Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT06855693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-25
First Post:
2025-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Involving Parents to Improve Tooth Brushing for Autistic Children.
Sponsor:
Sussex Community NHS Foundation Trust
Organization:
Study Overview
Official Title:
Oral Health Care Guidance to Enhance Parent Confidence and Ability to Improve Toothbrushing Performance for Autistic Children
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parents of autistic children have reported a lack of understanding by oral health care staff around delivery of oral health preventive habits for their children.
This study aims to investigate if oral healthcare training utilising the Mini Mouth Care Matters (MCM) programme designed for Special Education Settings (SES) enhances parent confidence in their ability to influence their child's oral health, increases toothbrushing episodes and reduces challenging toothbrushing behaviour of autistic children.
The participants of this study will be parents of children who have a confirmed professional diagnosis of Autistic Spectrum Disorder. Parents will be recruited via healthcare professionals who provide oral health promotion within SES. Special Education Settings will be randomised into one of two groups. Group one will receive 'delivering better oral health' advice. Group two will receive the MCM user intervention guide for oral healthcare.
A maximum of 30 parents will be recruited into each intervention arm. A maximum of 60 parents will be recruited to the study.
This study aims to investigate if oral healthcare training utilising the Mini Mouth Care Matters (MCM) programme designed for Special Education Settings (SES) enhances parent confidence in their ability to influence their child's oral health, increases toothbrushing episodes and reduces challenging toothbrushing behaviour of autistic children.
The participants of this study will be parents of children who have a confirmed professional diagnosis of Autistic Spectrum Disorder. Parents will be recruited via healthcare professionals who provide oral health promotion within SES. Special Education Settings will be randomised into one of two groups. Group one will receive 'delivering better oral health' advice. Group two will receive the MCM user intervention guide for oral healthcare.
A maximum of 30 parents will be recruited into each intervention arm. A maximum of 60 parents will be recruited to the study.
Detailed Description:
Description of the Intervention:
The first national dental health survey for special schools in England shows that:
* At ages 5 and 12, compared to previous surveys in mainstream education, the proportion of children in special education with substantial plaque visible is almost double.
* Children aged 5 in special schools were twice as likely to have had one or more teeth extracted.
The Office of the Chief Dental Officer Special Education Settings Team has developed resources which focus on prevention for better oral health for children with learning disabilities, autism or both. Resources include information and tips to help parents and carers with frequent concerns such as: Am I using the right toothpaste? Have I got the right toothbrush? Is the environment right? Am I doing it right? The resources are available on the HEE hub e- Learning for Healthcare (e-LfH) through the link Mini Mouth Care Matters (Mini MCM) Special Education Settings (SES).
The participants of this study will be parents recruited through contact with Special Educational Settings designated for oral health promotion activity from the Special Care Dental Service. Parents invited to be included in the study will be parents of children aged 3 to 15 years, with a confirmed professional diagnosis of Autistic Spectrum Disorder.
Participants will be divided by schools into two groups of parents. Each group will be randomly assigned to either the mini MCM intervention or the 'Delivering Better Oral Health' intervention. A written consent form will be provided for participants. After receiving the information regarding the study participants will be given a minimum of 48 hours to consider the information supplied before deciding whether they would like to participate. Sample size calculation based on the measure of toothbrushing performance indicates a minimum requirement of 24 participants in each group. Two groups of 30 parents will be recruited considering that children may be lost to follow-up. Group 1 parents will receive the typical model of oral health education i.e. 'Delivering Better Oral Health' intervention, providing facts about why toothbrushing should occur and advice for their child aligned with the Public Health England and Department of Health document: "Delivering better oral health: an evidence-based toolkit for prevention".
Group 2 parents will be provided with a training session using the resources developed for Mini Mouth Care Matters SES, which include specific strategies to be considered and adopted for children who are resistant to toothbrushing. The training sessions for both groups will be followed up with weekly telephone sessions for three weeks, with the option of a face-to-face visit in place of one or more telephone sessions. Both groups will receive the same Tooth Care Pack containing a selection of toothbrushes and toothpastes.
A baseline of parental attitudes using the Oral Health Behaviours Questionnaire will be recorded.
Occurrence and severity of toothbrushing behaviour problems will be recorded at baseline and at the post training intervention three week follow-up using the 13-step assessment tool identifying steps completed by parents or children, or steps not possible to complete. Parents will also be asked to record time spent toothbrushing.
Results will be analysed to examine any inter- and intra-group differences in toothbrushing behaviour and parent confidence regarding their ability to influence their child's oral health by successfully delivering twice daily toothbrushing episodes for their autistic child.
The first national dental health survey for special schools in England shows that:
* At ages 5 and 12, compared to previous surveys in mainstream education, the proportion of children in special education with substantial plaque visible is almost double.
* Children aged 5 in special schools were twice as likely to have had one or more teeth extracted.
The Office of the Chief Dental Officer Special Education Settings Team has developed resources which focus on prevention for better oral health for children with learning disabilities, autism or both. Resources include information and tips to help parents and carers with frequent concerns such as: Am I using the right toothpaste? Have I got the right toothbrush? Is the environment right? Am I doing it right? The resources are available on the HEE hub e- Learning for Healthcare (e-LfH) through the link Mini Mouth Care Matters (Mini MCM) Special Education Settings (SES).
The participants of this study will be parents recruited through contact with Special Educational Settings designated for oral health promotion activity from the Special Care Dental Service. Parents invited to be included in the study will be parents of children aged 3 to 15 years, with a confirmed professional diagnosis of Autistic Spectrum Disorder.
Participants will be divided by schools into two groups of parents. Each group will be randomly assigned to either the mini MCM intervention or the 'Delivering Better Oral Health' intervention. A written consent form will be provided for participants. After receiving the information regarding the study participants will be given a minimum of 48 hours to consider the information supplied before deciding whether they would like to participate. Sample size calculation based on the measure of toothbrushing performance indicates a minimum requirement of 24 participants in each group. Two groups of 30 parents will be recruited considering that children may be lost to follow-up. Group 1 parents will receive the typical model of oral health education i.e. 'Delivering Better Oral Health' intervention, providing facts about why toothbrushing should occur and advice for their child aligned with the Public Health England and Department of Health document: "Delivering better oral health: an evidence-based toolkit for prevention".
Group 2 parents will be provided with a training session using the resources developed for Mini Mouth Care Matters SES, which include specific strategies to be considered and adopted for children who are resistant to toothbrushing. The training sessions for both groups will be followed up with weekly telephone sessions for three weeks, with the option of a face-to-face visit in place of one or more telephone sessions. Both groups will receive the same Tooth Care Pack containing a selection of toothbrushes and toothpastes.
A baseline of parental attitudes using the Oral Health Behaviours Questionnaire will be recorded.
Occurrence and severity of toothbrushing behaviour problems will be recorded at baseline and at the post training intervention three week follow-up using the 13-step assessment tool identifying steps completed by parents or children, or steps not possible to complete. Parents will also be asked to record time spent toothbrushing.
Results will be analysed to examine any inter- and intra-group differences in toothbrushing behaviour and parent confidence regarding their ability to influence their child's oral health by successfully delivering twice daily toothbrushing episodes for their autistic child.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: