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NCT Number: NCT06558955

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

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.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore

Location status: Recruiting

Location contact

Zubair Amin

CONTACT

[email protected]

67725075

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technology-enabled anticipatory guidance and peer support

Behavioral

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.

Conventional health education

Behavioral

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

Primary outcomes

  1. Incidence of early childhood caries

    Time frame: 24 and 36 months of age for children

    Number of new surfaces with coronal caries

Secondary outcomes

  1. Toothbrushing behaviours

    Time frame: 12, 24 and 36 months of age for children

    Using a questionnaire, toothbrushing behaviours will be categorised as:

    • Favourable (frequency of brushing >=2times/day)
    • Unfavourable (frequency of brushing <2times/day)
  2. Dietary and feeding practices (favourable/unfavourable)

    Time frame: 12, 24 and 36 months of age for children

    Self-reported frequency of snack, sweet/dessert and sugary drink intake

  3. Dental Utilisation

    Time frame: 12, 24 and 36 months of age for children

    Self-reported frequency of dental visits

  4. Dental Costs

    Time frame: 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).

  5. Parental efficacy in managing oral health of child

    Time frame: 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.

  6. Plaque score

    Time frame: 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).

  7. Breastfeeding rate

    Time frame: 12 and 24 months of age for children

    Duration of breastfeeding (in months)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoli Gao, PhD

CONTACT

[email protected]

(65) 6772 4990

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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