[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508525":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"STAR intervention group","EXPERIMENTAL","The intervention strategies in STAR model are designed under the Naturalistic Developmental Behavioral Intervention (NDBI) framework which are implemented in natural settings targeting at improving social and communicational capabilities. The structure of the STAR model is with 2 modules and 16 sessions. Module I derives from our previous offline parent-tutoring courses with 8 intervention strategy topics combining academic instruction and real child demonstration but modified into on-line version. Module II is designed specifically for long-term consolidation of parents' intervention skills containing 8 biweekly sessions of distance coaching with parents practicing intervention with their children in real time at home.",[13],"Behavioral: Strategies for Toddler ASD with Remote-therapy (STAR)",{"label":15,"type":6,"description":16,"interventionNames":17},"community intervention group","This group will have community interventions parents can choose.",[18],"Behavioral: Community intervention",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Strategies for Toddler ASD with Remote-therapy (STAR)","The intervention strategies in STAR model are designed under the Naturalistic Developmental Behavioral Intervention (NDBI) framework which are implemented in natural settings targeting at improving social and communicational capabilities",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Community intervention","Regular community intervention",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Qiong Xu, PhD","CONTACT","02164931275","xuqiong@fuda.edu.cn",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Chunchun Hu, MD","15721445658","14211240007@fudan.edu.cn",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Shanghai","Shanghai Municipality","201102","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},[55],{"name":32,"role":33,"phone":25,"phoneExt":25,"email":56},"stellaxuqiong@hotmail.com",{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100508525","strategies-for-toddler-asd-with-remote-therapy-star-model-for-asd-100508525",false,"NCT05901558","Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD","Strategies for Toddler ASD With Remote-therapy (STAR) Model for Early ASD Toddlers: a Randomized Trial","Inclusion Criteria:\n\n* Children screened as positive for ASD.\n* Two-tiered screening process combing Level 1(The Modified Checklist for Autism in Toddlers-Revised\u002FFollow-Up , M-CHAT-R\u002FF) and Level 2 (The Screening Tool for Autism in Toddlers and Young Children, STAT)\n\nExclusion Criteria:\n\n* Other neurologic or degenerative diseases;\n* Severe hearing or visual impairment;\n* Genetic anomaly which may affect impact on intervention;\n* Not available for regular intervention and follow-up.","ALL","16 Months","30 Months",{"count":70,"type":71},110,"ESTIMATED","INTERVENTIONAL",[74],"NA","The project aims to develop and implement the Strategies for Toddler Autism spectrum disorder(ASD) with Remote-therapy (STAR) model for early toddlers with ASD in local community sites in Shanghai. It's a randomized control trial lasting 3 years. The children will be divided into 2 groups, one for STAR intervention group and the other for community intervention group. The STAR intervention group will be performed STAR other than community intervention.",[77,78],"Autism Spectrum Disorder","Therapy",[80,81,82],"Autism","Naturalistic developmental behavioral intervetion","Intervention","2025-09-03",{"date":85,"type":86},"2025-09-05","ACTUAL",{"date":88,"type":86},"2023-06-15",{"date":90,"type":71},"2026-12-30",{"name":5,"class":6},1]