Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 11:44 PM
Study NCT ID:
NCT06339359
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007700', 'term': 'Kinetics'}], 'ancestors': [{'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'K-BSID-Ⅲ', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of K-BSID-Ⅲ is a developmental test administered to infants from 16 days old to 42 months old, and consists of 16 subtests measuring a total of 5 development areas (cognitive, language, motor, social-emotional, and adaptive behavior).'}, {'measure': 'ADI-R', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of ADI-R is a test conducted to screen autism spectrum disorder from other developmental disabilities in children with a mental age of 2 years or older, and is conducted through a structured interview with the primary caregiver.'}, {'measure': 'M-CHAT', 'timeFrame': 'Between March 2024 and March 2025', 'description': "Measurement of M-CHAT is a tool to screen the risk level of autism spectrum disorder in children aged 16 to 30 months and is evaluated based on the primary caregiver's report."}, {'measure': 'ADOS-2', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of ADOS-2 is a standardized assessment tool that evaluates social interaction and stereotyped and repetitive behavior in people suspected of having autism spectrum disorder.'}, {'measure': 'K-WPPSI-Ⅳ', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of K-WPPSI-Ⅳ is an intelligence test to evaluate cognitive function in children aged 2 years and 6 months to 7 years and 7 months.'}, {'measure': 'K-CARS-2', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of K-CARS-2 is an one of the most widely used tools for the purpose of distinguishing autism from other developmental disabilities and the degree of autism.'}, {'measure': 'CBCL', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of CBCL is a useful clinical tool used in many countries around the world to evaluate social adaptation and emotional behavior problems in children and adolescents.'}, {'measure': 'SCQ', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of SCQ is a tool to screen symptoms related to autism spectrum disorder through parent report.'}, {'measure': 'GMFM', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of GMFM is a standardized observational evaluation tool with validity that measures changes in gross motor function over time in children with cerebral palsy.'}, {'measure': 'HFT', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of HFT is a tool to evaluate the degree of development of hand function according to age, forward arm reaching, various grasping abilities, coordination ability between both hands, and object handling ability.'}, {'measure': 'BOT-2', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of BOT-2 is a testing tool used for movement training evaluation and development.'}, {'measure': 'VMI-6', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of VMI-6 is a test that validly measures the visual-motor integration ability, visual perception ability, and motor coordination ability of various age groups from infants to adults.'}, {'measure': 'SP', 'timeFrame': 'Between March 2024 and March 2025', 'description': "Measurement of SP is a standardized tool for assessing children's sensory processing patterns in the context of everyday life, providing unique information about how sensory processing supports or hinders participation."}, {'measure': 'Eye Tracking', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'While the subject watches the video material being played, gaze and behavioral data are recorded.'}, {'measure': 'Motion Analysis', 'timeFrame': 'Between March 2024 and March 2025', 'description': 'Measurement of Motion analysis is an evaluation process of the research subject is filmed while administering ADOS and RBS-EC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ASD']}, 'descriptionModule': {'briefSummary': 'This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.', 'detailedDescription': 'This study aims to collect basic data to develop a tool for early screening of autism spectrum disorder (ASD) in children and adolescents through eye tracking and motion analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and adolescents volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children and adolescents under the age of 19 at the time of registration\n* A person whose legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after receiving a detailed explanation of this study and fully understanding it\n\nExclusion Criteria:\n\n* Those with abnormalities in hearing and vision\n* Those who are likely to have difficulty participating in the study according to the judgment of the clinical investigator\n* If the visits set out in this research plan are not followed or the patient's guardian does not cooperate due to low understanding of the patient."}, 'identificationModule': {'nctId': 'NCT06339359', 'briefTitle': 'A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Bundang CHA Hospital'}, 'officialTitle': 'A Pilot Study to Develop a Behavior-based Screening Protocol for Early Diagnosis of Autism Spectrum Disorders', 'orgStudyIdInfo': {'id': '2024-02-014'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Exmainations including clinical measurement, kinetic and kinematic measurmetns. Behavioral assessments', 'type': 'OTHER', 'description': 'Collection of clinical data including K-Bayley Scales of Infant and Toddler Development Third Edition (K-BSID-Ⅲ), , Beery-Buktenica Visual-Motor Integration, Sixth Edition (VMI-6) and clinical measurement. motor analysis and eye tracking'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-712', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Minyoung Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'kmin@cha.ac.kr', 'phone': '82-31-780-1872'}], 'facility': 'CHA Bundang Medical Center, CHA University', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Kim MinYoung', 'role': 'CONTACT', 'email': 'kmin@cha.ac.kr', 'phone': '82-31-780-6281'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bundang CHA Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'MinYoung Kim, MD, PhD', 'investigatorAffiliation': 'Bundang CHA Hospital'}}}}