Actively Recruiting
High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists
Led by University Ghent · Updated on 2025-03-26
175
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
U
University Ghent
Lead Sponsor
R
Research Foundation Flanders
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
- Aged between 4 and 12 years
- Presence of at least one compensatory speech error based on assessment by an experienced speech-language pathologist
You will not qualify if you...
- Children with syndromic clefts
- Presence of oronasal fistula
- Velopharyngeal insufficiency
- Hearing disabilities with hearing loss greater than 25 dB HL
- Cognitive, learning, or neuromuscular disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
T
Tara Mouton
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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