[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593477":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":173,"collaborators":175,"id":193,"slug":194,"hasResults":195,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":10,"eligibilityCriteria":199,"healthyVolunteers":200,"sex":201,"minAge":202,"maxAge":203,"enrollmentInfo":204,"targetDuration":207,"studyType":208,"phases":10,"briefSummary":209,"conditions":210,"keywords":10,"overallStatus":214,"whyStopped":10,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":219,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"ASD group",null,"This group includes toddlers diagnosed with autism spectrum disorder aged between 1.5 to 2.5 years old.",[13,14],"Diagnostic Test: Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2)","Diagnostic Test: Griffiths Developmental Scales, Chinese edition(GDS-C)",{"label":16,"type":10,"description":17,"interventionNames":18},"GDD group","This group includes toddlers diagnosed with global development disorder aged between 1.5 to 2.5 years old.",[14],{"label":20,"type":10,"description":21,"interventionNames":22},"LD group","This group includes toddlers diagnosed with language disorder aged between 1.5 to 2.5 years old.",[14],{"label":24,"type":10,"description":25,"interventionNames":26},"TD group","This group includes typically developing toddlers aged between 1.5 to 2.5 years old.",[14],[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"DIAGNOSTIC_TEST","Autism Diagnostic Observation Schedule, the 2nd edition(ADOS-2)","The toddlers diagnosed with ASD will receive the ADOS-2 evaluation to confirm the diagnosis.",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Griffiths Developmental Scales, Chinese edition(GDS-C)","The toddlers diagnosed with ASD, GDD, LD, and typically developing will receive the GDS-C evaluation to confirm the diagnosis.",[9,16,20,24],[38],{"name":39,"affiliation":5,"role":40},"Xiu Xu","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Bingrui Zhou","CONTACT","13701989113","zbr1800@163.com",[48,64,77,90,103,117,130,139,152,160],{"facility":49,"status":10,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Hefei First People's Hospital","Hefei","Anhui","230061","China","CN",{"type":56,"coordinates":57},"Point",[58,59],117.28083,31.86389,{"lat":59,"lon":58},[62],{"name":63,"role":44,"phone":10,"phoneExt":10,"email":10},"Peiting Shen",{"facility":65,"status":10,"city":66,"state":67,"zip":68,"country":53,"countryCode":54,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Xiamen Children's Hospital","Xiamen","Fujian","361004",{"type":56,"coordinates":70},[71,72],118.08187,24.47979,{"lat":72,"lon":71},[75],{"name":76,"role":44,"phone":10,"phoneExt":10,"email":10},"Huiping Li",{"facility":78,"status":10,"city":79,"state":80,"zip":81,"country":53,"countryCode":54,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Liuzhou Maternity and child Healthcare Hospital","Liuzhou","Guangxi","545001",{"type":56,"coordinates":83},[84,85],109.40698,24.32405,{"lat":85,"lon":84},[88],{"name":89,"role":44,"phone":10,"phoneExt":10,"email":10},"Aiwen Li",{"facility":91,"status":10,"city":92,"state":93,"zip":94,"country":53,"countryCode":54,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"The Sixth Affiliated Hospital of Harbin Medical University","Harbin","Helongjiang","150023",{"type":56,"coordinates":96},[97,98],126.65,45.75,{"lat":98,"lon":97},[101],{"name":102,"role":44,"phone":10,"phoneExt":10,"email":10},"Lijie Wu",{"facility":104,"status":10,"city":105,"state":106,"zip":107,"country":53,"countryCode":54,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Kunshan Maternal and Child Health Care Hospital","Kunshan","Jiangsu","215300",{"type":56,"coordinates":109},[110,111],120.95431,31.37762,{"lat":111,"lon":110},[114],{"name":115,"role":44,"phone":116,"phoneExt":10,"email":10},"Qinyi Zhang","15950187911",{"facility":118,"status":10,"city":119,"state":120,"zip":121,"country":53,"countryCode":54,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Xi'an Children's Hospital","Xi'an","Shaanxi","710082",{"type":56,"coordinates":123},[124,125],108.92861,34.25833,{"lat":125,"lon":124},[128],{"name":129,"role":44,"phone":10,"phoneExt":10,"email":10},"Chunyang Li",{"facility":5,"status":10,"city":131,"state":132,"zip":133,"country":53,"countryCode":54,"cosmosGeoPoint":134,"geoPoint":138,"contacts":10},"Shanghai","Shanghai Municipality","201102",{"type":56,"coordinates":135},[136,137],121.45806,31.22222,{"lat":137,"lon":136},{"facility":140,"status":10,"city":141,"state":142,"zip":143,"country":53,"countryCode":54,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Chengdu Women's and Children's Central Hospital","Chengdu","Sichuan","610073",{"type":56,"coordinates":145},[146,147],104.06667,30.66667,{"lat":147,"lon":146},[150],{"name":151,"role":44,"phone":10,"phoneExt":10,"email":10},"Lan Zhang",{"facility":153,"status":10,"city":154,"state":155,"zip":156,"country":53,"countryCode":54,"cosmosGeoPoint":10,"geoPoint":10,"contacts":157},"Dehong People's Hospital","Dehong","Yunnan","678499",[158],{"name":159,"role":44,"phone":10,"phoneExt":10,"email":10},"Xueyan Li",{"facility":161,"status":10,"city":162,"state":163,"zip":164,"country":53,"countryCode":54,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Ningbo Women and Children's Hospital","Ningbo","Zhejiang","315012",{"type":56,"coordinates":166},[167,168],121.54945,29.87819,{"lat":168,"lon":167},[171],{"name":172,"role":44,"phone":10,"phoneExt":10,"email":10},"Lanqiu Lv",{"type":174,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[176,179,181,182,184,185,186,188,191,192],{"name":177,"class":178},"Harbin Institute of Technology, Shenzhen","UNKNOWN",{"name":180,"class":6},"Kunshan City Maternal and Child Health",{"name":49,"class":178},{"name":183,"class":6},"Ningbo Women & Children's Hospital",{"name":65,"class":6},{"name":140,"class":6},{"name":187,"class":6},"Liuzhou Maternity and Child Healthcare Hospital",{"name":189,"class":190},"Xian Children's Hospital","OTHER_GOV",{"name":153,"class":178},{"name":91,"class":178},"100593477","multicenter-validation-study-on-autism-screening-using-a-machine-assisted-system-100593477",false,"NCT07006948","Multicenter Validation Study on Autism Screening Using a Machine-assisted System","Multicenter Validation Study on the Effectiveness of a Machine-Assisted System for Early Screening of Autism","ASD group：\n\nInclusion Criteria:\n\n1. Children diagnosed with ASD according to a clinical judgement based on the criteria of ASD in DSM-5 and further confirmed with ADOS-2;\n2. Ages 1.5-2.5 years;\n3. Parents\u002Fcaregivers understand the content of the study and agree to participate in.\n\nGDD group：\n\nInclusion Criteria:\n\n1. Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000g;\n2. Clinically diagnosed with GDD (Global Developmental Delay) according to the DSM-V diagnostic criteria, with a Griffiths Development Scales-Chinese edition(GDS-C) assessment showing a Developmental Quotient (DQ) ≤75 in two or more domains;\n3. Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) using M-CHAT-R\u002FF.\n\nLD group：\n\nInclusion Criteria:\n\n1. Age 1.5-2.5 years, gestational age 37-42 weeks, birth weight 2500-4000 g;\n2. Clinically diagnosed with LD (Language Disorder) according to the DSM-V diagnostic criteria, with a Developmental Quotient (DQ) ≤75 in the language domain of the Griffiths Development Scales-Chinese edition(GDS-C) and DQ \\>75 in all other domains;\n3. Those who did not meet the initial screening positivity criteria for ASD (Autism Spectrum Disorder) assessed by M-CHAT-R\u002FF\n\nExclusion Criteria for ASD, GDD, and LD groups:\n\n1. Rett Syndrome, Fragile X Syndrome, Angelman Syndrome, Prader-Willi Syndrome, tuberous sclerosis, and other syndromes caused by known genetic defects or inherited metabolic diseases;\n2. Children with brain injuries, specific chronic or congenital diseases.\n3. The gestational age is less than 37 weeks, or the birth weight is lower than 2500g.\n\nTD group：\n\nInclusion Criteria:\n\n1. Healthy, typically developing toddlers aged 1.5-2.5 years ;\n2. gestational age of 37-42 weeks, birth weight of 2500-4000 g;\n3. Developmental Quotients(DQs) are greater than 75 in all domains of theGriffiths Development Scales-Chinese edition(GDS-C);\n4. Screened negative by M-CHAT-R\u002FF screening for autism spectrum disorder (ASD).\n\nExclusion Criteria:\n\nChildren with neurodevelopmental disorders (e.g., developmental delay, language impairment), neurological conditions (e.g., epilepsy, tuberous sclerosis), or other severe chronic diseases were excluded.",true,"ALL","18 Months","30 Months",{"count":205,"type":206},1000,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this observational study is to assess the effectiveness of a machine-assisted system for early screening of autism. The main questions it aims to answer are:\n\n* Does the machine-assisted system including 5 main behavioral paradigms identify toddlers with autism from those with other neurodevelopmental disorders and typical development?\n* Are there any differences in the early symptoms of autism among toddlers over the whole mainland China? Participants will receive some developmental and social communicational evaluations for clinical diagnoses. They will also receive the behavior evaluations of the machine-assisted system. The above evaluations will be performed just once.",[211,212,213],"Autism Spectrum Disorder","Early Developmental Impairment","Language Development Disorders","NOT_YET_RECRUITING","2025-09-15",{"date":217,"type":218},"2025-09-16","ACTUAL",{"date":215,"type":206},{"date":221,"type":206},"2029-06-15",{"name":5,"class":6},10]