[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513199":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":54,"collaborators":56,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":11,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":11},"Non-treatment Model Building","NO_INTERVENTION",null,{"label":13,"type":14,"description":15,"interventionNames":16},"Communication Treatment","EXPERIMENTAL","Terminated",[17],"Behavioral: Parent-Implemented Communication Treatment",[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"BEHAVIORAL","Parent-Implemented Communication Treatment","The intervention will be taught by a qualified professional online and\u002For in-person for about 6 months. Parents will learn strategies to enhance their children's social communication and will receive coaching and feedback.",[13],[25],{"name":26,"affiliation":5,"role":27},"Nancy M Young, MD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":11,"email":32},"CONTACT","312-227-6812","nyoung@luriechildrens.org",{"name":34,"role":30,"phone":11,"phoneExt":11,"email":35},"Emily (Shimeng) Xu, PhD","sxu@luriechildrens.org",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Ann & Robert H. Lurie Children's Hospital of Chicago","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-87.65005,41.85003,{"lat":49,"lon":48},[52],{"name":53,"role":30,"phone":11,"phoneExt":11,"email":32},"Nancy Young, MD",{"type":27,"investigatorFullName":53,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Head, Section of Otology\u002FNeurotology and Medical Director, Audiology & Cochlear Implant Programs",[57,59,61,63,65,67],{"name":58,"class":6},"Chinese University of Hong Kong",{"name":60,"class":6},"Northwestern University",{"name":62,"class":6},"University of North Carolina, Chapel Hill",{"name":64,"class":6},"University of Southern California",{"name":66,"class":6},"University of Miami",{"name":68,"class":6},"The University of Texas at Dallas","100513199","neural-prediction-to-enhance-language-100513199",false,"NCT05962359","Neural Prediction to Enhance Language","Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant","Inclusion Criteria (Arm 1):\n\n1. Children with sensorineural hearing loss who meet clinical criteria for cochlear implantation in both ears who meet the following age criteria at time cochlear implant evaluation begins:\n\n   * Age 5 years and under.\n   * English or Spanish as the dominant language.\n2. English or Spanish dominant language in the home.\n\nInclusion Criteria (Arm 2):\n\n1. Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation\n2. English dominant spoken language by family\n3. Age at implantation of 36 months and younger when treatment begins\n4. Parent or caregiver that is willing to participate who understands spoken English\n5. Child is exposed to spoken language by at least one parent (total communication or auditory\u002Foral) in the home\n\nExclusion Criteria (Arm 1):\n\n1. Severe motor and \u002For cognitive disability that would preclude evaluation of progress\n2. Limited electrode insertion likely to significantly impact development of speech perception\n3. Hearing loss due to bacterial meningitis\n4. Neither English or Spanish as the dominant family language in the home\n\nExclusion Criteria (Arm 2):\n\n1. Severe motor and \u002For cognitive disability that would preclude evaluation of progress\n2. Limited electrode insertion likely to significantly impact development of speech perception\n3. Hearing loss due to bacterial meningitis\n4. Dominant language other than English\n5. Diagnoses or medical conditions expected to impact language development independent of hearing loss\n6. Cochlear nerve deficiency in implanted ears or severe cochlear malformation\n7. Children already having spoken language who score better than 25th percentile on the Words and Sentences portion of the CDI language evaluation.\n8. Child with more than two months CI experience prior to start of treatment","ALL","0 Months","5 Years",{"count":80,"type":81},700,"ESTIMATED","INTERVENTIONAL",[84],"NA","The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the individual child level. The long-term goal is improving children's language by using predictive models to enable a custom \"predict to prescribe\" approach to intervene with more effective behavioral therapy for children at risk to develop poorer language. The investigators previously developed models for short term language outcome of English-learning implanted children. The aims of this study are to 1. Develop models able to predict long term outcome for English- learning and Spanish-learning children; and 2. To evaluate whether English-learning children predicted to achieve lower language based on the investigators' previously constructed models can demonstrate significant gains from Parent Implemented Communication Treatment (PICT). PICT is an intensive parent education program about strategies to improve children's communication.",[87,88,89],"Bilateral Sensorineural Hearing Loss","Speech and Language Development Delay Due to Hearing Loss","Social Communication",[91,92,93,94],"Hearing Loss","Children","Parent-mediated intervention","Language prediction","2026-06-30",{"date":97,"type":98},"2026-07-02","ACTUAL",{"date":100,"type":98},"2023-01-23",{"date":102,"type":81},"2028-01-23",{"name":5,"class":6},1]