[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649801":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":74,"collaborators":18,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":18,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":99,"whyStopped":18,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Murdoch Childrens Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Babble Boot Camp","EXPERIMENTAL","Infants in the intervention group will be treated through collaboration between a speech pathologist and one (or both, if available) parent. The principles and goals of the intervention are related to the deficits commonly seen in infants born preterm, with individualised strategies to be used in the home to support prelinguistic speech and language skills.",[13],"Behavioral: Babble Boot Camp",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Infants enrolled in both groups will receive usual care in the community as it is unethical to withhold care. Typical services include routine medical care, social work support, physiotherapy, occupational, or speech therapy assessments, and referral to local early intervention programs as deemed necessary by the primary medical team.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","The intervention will be delivered by the following method:\n\nWeekly 15-minute telehealth sessions with topics around understanding and responding to infant behaviour, promoting development through enhanced parent child interaction and demonstrating intervention activities. Toys will be used to facilitate language development with parents coached on appropriate interactions. During these sessions, the therapist will coach the parent to deliver intervention activities with their infant during daily routines and activities. The parent will record 2-3 short videos of their child to be submitted to the therapist weekly prior to the telehealth session.",[9],[25],{"name":26,"affiliation":5,"role":27},"Angela T Morgan","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","+61383416458","angela.morgan@mcri.edu.au",{"name":34,"role":30,"phone":18,"phoneExt":18,"email":35},"Victoria A Heinlen","victoria.heinlen@mcri.edu.au",[37,61],{"facility":38,"status":18,"city":39,"state":40,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Murdoch Children's Research Institute","Melbourne","Victoria","Australia","AU",{"type":44,"coordinates":45},"Point",[46,47],144.96332,-37.814,{"lat":47,"lon":46},[50,52,53,54,57,59],{"name":51,"role":30,"phone":31,"phoneExt":18,"email":32},"Angela Morgan",{"name":34,"role":30,"phone":18,"phoneExt":18,"email":35},{"name":26,"role":27,"phone":18,"phoneExt":18,"email":18},{"name":55,"role":56,"phone":18,"phoneExt":18,"email":18},"Alicia Spittle","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":18,"phoneExt":18,"email":18},"Beate Peter",{"name":60,"role":56,"phone":18,"phoneExt":18,"email":18},"Victoria Heinlen",{"facility":62,"status":18,"city":39,"state":40,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"The Royal Women's Hospital",{"type":44,"coordinates":64},[46,47],{"lat":47,"lon":46},[67,69,70,71,72,73],{"name":55,"role":30,"phone":18,"phoneExt":18,"email":68},"aspittle@unimelb.edu.au",{"name":60,"role":30,"phone":18,"phoneExt":18,"email":35},{"name":55,"role":27,"phone":18,"phoneExt":18,"email":18},{"name":51,"role":56,"phone":18,"phoneExt":18,"email":18},{"name":58,"role":56,"phone":18,"phoneExt":18,"email":18},{"name":60,"role":56,"phone":18,"phoneExt":18,"email":18},{"type":75,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100649801","using-the-babble-boot-camp-speech-therapy-approach-with-babies-born-prematurely-100649801",false,"NCT07738224","Using the Babble Boot Camp© Speech Therapy Approach With Babies Born Prematurely","Babble Boot Camp© for Preterm Infants: A Trial of a Proactive Speech\u002FLanguage Intervention","BBCPrem","Inclusion Criteria:\n\n* Infants born \\\u003C32 weeks' gestational age (GA)\n* Infants medically stable and not ventilator dependent at recruitment\n* Primary language spoken at home is English\n* Participants able to attend 6 months of telehealth early intervention\n* Infants less than 5.5 months corrected age\n\nExclusion Criteria:\n\n* Diagnosis of a chromosomal or genetic anomaly known to affect development,\n* Significant hearing and vision loss\n* Clefting of the lip or palate\n* Hypoxic ischemic encephalopathy\n* Intraventricular haemorrhage grade 3 or 4\n* Participants participating in any other trials including BBC","ALL","6 Months",{"count":87,"type":88},86,"ESTIMATED","INTERVENTIONAL",[91],"NA","Babble Boot Camp focuses on early speech and language development, environmental enrichment and supporting parent-infant interaction with the aim of improving communication outcomes and parental well-being in at risk children.\n\nThe goal of this clinical trial is to learn if this parent-coaching speech therapy intervention delivered via telehealth helps to support babies born very preterm with their earliest stages of communication.\n\nThe main questions it aims to answer are:\n\nDoes Babble Boot Camp increase language outcomes in infants born very preterm? Is Babble Boot Camp able to be successfully completed by caregivers, and do caregivers believe Babble Boot Camp is possible to implement at home? What is the family impact of Babble Boot Camp?\n\nParticipants will:\n\nBe randomly assigned into either a \"treatment group\" or a \"usual care group.\" If allocated into the treatment group using Babble Boot Camp, participants will attend weekly 15-minute therapy sessions with a speech pathologist for 6 months.\n\nBoth groups (\"treatment group\" or a \"usual care group\") will complete questionaries at enrollment and when the child participant is 6, and 12 months old (corrected age).",[94],"Premature Infants",[96,97,98],"Early intervention","speech therapy","Caregiver-implemented","NOT_YET_RECRUITING","2026-08-17",{"date":102,"type":103},"2026-08-19","ACTUAL",{"date":105,"type":88},"2026-08",{"date":107,"type":88},"2028-08",{"name":5,"class":6},2]