[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639392":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":47,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":30,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":30,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":76,"whyStopped":30,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Emory University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Families with children enrolled in BCW with suspected diagnosis of autism","EXPERIMENTAL","Post-consent, families with children between 16-33 months will receive a link to complete the EAC Developmental History Survey on REDCap and a link to complete parent\u002Fcaregiver questionnaires about developmental and\u002For adaptive information. Children will be assessed via a remote telehealth session with an EAC clinician, using age-appropriate standardized measures. Clinicians rate confidence after four points: intake review, parent interview and child observation, child assessment, and DSM-5-TR checklist completion. Feedback is provided via telehealth, and a final report with recommendations is issued. Psychologists will be asked about the protocol after each assessment. Parents\u002Fcaregivers will be asked to answer questions during the assessment, immediately after the assessment, and 3 months later. EI providers will also be asked questions about their experience after the assessment. Total length of enrollment range 3-16 weeks.",[13],"Behavioral: Early Diagnostic Response Model Expanded",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Early Diagnostic Response Model Expanded","A telehealth diagnostic protocol for assessing toddlers identified as moderate- or high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program. This pilot will evaluate how many of the initial assessments can be completed entirely via a streamlined telehealth protocol and the level of diagnostic confidence achieved.",[9],[21],"EDRM-E",[23],{"name":24,"affiliation":5,"role":25},"Allison J Schwartz, PhD","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","404-727-6865",null,"allison.schwartz@emory.edu",[33],{"facility":5,"status":30,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Atlanta","Georgia","30322","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-84.38798,33.749,{"lat":43,"lon":42},[46],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"type":25,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Allison Schwartz","Assistant Professor",[51],{"name":52,"class":53},"Georgia Department of Public Health","UNKNOWN","100639392","early-diagnostic-telehealth-pilot-for-moderate--and-high-risk-children-evaluating-assessment-protocols-and-efficiency-in-georgias-early-intervention-program-100639392",false,"NCT07623759","Early Diagnostic Telehealth Pilot for Moderate- and High-Risk Children: Evaluating Assessment Protocols and Efficiency in Georgia's Early Intervention Program","Early Diagnostic Telehealth Pilot for Moderate- and High-risk Children: Evaluating Protocols for Children in Georgia's Early Intervention Program","Inclusion Criteria:\n\n* Child is enrolled in a participating BCW district.\n* Child is 16-36 months of age at the time of referral.\n* Child is identified as moderate- or high-risk on the M-CHAT-R\u002FF\n* BCW provider submits a referral to the EDRM-E pilot by 33 months of age.\n* Parent\u002Fguardian has basic English proficiency in order to complete intake forms and in-depth interview, and the child has exposure to English at home or in out-of-home care.\n* Documentation of the M-CHAT-R\u002FF screening results and parental consent to refer is completed and submitted.\n\nExclusion Criteria:\n\n* Families making self-referrals to the EAC or referred from non-onboarded BCW districts.\n* Child is older than 33 months at referral.\n* Non-English speaking families due to staffing and resource limitations as the consent, parent interview and child assessment would need to be done and accessible in other languages and are not available within this study scope at this time. .","ALL","16 Months","36 Months",{"count":65,"type":66},100,"ESTIMATED","INTERVENTIONAL",[69],"NA","This pilot study includes children identified as moderate- as well as high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program. The project will evaluate the feasibility, acceptability, and implementation of a diagnostic protocol, including optional measures, through measures of recruitment, retention, adherence, provider confidence, and time from referral to report completion. It will also examine which child diagnostic measures are essential and needed to improve psychologists' diagnostic confidence. Caregiver, early intervention provider, and clinician experiences and satisfaction before, during, and after assessment will be assessed to evaluate protocol acceptability, knowledge, and access to services. Outcomes will be analyzed using the RE-AIM Framework (reach, effectiveness, adoption, implementation, maintenance) and compared across BCW districts and child characteristics, including changes in autism screening, referral, and evaluation rates over time.",[72,73],"Autism Spectrum Disorder","Autism",[73,75],"Early Intervention","NOT_YET_RECRUITING","2026-05-29",{"date":79,"type":80},"2026-06-03","ACTUAL",{"date":82,"type":66},"2026-06",{"date":84,"type":66},"2027-06",{"name":5,"class":6},1]