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
N/A
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/or palate (CP±L) is a common birth condition affecting the face and skull, impacting speech, hearing, feeding, oral behavior, teeth, and appearance. These effects can harm social integration and well-being over time. The World Health Organization highlights the financial and emotional burdens on patients, families, and society. This study compares high- and low-intensity speech therapy for children with CP±L, focusing on the views of speech therapists and families to understand their experiences and acceptability. The study evaluates two speech therapy approaches: a high-intensity combined phonetic-phonological intervention given five times a week for 30 minutes over two 4-week periods, and a low-intensity intervention given twice weekly for 30 minutes over 20 weeks. Interviews with therapists and children plus caregivers will explore their perceptions of these interventions. The study may adjust the high-intensity therapy based on feedback to improve its use in clinical practice. Participants will take part in recorded interviews at convenient times and complete demographic questionnaires. Medical data on the cleft type, surgery history, and ear/hearing status will be reviewed. The study measures the perceptions and acceptability of the two therapy intensities over 20 weeks. This information aims to support better implementation of high-intensity speech therapy and improve outcomes for children with CP±L.
CONDITIONS
Brief 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 in their speech based on the perceptual assessment of one experienced speech-language pathologist
You will not qualify if you...
- Children with syndromic clefts
- Oronasal fistula
- Velopharyngeal insufficiency
- Hearing disabilities based on pure tone audiometry (>25 dB HL)
- Cognitive and/or related learning disabilities or neuromuscular disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants receive speech interventions of varying intensity according to their assigned group.
Weekly visits for up to 20 weeks
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
Research Team
T
Tara Mouton
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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