Comparing high and low intensity speech therapy for children with cleft palate
Short and Long Term Effect and Cost-utility of High Intensity vs. Low Intensity Speech Intervention in 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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | University Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Trial ID | NCT06381713 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and cost-utility of high intensity versus low intensity speech interventions in Belgian Dutch-speaking children with cleft palate. The study will involve a randomized controlled trial comparing two different speech therapy intensities: high intensity (5 sessions per week for 2 weeks) and low intensity (2 sessions per week for 20 weeks). The primary outcomes will focus on speech quality and overall health-related quality of life, assessed by trained speech-language pathologists. Additionally, the trial will analyze the cost-effectiveness of the interventions to support potential implementation in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are Belgian Dutch-speaking children aged 4 to 12 years with a cleft palate and at least one compensatory speech error.
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.
Why it matters
Potential benefit: If successful, this study could lead to improved speech outcomes and quality of life for children with cleft palate, while also reducing therapy costs.
How similar studies have performed: Previous studies have shown promising results for high intensity speech interventions, but this specific comparison is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Ghent
- University Hospital Ghent — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Kristiane Van Lierde, PhD — University Ghent
- Study coordinator: Fien Allemeersch
- Email: Fien.Allemeersch@UGent.be
- Phone: +32474128135
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.