Comparing speech interventions for children with cleft palate
Official title: High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists
Run by University Hospital, Ghent · NCT06895395 · Data updated 2026-11-12
This study is trying to find out if high or low intensity speech therapy works better for children with cleft palate by talking to the kids, their caregivers, and speech therapists about their experiences.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 4 Years to 12 Years |
| Sex | All |
| Enrollment | 175 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | March 26, 2025 |
| Trial ID | NCT06895395 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Belgian Dutch-speaking children aged 4 to 12 years with a cleft palate and at least one compensatory speech error.
✕Probably not a fit
Children with syndromic clefts, oronasal fistula, velopharyngeal insufficiency, hearing disabilities, or cognitive and related learning disabilities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare high and low intensity speech interventions for children with cleft palate by gathering perceptions from both speech-language pathologists and the children and their caregivers. The study will involve individual semi-structured interviews to explore experiences and acceptability of the different intervention intensities. By focusing on qualitative feedback, the research seeks to understand the social and emotional impacts of these interventions on the participants. The findings could inform future speech therapy practices for children with cleft lip and palate.
Why it matters
Potential benefit: If successful, this study could enhance speech therapy approaches for children with cleft palate, leading to improved communication outcomes and quality of life.
How similar studies have gone: While this study explores a specific qualitative approach, similar interventions have shown promise in improving speech outcomes for children with cleft palate.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Ghent University Hospital
Ghent, Belgium Recruiting
Study contacts
- Study coordinator: Tara Mouton
- Email: tara.mouton@ugent.be
- Phone: +32 496 44 63 08
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Perceptions of High and Low Intensity Speech Intervention in Children with a Cleft Palate
This study looks at how providers and children with cleft palate and their parents feel about high- versus low-intensity speech therapy to see which is more acceptable and helpful.
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Comparing high and low intensity speech therapy for children with cleft palate
This study is testing whether more frequent speech therapy sessions help Belgian Dutch-speaking children with cleft palate improve their speech and overall quality of life better than fewer sessions over a longer time.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.