Improving Autistic Children's Experiences of Dental Care With Class-integrated Social Story

NCT ID: NCT07166978

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Interventions The intervention group will receive a validated social story ECOHC and reinforcement sessions after baseline recruitment. The control group will not receive any social story or reinforcement session throughout the study period. The randomisation ratio is 1:1.

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, then the class-integrated social story ECOHC reinforcement will be discontinued. The visiting research assistant will receive training from the team's clinical psychologist, speech-and-hearing therapist, and occupational therapist for the reinforcement sessions.

Oral examinations and NPBBMT for intervention and control groups All children in both groups will receive dental examinations at their respective SCCCs at 3, 6, 12, 18 months. Kindergarten tables lined with mattress and pillows will be set up, and children will be asked to lie supine for oral visual examination using a blunt probe and a disposable front-surface dental mirror attached to light-emitting diode for intra-oral illumination with a disposable plastic sleeve. All examinations will be performed by one single dentist wearing Personal Protective Equipment implementing a standardised protocol of conventional non-pharmacological basic behavioural management techniques (CNPBMT), The time required from the participants being called for examination to completion of the examination will be recorded. If the children continue to refuse to open their mouths and cooperate within the 20-minute appointment time with the standardised CNPBMT employed, no further attempt will be made to perform the examination.

Visible plaque index (VPI) will be first used to assess the baseline oral hygiene level (Ainamo \& Bay, 1975). Caries status will be assessed by two parameters: caries diagnostic criteria recommended by WHO (2013), and the modified International Caries Detection and Assessment System (ICDAS). All tooth surfaces will be first wiped clean and dried using a clean gauze and cotton swab before visual inspection of caries. Basic dental charting will be performed, and the overall primary dentition will be recorded.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

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.

Group Type EXPERIMENTAL

Social story

Intervention Type BEHAVIORAL

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Social story

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 Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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).

Exclusion Criteria

* ASD children who have visual or hearing impairments
* Whose parents who cannot read Chinese will be excluded.
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Phoebe Pui Ying Lam

Role: CONTACT

+852 28590578

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pui Ying Phoebe Lam

Role: primary

+85228590578

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UW24-535

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.