Perceptions of High and Low Intensity Speech Intervention in Children with a Cleft Palate
Official title: High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Parents and Speech-language Pathologists
Run by University Ghent · NCT07781566 · Data updated 2026-11-12
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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 4 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | University Ghent Academic / other |
| Locations | 1 site (Ghent, East-Flanders) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | September 2027 |
| Study ends | December 2027 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07781566 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Belgian Dutch-speaking children aged 4–12 with cleft palate (with or without cleft lip) and at least one compensatory speech error, whose parents or guardians participate in the study.
✕Probably not a fit
Children without compensatory speech errors or with conditions excluded (e.g., syndromic clefts, certain hearing or cognitive impairments) may not experience direct benefit from this qualitative inquiry.
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 compares high- and low-intensity speech therapy for children with cleft palate. It uses semi-structured interviews with speech-language pathologists and with children and their parents to understand experiences and perceptions. The goal is to see which approach is more acceptable, feasible, and potentially beneficial in real-world primary care settings, rather than to test experimental efficacy. The study is grounded in qualitative methods and aims to inform future practice and research in speech-language therapy for cleft-related communication difficulties. No formal hypothesis testing is planned beyond exploring participant perspectives.
Why it matters
Potential benefit: If high-intensity therapy is found to be more acceptable and engaging, it could inform more patient-centered speech therapy planning for children with cleft palate.
How similar studies have gone: Qualitative work in speech therapy has shown value in understanding acceptability and experiences; this study builds on that approach in the cleft palate context.
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
-
University Hospital Ghent
Ghent, East-Flanders, Belgium Recruiting
Study contacts
- Principal investigator: Kristiane Van Lierde, Professor — University Ghent
- Study coordinator: Tara Mouton
- Email: tara.mouton@ugent.be
- Phone: +32496446308
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
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.
-
High- vs Low-Intensity Speech Therapy for Children with Phonological Speech Sounds
This study tests whether a higher-frequency speech therapy approach helps children aged 4–12 with phonological speech sound disorders more than a lower-frequency approach.
-
Comparing speech interventions for children with cleft palate
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.
-
Sedation options for suture removal after cleft surgery in young children
This trial tests whether intramuscular ketamine, intranasal nalbuphine, or intranasal dexmedetomidine provide faster, safer, and more comfortable sedation for children aged 6 months to 3 years during suture removal after cleft surgery.
-
Suprazygomatic maxillary nerve block to reduce pain and shorten hospital stay after cleft palate repair in children
This project tries a suprazygomatic maxillary nerve block in children having cleft palate repair to see if they need less morphine and can go home sooner.
-
Using clear aligners to expand the upper dental arch in children with cleft lip and palate
This study is testing if clear aligners can help expand the upper jaw in children aged 6-8 with cleft lip and palate.
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.