Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 5:46 PM
Study NCT ID:
NCT07377227
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Social COgnition Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'differences in visual exploration patterns between both groups', 'timeFrame': '2 years', 'description': "Differences in visual exploration patterns between both groups Visual exploration patterns are determined with TOM Test Battery, PPVT-5, Raven's 2 and FEE tests"}, {'measure': 'Classification performance of machine learning algorithms in distinguishing ASD from TD', 'timeFrame': '2 years', 'description': 'Classification performance of machine learning algorithms in distinguishing ASD from TD'}], 'secondaryOutcomes': [{'measure': 'Correlations between eye-tracking measures and cognitive scores', 'timeFrame': '2 years', 'description': "Eye-tracking patterns are determined with TOM Test Battery, PPVT-5, Raven's 2 and FEE tests"}, {'measure': 'Developmental trajectory analysis in TD children', 'timeFrame': '2 years'}, {'measure': 'Identification of cognitive subgroups within ASD group', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eye-tracking', 'Autism Spectrum Disorder', 'Social Cognition', 'Diagnosis'], 'conditions': ['Eye-tracking', 'Autism Spectrum Disorder', 'Social Cognition', 'Diagnosis']}, 'descriptionModule': {'briefSummary': "Social cognition refers to the mental processes involved in social interactions, including social perception, motivation, communication, emotion recognition, and theory of mind. Face perception plays a key role in children's social development, but children with Autism Spectrum Disorder (ASD) tend to look less at social stimuli, especially faces, than typically developing (TD) peers. Eye-tracking studies highlight these visual exploration differences, linked to difficulties in joint attention, emotion recognition, and theory of mind, as well as in executive and memory functions. Standard diagnostic tests often require active participation and sufficient language, which makes assessment challenging for children with ASD and additional cognitive or language impairments.\n\nThis research project investigates how visual activity supports social cognition depending on cognitive and language levels, hypothesizing that eye-tracking can provide useful indicators for ASD screening and diagnosis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASD Group:\n* Boys or girls diagnosed with Autism Spectrum Disorder (based on clinical tools and observations)\n* Aged between 4 and 10 years old\n* Affiliation with a social security scheme\n* Informed consent of those with parental authority\n* DT Group:\n* Boys or girls\n* Aged between 4 and 10\n* Attending school in the Hauts-de-France region\n* Affiliation with a social security scheme\n* Consent of those with parental authority\n\nExclusion Criteria:\n\n* For ASD: Uncorrected visual or auditory impairments.\n* For DT: Intellectual disability, neurological or genetic disorders, autistic traits reported by teachers. The discrepancy between actual age and abilities calculated on the basis of standardised test scores'}, 'identificationModule': {'nctId': 'NCT07377227', 'acronym': 'ECoS-A', 'briefTitle': 'Social COgnition Screening', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Evaluation of Social Cognition: A New Screening Approach for Autism', 'orgStudyIdInfo': {'id': 'PI2025_843_0181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autism Spectrum Disorder', 'description': 'Autism Spectrum Disorder', 'interventionNames': ['Other: eye-tracking', 'Other: cognitive assessments']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'typically developing peers', 'description': 'typically developing (TD) peers', 'interventionNames': ['Other: eye-tracking', 'Other: cognitive assessments']}], 'interventions': [{'name': 'eye-tracking', 'type': 'OTHER', 'description': 'eye-tracking', 'armGroupLabels': ['Autism Spectrum Disorder', 'typically developing peers']}, {'name': 'cognitive assessments', 'type': 'OTHER', 'description': 'cognitive assessments', 'armGroupLabels': ['Autism Spectrum Disorder', 'typically developing peers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'contacts': [{'name': 'Federica Cilia, MD', 'role': 'CONTACT', 'email': 'Cilia.Federica-ext@chu-amiens.fr', 'phone': '33+3 22 66 75 40'}, {'name': 'Sébastien Garny De La Rivière, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Amiens hospital', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Federica Cilia, MD', 'role': 'CONTACT', 'email': 'Cilia.Federica-ext@chu-amiens.fr', 'phone': '33+3 22 66 75 40'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}