Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate
Launched by UNIVERSITY GHENT · Apr 19, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of two different types of speech therapy for children with cleft palates. Traditionally, speech therapy has been provided at a low intensity, which means kids usually attend sessions for 30 minutes, twice a week. However, this approach has some drawbacks, such as slow progress and high costs. The trial aims to compare this low-intensity therapy with a high-intensity option, which involves more frequent sessions, to see which one helps children speak better, improves their quality of life, and is more cost-effective.
To participate in the trial, children need to be Belgian Dutch speakers, aged 4 to 12, and have a cleft palate with at least one specific speech error. Unfortunately, children with certain medical conditions, like hearing problems or cognitive disabilities, cannot join. Those who do participate can expect to receive either the high or low-intensity speech therapy and contribute to important research that could improve treatment options for future patients. The ultimate goal is to make the best therapy available for children with cleft palates and raise awareness about its benefits.
Gender
ALL
Eligibility 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
About University Ghent
University Ghent is a prestigious Belgian research institution renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a multidisciplinary approach, the university fosters collaboration among leading experts in various fields, ensuring rigorous study design and ethical standards. University Ghent is dedicated to exploring new therapeutic modalities and enhancing healthcare outcomes, making significant contributions to both local and global health landscapes. Its state-of-the-art facilities and emphasis on research excellence position it as a pivotal sponsor in the realm of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ghent, , Belgium
Patients applied
Trial Officials
Kristiane Van Lierde, PhD
Principal Investigator
University Ghent
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported