An observational study in Cleft Lip and Palate and Speech Disorders in Children, sponsored by University Ghent. Recruiting at 1 site in Belgium. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by University Ghent · Observational
A cleft (lip and) palate (CP±L) is the most common congenital abnormality of the face and skull with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with CP±L based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with CP±L and their caregivers). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological/audiological data will be collected from the medical records of the children with CP±L. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 175 is above the median of 100 across 49 observational studies indexed under Cleft Lip.
Browse Cleft Lip studies →University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.
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The population are children born with a cleft palate (with or without a cleft lip). They are 4 to 12 years old and have at least one compensatory speech error in their speech.
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Exclusion Criteria:
High intensity speech intervention 5 times 30' per week for 2 times 4 weeks
low intensity speech intervention 2 times 30' per week for 20 weeks
Perceptions and acceptability of low/high intensive speech intervention
Participants will be interviewed and can talk about their experiences and perceptions regarding the speech intervention intensity. The acceptability of both high and low intensive therapy will be examined
Time frame: 20 weeks
Plan to share: No
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