of brushing \>=2times/day); 2. Unfavourable (frequency of brushing \<2times/day)
Dietary and feeding practices (favourable/unfavourable)	12, 24 and 36 months of age for children	Self-reported frequency of snack, sweet/dessert and sugary drink intake
Dental Costs	12, 24 and 36 months of age for children	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).

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore