NCT06381713 Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate
| NCT ID | NCT06381713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Cleft Palate Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-11-26 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice. Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.
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
Contact & Investigator
Kristiane Van Lierde, PhD
PRINCIPAL INVESTIGATOR
University Ghent
Frequently Asked Questions
Who can join the NCT06381713 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Cleft Palate Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06381713 currently recruiting?
Yes, NCT06381713 is actively recruiting participants. Contact the research team at Fien.Allemeersch@UGent.be for enrollment information.
Where is the NCT06381713 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06381713 clinical trial?
NCT06381713 is sponsored by University Ghent. The principal investigator is Kristiane Van Lierde, PhD at University Ghent. The trial plans to enroll 70 participants.