Clinical trial NCT06558955: Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries
Official title: Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Caries
Dental Caries in Children
Diet Habit
Keywords: Anticipatory Guidance
Peer Support
Oral Health
Technology
Dental Caries
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of early childhood caries
timeFrame: 24 and 36 months of age for children
Secondary outcomes:
measure: Toothbrushing behaviours
timeFrame: 12, 24 and 36 months of age for children
measure: Dietary and feeding practices (favourable/unfavourable)
timeFrame: 12, 24 and 36 months of age for children
measure: Dental Utilisation
timeFrame: 12, 24 and 36 months of age for children
measure: Dental Costs
timeFrame: 12, 24 and 36 months of age for children
measure: Parental efficacy in managing oral health of child
timeFrame: 12, 24 and 36 months of age for children
measure: Plaque score
timeFrame: 24 and 36 months of age for children
measure: Breastfeeding rate
timeFrame: 12 and 24 months of age for children
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University of Singapore
name: Xiaoli Gao, PhD
role: PRINCIPAL_INVESTIGATOR
References: