[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481647":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":50,"collaborators":52,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":18,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","12, 1-hour ESDM-informed caregiver coaching sessions, delivered by non-specialists. Intervention materials and approach have been adapted for the South African context.",[13],"Behavioral: ESDM-informed caregiver coaching",{"label":15,"type":16,"description":17,"interventionNames":18},"Delayed intervention control group","NO_INTERVENTION","Usual care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","ESDM-informed caregiver coaching","The coaching intervention is informed by the Community-Early Start Denver Model (C-ESDM). The intervention has been adapted for the South African context. Training procedures have been adapted for delivery by non-specialist coaches. Twelve session-specific visuals with simple-text (for caregivers) and session scripts (for non-specialist coaches) have been developed. Over 12, 1-hour caregiver coaching sessions that are delivered by non-specialists, caregivers are coached in strategies to increase child attention to their social world, increase child communication, create and build joint activity routines, and understand and use the ABCs to support the development of new behaviors.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Lauren Franz, MBChB","CONTACT","+1919 681-0023","lauren.franz@duke.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University of Cape Town","RECRUITING","Cape Town","West Cape","South Africa","ZA",{"type":40,"coordinates":41},"Point",[42,43],18.42322,-33.92584,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":48,"phoneExt":18,"email":49},"Petrus de Vries","+27 (0) 21 685 4103","petrus.devries@uct.ac.za",{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[53],{"name":33,"class":6},"100481647","autism-caregiver-coaching-in-africa-100481647",false,"NCT05551728","Autism Caregiver Coaching in Africa","ACACIA","Inclusion Criteria:\n\n* Child's age is 18-72 months\n* Child meets DSM-5 criteria for autism spectrum disorder (ASD), informed by Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)\n* Child's caregiver speaks isiXhosa, isiZulu, Afrikaans, or English\n* Child's race is African or Coloured (South African term for mixed race)\n* Caregiver-child dyad live in recruitment area\n* Caregiver is ≥18 years\n\nExclusion Criteria:\n\n* Genetic disorder of known etiology (e.g., fragile X syndrome)\n* Significant sensory or motor impairment that would preclude use of the play materials\n* Major physical abnormalities that would interfere with participation in the intervention\n* History of serious head injury and\u002For neurological disease\n* Caregiver indicates they will be unable to attend assessments and 12 sessions","ALL","18 Months","72 Months",{"count":65,"type":66},320,"ESTIMATED","INTERVENTIONAL",[69],"NA","Around the world there is a growing need to develop early intervention services in local communities that support a better quality of life for all autistic people. The South African study will test an approach where caregivers are coached by non-specialists in early intervention strategies. Caregivers can then use these strategies during everyday activities with their young autistic child.",[72],"Autism or Autistic Traits","2026-01-07",{"date":75,"type":76},"2026-01-09","ACTUAL",{"date":78,"type":76},"2023-04-01",{"date":80,"type":66},"2027-09",{"name":5,"class":6},1]