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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04587557
Other study ID # HSEARS20160427001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2018

Study information

Verified date October 2020
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Storytelling with social contextual information
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 information
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.
Other:
Children with ASD
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.
Children with TD
Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.

Locations

Country Name City State
Hong Kong The Hong Kong Polytechnic University, Department of Rehabilitation Sciences Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eye gaze on the eye tracker Total fixation duration (TFD) Change from baseline to 4 weeks
Primary Eye gaze on the eye tracker Total visit duration (TVD) Change from baseline to 4 weeks
Primary Eye gaze on the eye tracker Total fixation count (TFC) Change from baseline to 4 weeks
Secondary Trail Making Test Trail Making Test A (TMT-A) Change from baseline to 4 weeks
Secondary Trail Making Test Trail Making Test B (TMT-B) Change from baseline to 4 weeks
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