NCT06855693

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

February 19, 2025

Last Update Submit

March 20, 2025

Conditions

Keywords

oral healthchildrenautism

Outcome Measures

Primary Outcomes (2)

  • The 13-step toothbrushing assessment tool

    The 13-step assessment tool identifies steps completed by parents or children, or steps not possible to complete. Parents will also be asked to record time spent toothbrushing.

    baseline and immediately after the intervention

  • The validated Parental-Caregiver Current Oral Health Behaviours Questionnaire (OHBQ).

    The OHBQ has been developed to measure attitudes and beliefs of parents around their child's dental health. A section to capture demographic data, with questions utilised in previous studies, has been incorporated in the questionnaire sheet above the OHBQ to explore oral health inequalities associated with socioeconomic status, which are widely observed in the literature6.

    baseline

Study Arms (2)

Delivering better oral health: an evidence-based toolkit for prevention

EXPERIMENTAL

The PHE Delivering Better Oral Health toolkit has been developed with the support of the 4 UK Chief Dental Officers. This is a general population approach to Oral Hygiene advice and includes the following: Effective toothbrushing with a fluoride toothpaste is important to support oral health. The physical action of brushing removes plaque, which prevents gingivitis and periodontitis, and the fluoride in toothpaste is effective against tooth decay. The following key messages for the population include when and how to brush, specific habits associated with brushing, and, where necessary, assistance with brushing. There may be adaptations of toothbrushes, such as special grip handles, that are helpful to people who have limited manual dexterity.

Behavioral: Delivering better oral health: an evidence-based toolkit for prevention

Mini Mouth Care Matters guide for special Education Settings

EXPERIMENTAL

Oral hygiene guidance from a Clinical standard for autistic children and young people and/or those with a learning disability in special educational settings (Mini Mouth Care Matters Special Education Settings resources. This is a specific approach to providing Oral Hygiene for children with sensory challenges. This clinical standard supports the vision of universal access whereby everyone receives quality health services that meet their specific needs. The clinical standard is designed to be used by all those involved in improving health outcomes and quality of life, including eating, speaking and socialising, for autistic children and young people, and those with a learning disability in England. It is accompanied by a supporting package of tools, resources, and modules to support the delivery of the oral healthcare assessment (either face to face or remote) and to support teams in the development o

Behavioral: Mini Mouth Care Matters guide for special Education Settings

Interventions

The PHE Delivering Better Oral Health toolkit has been developed with the support of the 4 UK Chief Dental Officers. This is a general population approach to Oral Hygiene advice and includes the following: Effective toothbrushing with a fluoride toothpaste is important to support oral health. The physical action of brushing removes plaque, which prevents gingivitis and periodontitis, and the fluoride in toothpaste is effective against tooth decay. The following key messages for the population include when and how to brush, specific habits associated with brushing, and, where necessary, assistance with brushing. There may be adaptations of toothbrushes, such as special grip handles, that are helpful to people who have limited manual dexterity.

Delivering better oral health: an evidence-based toolkit for prevention

2\. Oral hygiene guidance from a Clinical standard for autistic children and young people and/or those with a learning disability in special educational settings (Mini Mouth Care Matters Special Education Settings resources. This is a specific approach to providing Oral Hygiene for children with sensory challenges. This clinical standard supports the vision of universal access whereby everyone receives quality health services that meet their specific needs. The clinical standard is designed to be used by all those involved in improving health outcomes and quality of life, including eating, speaking and socialising, for autistic children and young people, and those with a learning disability in England. It is accompanied by a supporting package of tools, resources, and modules to support the delivery of the oral healthcare assessment (either face to face or remote) and to support teams in the development of complementary tailored mouthcare plans.

Mini Mouth Care Matters guide for special Education Settings

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent/Carer of an autistic child aged between 3 and 15 years Parent/Carer of an autistic child attending a Special Education Setting Parent/Carer with capacity to provide consent

You may not qualify if:

  • Parent/Carer that cannot adequately understand verbal explanations or information written in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sussex Community NHS Foundation Trust

Brighton, East Sussex, BN2 3EW, United Kingdom

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jennifer Parry, FDS RCS(Paeds) MDentSci BDS

    Sussex Community NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2025

First Posted

March 4, 2025

Study Start

January 3, 2024

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations