Menu
Recruiting NCT06558955

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

No phase Interventional Dental Caries Dental Caries in Children Diet Habit

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Technology-enabled anticipatory guidance and peer support, Conventional health education.
Who it may be relevant to
Registry conditions: Dental Caries, Dental Caries in Children, Diet Habit. Basic parameters: from 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • Behavioral Conventional health education
    Participants on this arm will receive conventional child oral health education materials at 4 time points.

Primary outcome measures

  • Incidence of early childhood caries [Time frame: 24 and 36 months of age for children]
Secondary outcome measures (7)
  • Toothbrushing behaviours [Time frame: 12, 24 and 36 months of age for children]
  • Dietary and feeding practices (favourable/unfavourable) [Time frame: 12, 24 and 36 months of age for children]
  • Dental Utilisation [Time frame: 12, 24 and 36 months of age for children]
  • Dental Costs [Time frame: 12, 24 and 36 months of age for children]
  • Parental efficacy in managing oral health of child [Time frame: 12, 24 and 36 months of age for children]
  • Plaque score [Time frame: 24 and 36 months of age for children]
  • Breastfeeding rate [Time frame: 12 and 24 months of age for children]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Singapore · 1 center
  • National University Hospital — Singapore

Publications

  • Gao X, Tan SHX, Hong CHL, Chong MFF, Wong ML, Ng YPM, Koh GCH, Foong PS, Pramanick A, Eu OC, Gallagher JE, Amin Z. Technology-enabled anticipatory guidance and peer support in empowering parents to prevent early childhood caries: a randomized controlled trial. BMC Oral Health. 2024 Dec 4;24(1):1470. doi: 10.1186/s12903-024-05204-7. PMID 39633367

Identifiers

NCT: NCT06558955 · DSRB 2024/00244 · PHRGOC23jul-0011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗