Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 11:14 AM
Study NCT ID:
NCT05931094
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2023-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2023-06-26', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Responsiveness Scale', 'timeFrame': 'After 8 weeks', 'description': 'The Social Responsiveness Scale, Second Edition (SRS-2) measures social ability of children to adults. It is used primarily with individuals on the autism spectrum, family members of individuals on the autism spectrum, and others who have social impairments.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism', 'Augmented Reality', 'Social communication'], 'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '32847074', 'type': 'BACKGROUND', 'citation': 'Berenguer C, Baixauli I, Gomez S, Andres MEP, De Stasio S. Exploring the Impact of Augmented Reality in Children and Adolescents with Autism Spectrum Disorder: A Systematic Review. Int J Environ Res Public Health. 2020 Aug 24;17(17):6143. doi: 10.3390/ijerph17176143.'}, {'pmid': '28695116', 'type': 'BACKGROUND', 'citation': 'Liu R, Salisbury JP, Vahabzadeh A, Sahin NT. Feasibility of an Autism-Focused Augmented Reality Smartglasses System for Social Communication and Behavioral Coaching. Front Pediatr. 2017 Jun 26;5:145. doi: 10.3389/fped.2017.00145. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to determine the effects augmented reality game-based training on social communication of children with autism spectrum disorder.', 'detailedDescription': 'Augmented Reality allows children to see a representation of imaginary content and pretend play overlaid on the real-world environment. Today, technology can be a safe and motivating way of engaging children with autism in social interaction activities. Current research in therapeutic technology for autism is aimed toward improving behavior and psychomotor activities that impact social communication. The aim of this research project is to help teachers, parents, practitioners, and researchers to understand the unique strengths of their children with autism along with technology based educational and therapeutic activities for home and classroom.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following.\n\nExclusion Criteria:\n\n* Sensory issues and patients on medication.'}, 'identificationModule': {'nctId': 'NCT05931094', 'briefTitle': 'Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Augmented Reality Game-based Training on Social Communication of Children With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'F723 - Project B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AR group', 'description': 'Augmented Reality based games', 'interventionNames': ['Other: Augmented Reality based games']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional therapy group', 'description': 'Traditional therapy', 'interventionNames': ['Other: Traditional therapy']}], 'interventions': [{'name': 'Augmented Reality based games', 'type': 'OTHER', 'description': 'Games of Wonder Tree Augmented Reality', 'armGroupLabels': ['AR group']}, {'name': 'Traditional therapy', 'type': 'OTHER', 'description': 'Traditional therapy based on play activities utilizing blocks, colors, Velcro-based toys.', 'armGroupLabels': ['Traditional therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'AL', 'country': 'Pakistan', 'facility': 'Child Development Center', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Suman Sheraz, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}