[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603122":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":78,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Kansas Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Talk With Me Baby Clinics","EXPERIMENTAL","In TWMB clinics, TWMB will be delivered within usual WCC workflows for anticipatory guidance during the clinical encounter. TWMB is delivered by the primary clinician (i.e., pediatrician\u002Ffamily medicine physician; physician assistant; nurse practitioner) and\u002For a clinician and care team. TWMB targets key evidence-based language promotion strategies that previous research has shown to improve child language outcomes. TWMB training involves didactic and practice-based instruction (CME\u002FCNE) that includes: (a) a brief review of the science behind why language promotion matters; (b) focused instruction (with video examples and modeling) on how to deliver components of TWMB, including the TWMB Checklist and Language Nutrition Prescription; and (c) live practice and role play with the trainer on delivering TWMB across child ages and families.",[13],"Behavioral: Patients in Talk With Me Baby Clinics",{"label":15,"type":16,"description":17,"interventionNames":18},"Care-As-Usual Clinics","ACTIVE_COMPARATOR","Providers\u002Fcare teams will deliver care-as-usual WCC visits for all children. Parent-child participants in Control clinics will receive WCC anticipatory guidance care as usual. No treatment control is in line with the literature on randomized behavioral\u002Feducational interventions.",[19],"Behavioral: Patients in Care-As-Usual Clinics",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Patients in Talk With Me Baby Clinics","Parent-child participants in TWMB clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Patients in Care-As-Usual Clinics","Parent-child participants in Care-As-Usual clinics will attend their regular WCC visits (scheduled per routine clinic processes) following the AAP Periodicity Schedule. Measures will be completed at five time points.",[15],[32],{"name":33,"affiliation":5,"role":34},"Brenda J Salley, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","913-945-7944","bsalley@kumc.edu",[41,61],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Emory University","NOT_YET_RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-84.38798,33.749,{"lat":53,"lon":52},[56,60],{"name":57,"role":37,"phone":58,"phoneExt":26,"email":59},"Susan N Brasher, PhD, RN, CPNP, FAAN","404-727-6490","susan.n.brasher@emory.edu",{"name":57,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":5,"status":62,"city":63,"state":64,"zip":65,"country":47,"countryCode":48,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"RECRUITING","Kansas City","Kansas","66160",{"type":50,"coordinates":67},[68,69],-94.62746,39.11417,{"lat":69,"lon":68},[72,73,77],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":74,"role":37,"phone":75,"phoneExt":26,"email":76},"Megan Olalde, MS, RD, CCRP","913-588-2042","molalde@kumc.edu",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":79,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[81],{"name":82,"class":83},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100603122","talk-with-me-baby-leveraging-well-child-care-to-enhance-the-early-home-language-environment-100603122",false,"NCT07132411","Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment","TWMB","Inclusion Criteria for Participants:\n\n* Child must be enrolled prior to attending their 2-month WCC visit, age 1 month (+\u002F- 30 days)\n* Full term (\\>=37 weeks gestation)\n* Singleton birth\n* Home language of English and\u002For Spanish\n* Child must receive WCC at a participating clinic\n\nExclusion Criteria for Participants:\n\n* Child with a severe congenital disorder that would affect neurodevelopmental outcomes, or hearing impairment that could affect participation\n* Parent does not live with or spend \\>=2 days\u002Fweek with the child\n* Family does not plan to continue services at the clinic\n\nInclusion Criteria for Clinics:\n\n* A primary care practice (family medicine or pediatric model) that delivers WCC for children from 0-36 months old\n* A minimum of 30% Medicaid\u002Funinsured visits\u002Fyear\n* A minimum of 300 unique 0 to 36-month-old patients\u002Fyear","ALL","1 Day","2 Years",{"count":95,"type":96},400,"ESTIMATED","INTERVENTIONAL",[99],"NA","Language-rich interactions with a parent or caregiver can serve as a protective factor for young children, by supporting their language development and other positive long-term outcomes, but existing interventions have not had the necessary reach to families who need this information the most. This study utilizes the primary care setting as a low cost, scalable way to deliver language promotion intervention. Specifically, we will test the effectiveness and explore implementation of language promotion intervention (Talk With Me Baby) that embeds within anticipatory guidance during pediatric well-child care to boost early language development and optimize health, academic, and economic outcomes.",[102,103,104],"Child Language","Language Delay","Developmental Milestones",[106,107,108,109,110,111],"well-child care","primary care practices","home language environment","preventative intervention","language development","language promotion intervention","2026-03-20",{"date":114,"type":115},"2026-03-24","ACTUAL",{"date":117,"type":115},"2026-02-05",{"date":119,"type":96},"2029-06",{"name":5,"class":6},2]