- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04587557
Storytelling With or Without Social Contextual Information in Children With Autistic Spectrum Disorder and Typical Development
October 13, 2020 updated by: Kenneth N. K. Fong, The Hong Kong Polytechnic University
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria for children with ASD:
- 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
Inclusion Criteria for children with TD:
- 1) children aged between 6 and 12 years old;
- 2) had no developmental disorder or intellectual disability;
- 3) attended primary school.
Exclusion Criteria:
- NA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ASD Group 1 - storytelling with social contextual information
Storytelling with social contextual information for children with Autism Spectrum Disorder
|
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.
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.
|
|
Active Comparator: ASD Group 2 - storytelling without social contextual information
Storytelling without social contextual information for children with Autism Spectrum Disorder
|
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.
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.
|
|
Experimental: TD Group 1 - storytelling with social contextual information
Storytelling with social contextual information for typically developed children
|
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.
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.
|
|
Active Comparator: TD Group 2 - storytelling without social contextual information
Storytelling without social contextual information for typically developed children
|
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.
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eye gaze on the eye tracker
Time Frame: Change from baseline to 4 weeks
|
Total fixation duration (TFD)
|
Change from baseline to 4 weeks
|
|
Eye gaze on the eye tracker
Time Frame: Change from baseline to 4 weeks
|
Total visit duration (TVD)
|
Change from baseline to 4 weeks
|
|
Eye gaze on the eye tracker
Time Frame: Change from baseline to 4 weeks
|
Total fixation count (TFC)
|
Change from baseline to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trail Making Test
Time Frame: Change from baseline to 4 weeks
|
Trail Making Test A (TMT-A)
|
Change from baseline to 4 weeks
|
|
Trail Making Test
Time Frame: Change from baseline to 4 weeks
|
Trail Making Test B (TMT-B)
|
Change from baseline to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
October 6, 2020
First Submitted That Met QC Criteria
October 13, 2020
First Posted (Actual)
October 14, 2020
Study Record Updates
Last Update Posted (Actual)
October 14, 2020
Last Update Submitted That Met QC Criteria
October 13, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20160427001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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