Autism Spectrum DisorderNCT07166978
Improving Autistic Children's Experiences of Dental Care With Class-integrated Social Story
A study testing Social story in people with Autism Spectrum Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Social story
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- ASD children who have visual or hearing impairments
- Whose parents who cannot read Chinese will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, The University of Hong Kong
Hong Kong, 999077
Pui Ying Phoebe Lam, +85228590578, pyphoebe@hku.hk
About this study
Official title: Improving Autistic Children's Experiences of Dental Care With Class-integrated Social Story: a Randomised Controlled Trial and Cost-benefit Analysis
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.
Read more
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.
Read the detailed description
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
- Autism Spectrum Disorder
- Being tested
- Social story
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social storyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 3, 6, 12 and 18 months.
Secondary outcomes (5)
The proportion of children being cooperative during comprehensive dental examination
Evaluated by Frankl behavioural rating scale (FS) (Frankl, Shiere, \& Fogels, 1962). The proportion of children achieving Frankl scale of 3 or 4.
Measured: at 3, 6, 12 and 18 months.
The proportion of children achieving total cooperation during comprehensive dental examination
Evaluated by Venham behavioural rating scale (VS) (Venham et al., 1980). The proportion of children scoring "0" on VS score, i.e. total cooperation
Measured: 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
The dental examination is subdivided into examination of (i) oral hygiene and (ii) dental caries. For oral hygiene, the number of index tooth surfaces that can be examined is recorded divided by 12 index surfaces. Whereas for dental caries, the number of teeth and surfaces that can be viewed and assessed for decay will be divided by 20 primary teeth and 100 surfaces. The mean percentage of the two groups in oral hygiene and dental caries assessment will be compared.
Measured: at 3, 6, 12 and 18 months.
Cost
The overall cost (CCISS) of implementing the class-integrated social stories will be calculated with a bottom-up estimation, including the production cost of the social stories, training cost and implementation cost (CI) with the reinforcement sessions. The implementation cost (CI) is estimated by multiplying the number and duration of the reinforcement sessions with salary of the research assistant (SRA).
Measured: at 3, 6, 12 and 18 months.
Benefits
Assuming that when the ASD children cannot complete over 80% of the comprehensive examination, at least one additional dental appointment has to be rescheduled. At each examination timepoint (3, 6, 12, 18 months), the comparative benefits include (1) the cost savings for an additional appointment, calculated by multiplying the proportion of children who cannot complete 80% of the comprehensive examination by the duration of each additional appointment (20 minutes) along with the wages of the dentist and chairside assistant, as well as adding the material cost; (2) cost savings resulting from a reduction in the average appointment time, calculated by multiplying the mean reduction in time by the combined salaries of the dentist and chairside assistant. As social stories reinforcement and dental examinations will be conducted during class in SCCCs, indirect cost and benefits from the carers' perspective for carers of ASD children will not be considered in this CBA.
Measured: at 3, 6, 12 and 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166978
- Sponsor's protocol ID
- UW24-535
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Autistic Children's Experiences of Dental Care With Class-integrated Social Story: a Randomised Controlled Trial and Cost-benefit Analysis
- ClinicalTrials.gov ID
- NCT07166978
- Acronym / sponsor ID
- UW24-535
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Social storyThe 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. |
| 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- ASD children who have visual or hearing impairments
- Whose parents who cannot read Chinese will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social storySocial 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. | Behavioural | Intervention |
Primary outcome
The mean appointment time required for the ASD children to complete each proportion of the comprehensive dental examinations
Time frame: at 3, 6, 12 and 18 months.
Time required to examine for oral hygiene and dental caries
5 secondary outcomes
The proportion of children being cooperative during comprehensive dental examination
Time frame: at 3, 6, 12 and 18 months.
The proportion of children achieving total cooperation during comprehensive dental examination
Time frame: 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
Time frame: at 3, 6, 12 and 18 months.
Cost
Time frame: at 3, 6, 12 and 18 months.
Benefits
Time frame: at 3, 6, 12 and 18 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social story in people with Autism Spectrum Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phoebe Pui Ying Lam (+852 28590578, pyphoebe@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean appointment time required for the ASD children to complete each proportion of the comprehensive dental examinations (time frame: at 3, 6, 12 and 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.