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

Primary Purpose

Autism Spectrum Disorder, Healthy

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Storytelling with social contextual information
Storytelling without social contextual information
Children with ASD
Children with TD
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Hong Kong Polytechnic University, Department of Rehabilitation Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

ASD Group 1 - storytelling with social contextual information

ASD Group 2 - storytelling without social contextual information

TD Group 1 - storytelling with social contextual information

TD Group 2 - storytelling without social contextual information

Arm Description

Storytelling with social contextual information for children with Autism Spectrum Disorder

Storytelling without social contextual information for children with Autism Spectrum Disorder

Storytelling with social contextual information for typically developed children

Storytelling without social contextual information for typically developed children

Outcomes

Primary Outcome Measures

Eye gaze on the eye tracker
Total fixation duration (TFD)
Eye gaze on the eye tracker
Total visit duration (TVD)
Eye gaze on the eye tracker
Total fixation count (TFC)

Secondary Outcome Measures

Trail Making Test
Trail Making Test A (TMT-A)
Trail Making Test
Trail Making Test B (TMT-B)

Full Information

First Posted
October 6, 2020
Last Updated
October 13, 2020
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT04587557
Brief Title
Storytelling With or Without Social Contextual Information in Children With Autistic Spectrum Disorder and Typical Development
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASD Group 1 - storytelling with social contextual information
Arm Type
Experimental
Arm Description
Storytelling with social contextual information for children with Autism Spectrum Disorder
Arm Title
ASD Group 2 - storytelling without social contextual information
Arm Type
Active Comparator
Arm Description
Storytelling without social contextual information for children with Autism Spectrum Disorder
Arm Title
TD Group 1 - storytelling with social contextual information
Arm Type
Experimental
Arm Description
Storytelling with social contextual information for typically developed children
Arm Title
TD Group 2 - storytelling without social contextual information
Arm Type
Active Comparator
Arm Description
Storytelling without social contextual information for typically developed children
Intervention Type
Behavioral
Intervention Name(s)
Storytelling with social contextual information
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Storytelling without social contextual information
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Children with ASD
Intervention Description
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.
Intervention Type
Other
Intervention Name(s)
Children with TD
Intervention Description
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.
Primary Outcome Measure Information:
Title
Eye gaze on the eye tracker
Description
Total fixation duration (TFD)
Time Frame
Change from baseline to 4 weeks
Title
Eye gaze on the eye tracker
Description
Total visit duration (TVD)
Time Frame
Change from baseline to 4 weeks
Title
Eye gaze on the eye tracker
Description
Total fixation count (TFC)
Time Frame
Change from baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Trail Making Test
Description
Trail Making Test A (TMT-A)
Time Frame
Change from baseline to 4 weeks
Title
Trail Making Test
Description
Trail Making Test B (TMT-B)
Time Frame
Change from baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Upon request
Citations:
PubMed Identifier
33909213
Citation
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.
Results Reference
derived

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

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