Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-05 @ 5:49 PM
Study NCT ID:
NCT04587557
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Storytelling With or Without Social Contextual Information in Children With Autistic Spectrum Disorder and Typical Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-13', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-13', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eye gaze on the eye tracker', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Total fixation duration (TFD)'}, {'measure': 'Eye gaze on the eye tracker', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Total visit duration (TVD)'}, {'measure': 'Eye gaze on the eye tracker', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Total fixation count (TFC)'}], 'secondaryOutcomes': [{'measure': 'Trail Making Test', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Trail Making Test A (TMT-A)'}, {'measure': 'Trail Making Test', 'timeFrame': 'Change from baseline to 4 weeks', 'description': 'Trail Making Test B (TMT-B)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '33909213', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for children with ASD:\n\n* 1\\) children aged between 6 and 12 years old;\n* 2\\) had a previous diagnosis of ASD from medical professionals;\n* 3\\) studied in mainstream primary school;\n* 4\\) had a composite IQ score of 80 or above\n\nInclusion Criteria for children with TD:\n\n* 1\\) children aged between 6 and 12 years old;\n* 2\\) had no developmental disorder or intellectual disability;\n* 3\\) attended primary school.\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT04587557', 'briefTitle': 'Storytelling With or Without Social Contextual Information in Children With Autistic Spectrum Disorder and Typical Development', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HSEARS20160427001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASD Group 1 - storytelling with social contextual information', 'description': 'Storytelling with social contextual information for children with Autism Spectrum Disorder', 'interventionNames': ['Behavioral: Storytelling with social contextual information', 'Other: Children with ASD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ASD Group 2 - storytelling without social contextual information', 'description': 'Storytelling without social contextual information for children with Autism Spectrum Disorder', 'interventionNames': ['Behavioral: Storytelling without social contextual information', 'Other: Children with ASD']}, {'type': 'EXPERIMENTAL', 'label': 'TD Group 1 - storytelling with social contextual information', 'description': 'Storytelling with social contextual information for typically developed children', 'interventionNames': ['Behavioral: Storytelling with social contextual information', 'Other: Children with TD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TD Group 2 - storytelling without social contextual information', 'description': 'Storytelling without social contextual information for typically developed children', 'interventionNames': ['Behavioral: Storytelling without social contextual information', 'Other: Children with TD']}], 'interventions': [{'name': 'Storytelling with social contextual information', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['ASD Group 1 - storytelling with social contextual information', 'TD Group 1 - storytelling with social contextual information']}, {'name': 'Storytelling without social contextual information', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['ASD Group 2 - storytelling without social contextual information', 'TD Group 2 - storytelling without social contextual information']}, {'name': 'Children with ASD', 'type': 'OTHER', 'description': 'Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.', 'armGroupLabels': ['ASD Group 1 - storytelling with social contextual information', 'ASD Group 2 - storytelling without social contextual information']}, {'name': 'Children with TD', 'type': 'OTHER', 'description': 'Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.', 'armGroupLabels': ['TD Group 1 - storytelling with social contextual information', 'TD Group 2 - storytelling without social contextual information']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Hong Kong Polytechnic University, Department of Rehabilitation Sciences', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kenneth N. K. Fong', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}