NCT07166978

Brief Summary

Children with autism spectrum disorder (ASD) are more likely to have unmet dental needs. Due to hypersensitivity and oral defensiveness, new or unexpected stimuli during dental examinations often precipitate anxiety and stress. These dental barriers often exacerate the difficulties in managing ASD children during periodic comprehensive dental reviews, which are essential for prevention, early identification and management of oral problems, and maintenance of good oral health. Social story is a training approach constituting short stories and visual cues designed to convey information in a step-by-step manner, to help ASD children know what to expect and how to behave in different situations in daily life, and to gradually allow them to adjust to essential daily tasks. Our previous publications reported the success of social stories in improving oral health among ASD children, but its use in improving their experience in dental care and reducing their dental fear were only been validated in small-scale trials. Our team has developed and validated a dental-visit social story (DVSS) in collaboration with a review panel comprising of paediatric dentist, clinical psychiatrist and psychologist, speech and hearing therapist, dental practitioner, occupational therapist, social worker, and caregivers and teachers of ASD preschool children. A randomised controlled trial is conducted to compare and evaluate the clinical efficacy and cost benefits of DVSS among ASD preschool children. ASD preschool children are recruited and randomly allocated into two groups after baseline examination. Group 1 will receive class-integrated DVSS at baseline and then weekly class-integrated social story reinforcement sessions at the first two months, whereas Group 2 will receive 8 weekly social stories reinforcement on an unrelated topic. Both groups will be examined at 3, 6, 12 and 18 months with conventional non-pharmacological behavioural management techniques (CNPBMT). The outcome domains to be evaluated include the time required for the ASD preschool children to complete a compreheisve dental exams, their cooperativeness and anxiety levels during the dental examination, and cost benefits when class-integrated social stories were used with CNPBMT, versus CNPBMT alone. The knowledge generated can be translated into practice, addressing the current dental barriers and improving patient care among ASD children.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
33mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress34%
Jan 2025Dec 2028

First Submitted

Initial submission to the registry

November 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 11, 2025

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

November 10, 2024

Last Update Submit

September 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The mean appointment time required for the ASD children to complete each proportion of the comprehensive dental examinations

    Time required to examine for oral hygiene and dental caries

    at 3, 6, 12 and 18 months.

Secondary Outcomes (5)

  • The proportion of children being cooperative during comprehensive dental examination

    at 3, 6, 12 and 18 months.

  • The proportion of children achieving total cooperation during comprehensive dental examination

    at 3, 6, 12 and 18 months.

  • The mean percentage of comprehensive dental examination for oral hygiene and dental caries completed by ASD children within a 20-minute dental appointment time

    at 3, 6, 12 and 18 months.

  • Cost

    at 3, 6, 12 and 18 months.

  • Benefits

    at 3, 6, 12 and 18 months.

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will receive a validated social story ECOHC and reinforcement sessions after baseline recruitment. The developed and validated social story will be distributed to the participants in the intervention group. The same research assistant will visit their SCCCs 8 times to provide weekly class-integrated social story reinforcement sessions at 1-2 months. All children will receive dental examinations at their respective SCCCs at 3, 6, 12, 18 months.

Behavioral: Social story

Control

NO INTERVENTION

The control group will not receive any social story or reinforcement session throughout the study period. All children will receive dental examinations at their respective SCCCs at 3, 6, 12, 18 months.

Interventions

Social storyBEHAVIORAL

Social story is a training method constituting of short stories to convey information in a step-by-step manner, so that ASD children can understand what to expect and how to behave in different situations in daily lives. Social stories have been implemented to introduce dentistry and improve oral hygiene to individuals diagnosed with ASD with promising results. However, the certainty of evidence for its effectiveness in reducing dental fear during dental visit was low as the results were derived from small-scaled non-randomized controlled studies.

Intervention

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preschool children will be eligible if they have been diagnosed with ASD, following signed parental consent and completion of the questionnaire.
  • The proposed study will target Hong Kong preschool children diagnosed with ASD
  • Have their full primary dentition erupted
  • Able to understand and benefit from social stories (Gray, 2000).

You may not qualify if:

  • ASD children who have visual or hearing impairments
  • Whose parents who cannot read Chinese will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, The University of Hong Kong

Hong Kong, 999077, Hong Kong

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Phoebe Pui Ying Lam

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2024

First Posted

September 11, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

September 11, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available on request from the PI. The data are not publicly available as the containing information could compromise the privacy of research participants.

Locations