Autism Spectrum DisorderNCT04587557

Storytelling With or Without Social Contextual Information in Children With Autistic Spectrum Disorder and Typical Development

A study testing Storytelling with social contextual information, Storytelling without social contextual information and Children with ASD in people with Autism Spectrum Disorder and Healthy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was to examine the effects of storytelling with or without contextual information on children with autism spectrum disorder (ASD) and typical development (TD). Read more about this study

Who is it for?: Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Autism Spectrum Disorder, Healthy
What is being tested?: Storytelling with social contextual information, Storytelling without social contextual information and Children with ASD
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteHong Kong
Study dates: Jun 2016to Dec 2018
Phase: Interventional
Are there results?: None posted in the registry

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 6 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

1) children aged between 6 and 12 years old;
2) had a previous diagnosis of ASD from medical professionals;
3) studied in mainstream primary school;
4) had a composite IQ score of 80 or above
1) children aged between 6 and 12 years old;
2) had no developmental disorder or intellectual disability;
3) attended primary school.

Who cannot join

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Hong Kong

Other trials in Hong Kong

About this study

Official title: The Effects of Storytelling With or Without Social Contextual Information Regarding Eye Gaze and Visual Attention in Children With Autistic Spectrum Disorder and Typical Development: A Randomized, Controlled Eye-tracking Study

This study was to examine the effects of storytelling with or without contextual information on children with autism spectrum disorder (ASD) and typical development (TD).

Read the detailed description

This was a 2 x 2 x 2 randomized controlled trial with 52 children (26 with ASD and 26 with TD) recruited in the community and randomized into four groups: 1) ASD Group 1 - storytelling with contextual information; 2) ASD Group 2 - storytelling without contextual information; 3) TD Group 1 - storytelling with contextual information; 4) TD Group 2 - storytelling without contextual information. All stories were photo-based and static in nature. The only difference between Group 1 and Group 2 was that the stories included and did not include social contextual information, respectively. Training was delivered in small groups, with eight sessions across four weeks, two sessions per week, and 30 minutes per session. Participants' total fixation duration (TFD), total visit duration (TVD), and total fixation count (TFC) on human faces from 20 photos and a video were recorded using the Tobii eye tracker.

Conditions: Autism Spectrum Disorder, Healthy
Being tested: Storytelling with social contextual information, Storytelling without social contextual information, Children with ASD, Children with TD
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.

Storytelling with social contextual informationBehavioural
Four out of 100 stories from a storytelling app (SAHK, 2013) that incorporated social contextual information, and inter-personal skills were selected. The intervention was in small group format, consisted of eight sessions across four weeks, two sessions per week, 30 minutes per session.
Storytelling without social contextual informationBehavioural
Four out of 100 stories from a storytelling app (SAHK, 2013) without social contextual information, and inter-personal skills were selected. The intervention was in small group format, consisted of eight sessions across four weeks, two sessions per week, 30 minutes per session.
Children with ASDOther
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.
Children with TDOther
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.

Study groups in NCT04587557
Study group	Role	What they receive
ASD Group 1 - storytelling with social contextual information	Experimental	Storytelling with social contextual information for children with Autism Spectrum Disorder Receives: Behavioral: Storytelling with social contextual information; Other: Children with ASD
ASD Group 2 - storytelling without social contextual information	Active comparator	Storytelling without social contextual information for children with Autism Spectrum Disorder Receives: Behavioral: Storytelling without social contextual information; Other: Children with ASD
TD Group 1 - storytelling with social contextual information	Experimental	Storytelling with social contextual information for typically developed children Receives: Behavioral: Storytelling with social contextual information; Other: Children with TD
TD Group 2 - storytelling without social contextual information	Active comparator	Storytelling without social contextual information for typically developed children Receives: Behavioral: Storytelling without social contextual information; Other: Children with TD

What is being measured

The primary outcome is the main question the study is designed to answer.

Eye gaze on the eye tracker
Total fixation duration (TFD)
Measured: Change from baseline to 4 weeks
Eye gaze on the eye tracker
Total visit duration (TVD)
Measured: Change from baseline to 4 weeks
Eye gaze on the eye tracker
Total fixation count (TFC)
Measured: Change from baseline to 4 weeks

Secondary outcomes (2)

Trail Making Test
Trail Making Test A (TMT-A)
Measured: Change from baseline to 4 weeks
Trail Making Test
Trail Making Test B (TMT-B)
Measured: Change from baseline to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Dec 2018

First posted14 Oct 2020
Study startJun 2016
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by The Hong Kong Polytechnic UniversityThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04587557
Sponsor's protocol ID: HSEARS20160427001
Status last verified: Oct 2020
First submitted: 6 Oct 2020
Last updated: 14 Oct 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Upon request

Publications

Tang WYF, Fong KNK, Chung RCK. The Effects of Storytelling With or Without Social Contextual Information Regarding Eye Gaze and Visual Attention in Children with Autistic Spectrum Disorder and Typical Development: A Randomized, Controlled Eye-Tracking Study. J Autism Dev Disord. 2022 Mar;52(3):1257-1267. doi: 10.1007/s10803-021-05012-w. Epub 2021 Apr 28.
PubMed 33909213

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Storytelling With or Without Social Contextual Information Regarding Eye Gaze and Visual Attention in Children With Autistic Spectrum Disorder and Typical Development: A Randomized, Controlled Eye-tracking Study
ClinicalTrials.gov ID: NCT04587557
Acronym / sponsor ID: HSEARS20160427001
Conditions: Autism Spectrum Disorder, Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: Jun 2016 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 14 Oct 2020 (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.

This study was to examine the effects of storytelling with or without contextual information on children with autism spectrum disorder (ASD) and typical development (TD).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
ASD Group 1 - storytelling with social contextual information	Experimental	Behavioral: Storytelling with social contextual information, Other: Children with ASDStorytelling with social contextual information for children with Autism Spectrum Disorder
ASD Group 2 - storytelling without social contextual information	Active comparator	Behavioral: Storytelling without social contextual information, Other: Children with ASDStorytelling without social contextual information for children with Autism Spectrum Disorder
TD Group 1 - storytelling with social contextual information	Experimental	Behavioral: Storytelling with social contextual information, Other: Children with TDStorytelling with social contextual information for typically developed children
TD Group 2 - storytelling without social contextual information	Active comparator	Behavioral: Storytelling without social contextual information, Other: Children with TDStorytelling without social contextual information for typically developed children

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

1) children aged between 6 and 12 years old;
2) had a previous diagnosis of ASD from medical professionals;
3) studied in mainstream primary school;
4) had a composite IQ score of 80 or above
1) children aged between 6 and 12 years old;

Key exclusion criteria (1 listed)

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
Storytelling with social contextual informationFour out of 100 stories from a storytelling app (SAHK, 2013) that incorporated social contextual information, and inter-personal skills were selected. The intervention was in small group format, consisted of eight sessions across four weeks, two sessions per week, 30 minutes per session.	Behavioural	ASD Group 1 - storytelling with social contextual information, TD Group 1 - storytelling with social contextual information
Storytelling without social contextual informationFour out of 100 stories from a storytelling app (SAHK, 2013) without social contextual information, and inter-personal skills were selected. The intervention was in small group format, consisted of eight sessions across four weeks, two sessions per week, 30 minutes per session.	Behavioural	ASD Group 2 - storytelling without social contextual information, TD Group 2 - storytelling without social contextual information
Children with ASDFour out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.	Other	ASD Group 1 - storytelling with social contextual information, ASD Group 2 - storytelling without social contextual information
Children with TDFour out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.	Other	TD Group 1 - storytelling with social contextual information, TD Group 2 - storytelling without social contextual information

Primary outcome

Eye gaze on the eye tracker
Time frame: Change from baseline to 4 weeks
Total fixation duration (TFD)
Eye gaze on the eye tracker
Time frame: Change from baseline to 4 weeks
Total visit duration (TVD)
Eye gaze on the eye tracker
Time frame: Change from baseline to 4 weeks
Total fixation count (TFC)

2 secondary outcomes

Trail Making Test
Time frame: Change from baseline to 4 weeks
Trail Making Test
Time frame: Change from baseline to 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
Derived from this study: PubMed 33909213Tang WYF, Fong KNK, Chung RCK. The Effects of Storytelling With or Without Social Contextual Information Regarding Eye Gaze and Visual Attention in Children with Autistic Spectrum Disorder and Typical Development: A Randomized, Controlled Eye-Tracking Study. J Autism Dev Disord. 2022 Mar;52(3):1257-1267. doi: 10.1007/s10803-021-05012-w. Epub 2021 Apr 28.
Individual participant dataSharing planned: No. Upon request

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RecruitingPhase 3
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 1 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: finished, as of the sponsor's last update on 14 Oct 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eye gaze on the eye tracker (time frame: Change from baseline to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04587557, which also lists 1 linked publication.

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 14 Oct 2020.