NCT04587557

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2.5 years

First QC Date

October 6, 2020

Last Update Submit

October 13, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Eye gaze on the eye tracker

    Total fixation duration (TFD)

    Change from baseline to 4 weeks

  • Eye gaze on the eye tracker

    Total visit duration (TVD)

    Change from baseline to 4 weeks

  • Eye gaze on the eye tracker

    Total fixation count (TFC)

    Change from baseline to 4 weeks

Secondary Outcomes (2)

  • Trail Making Test

    Change from baseline to 4 weeks

  • Trail Making Test

    Change from baseline to 4 weeks

Study Arms (4)

ASD Group 1 - storytelling with social contextual information

EXPERIMENTAL

Storytelling with social contextual information for children with Autism Spectrum Disorder

Behavioral: Storytelling with social contextual informationOther: Children with ASD

ASD Group 2 - storytelling without social contextual information

ACTIVE COMPARATOR

Storytelling without social contextual information for children with Autism Spectrum Disorder

Behavioral: Storytelling without social contextual informationOther: Children with ASD

TD Group 1 - storytelling with social contextual information

EXPERIMENTAL

Storytelling with social contextual information for typically developed children

Behavioral: Storytelling with social contextual informationOther: Children with TD

TD Group 2 - storytelling without social contextual information

ACTIVE COMPARATOR

Storytelling without social contextual information for typically developed children

Behavioral: Storytelling without social contextual informationOther: Children with TD

Interventions

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.

ASD Group 1 - storytelling with social contextual informationTD Group 1 - storytelling with 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.

ASD Group 2 - storytelling without social contextual informationTD Group 2 - storytelling without social contextual information

Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.

ASD Group 1 - storytelling with social contextual informationASD Group 2 - storytelling without social contextual information

Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.

TD Group 1 - storytelling with social contextual informationTD Group 2 - storytelling without social contextual information

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University, Department of Rehabilitation Sciences

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 14, 2020

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Upon request

Locations