Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558955
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Technology-enabled Anticipatory Guidance and Peer Support in Empowering Parents to Prevent Early Childhood Caries A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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 childs 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
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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None