[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431550":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":37,"locations":45,"responsibleParty":66,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":23,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":48,"whyStopped":23,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)","EXPERIMENTAL","A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.",[13],"Behavioral: Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)",{"label":15,"type":10,"description":16,"interventionNames":17},"Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H)","A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.",[18],"Behavioral: Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)",{"label":20,"type":21,"description":22,"interventionNames":23},"Treatment As Usual (TAU)","NO_INTERVENTION","This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase.",null,[25,29],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":23},"BEHAVIORAL","Pivotal Response Treatment in autism center.",[9],{"type":26,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)","Pivotal Response Treatment in home environment.",[15],[34],{"name":35,"affiliation":5,"role":36},"Antonio Y. Hardan, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":23,"email":42},"Maddy Clark","CONTACT","(650)736-1235","PALprogram@stanford.edu",{"name":44,"role":40,"phone":41,"phoneExt":23,"email":42},"Beatrice Begley",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Stanford University School of Medicine","RECRUITING","Stanford","California","94305","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.16608,37.42411,{"lat":58,"lon":57},[61,63,64],{"name":39,"role":40,"phone":62,"phoneExt":23,"email":42},"(650) 736-1235",{"name":44,"role":40,"phone":62,"phoneExt":23,"email":42},{"name":65,"role":36,"phone":23,"phoneExt":23,"email":23},"Antonio Y Hardan, MD",{"type":36,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Antonio Hardan","Professor",[70],{"name":71,"class":72},"Anonymous Donor","UNKNOWN","100431550","trial-of-center-based-vs-in-home-pivotal-response-treatment-prt-in-autism-100431550",false,"NCT04899544","Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","Randomized Controlled Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism","PRT-HvC","Inclusion Criteria:\n\n* Diagnosis of Autism Spectrum Disorder (ASD) based on Autism Diagnostic Interview Revised (ADI-R), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) or Childhood Autism Rating Scale, Second Edition (CARS-2), Diagnostic and Statistical Manual 5th Edition (DSM-5), and expert clinical opinion;\n* Boys and girls between 2.0 and 5.11 years;\n* Ability to participate in the testing procedures to the extent that valid standard scores can be obtained;\n* Language delay as measured by the Preschool Language Scale, 5th Edition (PLS-5): Standard score at least 1 standard deviation below average for expressive language ability for 2 and 3 year olds; 2 standard deviations for 4 year olds, and 3 standard deviations for 5 year olds;\n* Stable treatment (e.g., Applied Behavior Analysis - ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements;\n* No anticipated changes on treatment during study participation for Center-Based Pivotal Response Treatment (PRT-C) and In-Home Pivotal Response Treatment (PRT-H);\n* No more than 60 minutes of individual 1:1 speech therapy per week;\n* Availability of at least one parent or primary caregiver who can consistently participate in parent training and research measures.\n\nExclusion Criteria:\n\n* Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder, etc.);\n* Receiving ABA of 15 hours or more;\n* Presence of active medical problem (e.g., unstable seizure disorder or heart disease);\n* Previous adequate Pivotal Response Treatment (PRT) trial;\n* Participants living more than 30 miles from Stanford University;\n* Child's primary language other than English.","ALL","2 Years","5 Years",{"count":85,"type":86},120,"ESTIMATED","INTERVENTIONAL",[89],"NA","The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).",[92,93,94],"Autism","Autism Spectrum Disorder","ASD",[96,97,98,99],"pivotal response treatment","PRT","center based","social and communication","2026-06-22",{"date":102,"type":103},"2026-06-24","ACTUAL",{"date":105,"type":103},"2022-10-18",{"date":107,"type":86},"2028-09-15",{"name":5,"class":6},1]