[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527091":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":69,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":24,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Symbolic Gesture Training Group","EXPERIMENTAL","Caregivers of children who are assigned to the SGT group will participate in three caregiver training meetings to learn how to use infant signing in combination with verbal training to promote the speech and language development of their child. These meetings will take place 1 month (meeting 1), 2 months (meeting 2) and 3 months (meeting 3) after baseline assessments are performed (T0). Each meeting will take two hours. After the first training session (meeting 1), caregivers will start using the symbolic gestures to support verbal in- and output at home with their child.",[13],"Behavioral: Infant sign training",{"label":15,"type":16,"description":17,"interventionNames":18},"Verbal Training Group","ACTIVE_COMPARATOR","Caregivers of children who are assigned to the VT group will participate in three caregiver training meetings to learn how to use verbal training to promote the speech and language development of their child. These meetings will take place 1 month (meeting 1), 2 months (meeting 2) and 3 months (meeting 3) after baseline assessments are performed (T0). Each meeting will take two hours. After the first training session (meeting 1), caregivers will start using supporting verbal in- and output at home with their child.",[19],"Behavioral: Verbal training",{"label":21,"type":22,"description":23,"interventionNames":24},"No Intervention Control Group","NO_INTERVENTION","Standard clinical care at this moment at the Cleft Palate Teams of the University Hospitals of Ghent and Leuven includes providing information to caregivers about speech-language development and encouraging caregivers to communicate with their children. This information will be orally provided by an SLP during a standard clinical appointment at the cleft team at the age of 12 months. A brochure including this information will be provided. Caregivers of children who will be assigned to group C will have the opportunity to receive the most effective intervention (SGT or VT) after finishing the study.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"BEHAVIORAL","Infant sign training","Training session 1: Information is given about what infant signs are, how they originated, how speech and (gestural) language develop in young children with CP ± L, the possible advantages of using infant signs and tips for success. Twelve signs are chosen to start with: six narrative signs (mostly object concepts) and six steering signs (mostly non-object concepts). Training session 2: Experiences with using infant signs at home are shared, repetition of the 12 infant signs and tips for success are discussed. Another 12 signs are chosen to add to the repertoire the caregivers can use, based on caregiver input. Training session 3: The same as training session 2. The content is based on the input the caregivers experience. Another 12 signs are chosen to add to the repertoire the caregivers can use, based on caregiver input. Reading aloud while using infant signs is shown and practiced.",[9],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Verbal training","Training session 1: Information is given about how speech and language develop in young children with CP ± L and how caregivers can support their child during this development Tips for success and suggestions on how to use these supportive verbal techniques at home are discussed. Training session 2: Experiences with using supportive verbal techniques at home are shared and supportive verbal techniques repeated. Information is provided about how children learn new words and tips for success are expanded. Training session 3: The same as training session 2. The content is based on the input the caregivers experience. Additionally, advances of reading aloud are discussed and reading aloud is practiced.",[15],[36],{"name":37,"affiliation":5,"role":38},"Kristiane Van Lierde, PhD","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":24,"email":44},"Kim Bettens, PhD","CONTACT","+32 9 332 94 26","Kim.Bettens@UGent.be",{"name":37,"role":42,"phone":46,"phoneExt":24,"email":47},"+32 9 332 23 91","Kristiane.Vanlierde@UGent.be",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Ghent University Hospital","RECRUITING","Ghent","East Flanders","9000","Belgium","BE",{"type":58,"coordinates":59},"Point",[60,61],3.71667,51.05,{"lat":61,"lon":60},[64,65,66,68],{"name":41,"role":42,"phone":43,"phoneExt":24,"email":44},{"name":37,"role":42,"phone":46,"phoneExt":24,"email":47},{"name":41,"role":67,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"name":37,"role":38,"phone":24,"phoneExt":24,"email":24},{"type":70,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[72],{"name":73,"class":6},"University Ghent","100527091","effect-of-infant-sign-training-on-speech-language-development-100527091",false,"NCT06143254","Effect of Infant Sign Training on Speech-language Development","The Effect of Using Symbolic Gestures on the Speech and Language Development in Prelinguistic Children Born With Cleft Palate","Inclusion Criteria:\n\n* Born with cleft palate (with or without cleft lip)\n* Having Dutch as mother tongue\n\nExclusion Criteria:\n\n* syndromic cleft\n* more than mild hearing loss (i.e. \\> 40dB hearing threshold bilaterally)\n* neurosensory hearing loss\n* cognitive delay\n* motor delay","ALL","12 Months","24 Months",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89],"NA","Children born with a cleft lip and palate (CLP) are known to be at risk for speech-language disorders that impact academic and social emotional growth. Even at very young ages (\\\u003C3 years), speech-language disorders are already observed. It is hypothesized that speech-language intervention delivered before the age of 3 years old could decrease the impact of CLP on speech-language development. This would result in a decreased need for speech-language therapy on the long-term and a reduced burden of care on children, families and health services. However, no evidence is yet available to support any specific model of early speech-language intervention in this population. Consequently, no standardized clinical practice guidelines are available yet. Symbolic gesture training in combination with verbal input expands the natural communication of young children including multimodal speech-language input (i.e., verbal and manual input) via caregivers who act as co-therapists. To contribute to the evidence-based practice in the field of cleft speech therapy, this research project aims to determine the effectiveness and feasibility of symbolic gesture training in one-year old children with CLP by comparing different intervention approaches based on perceptual, psychosocial and qualitative outcome measures.",[92],"Cleft Palate Children",[94,95,96,97],"cleft palate","gesture","speech and language development","therapy","2024-01-29",{"date":100,"type":101},"2024-01-30","ACTUAL",{"date":103,"type":101},"2023-11-09",{"date":105,"type":86},"2027-10-30",{"name":5,"class":6},1]