NCT06895395 High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists
| NCT ID | NCT06895395 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Cleft Lip and Palate |
| Study Type | OBSERVATIONAL |
| Enrollment | 175 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 175 participants in total. It began in 2025-05-01 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
A cleft (lip and) palate (CP±L) is the most common congenital abnormality of the face and skull with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with CP±L based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with CP±L and their caregivers). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological/audiological data will be collected from the medical records of the children with CP±L. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.
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
Frequently Asked Questions
Who can join the NCT06895395 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Cleft Lip and Palate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06895395 currently recruiting?
Yes, NCT06895395 is actively recruiting participants. Contact the research team at tara.mouton@ugent.be for enrollment information.
Where is the NCT06895395 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06895395 clinical trial?
NCT06895395 is sponsored by University Ghent. The trial plans to enroll 175 participants.