Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
NCT07781566 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45
Last updated 2026-08-24
Summary
A cleft (lip and) palate 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 a cleft (lip and) palate based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with a cleft (lip and) palate and their parents). 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 a cleft (lip and) palate. 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.
Conditions
- Cleft Lip and Palate
- Cleft Palate Children
- Speech Therapy
- Speech Disorders in Children
- Intervention Intensity
Interventions
- BEHAVIORAL
-
High-intensity speech therapy for children with cleft palate
High-intensity speech therapy consisted of five 30-minute speech therapy sessions per week over two separate 2-week periods, with a 6-week rest period between the two periods. The intervention comprised a total of 10 hours of speech therapy.
- BEHAVIORAL
-
Low-intensity speech therapy for children with cleft palate
Low-intensity speech therapy consisted of two 30-minute speech therapy sessions per week over a 10-week period. The intervention comprised a total of 10 hours of speech therapy.
Sponsors & Collaborators
-
Research Foundation Flanders
collaborator OTHER -
University Ghent
lead OTHER
Principal Investigators
-
Kristiane Van Lierde, Professor · University Ghent
Eligibility
- Min Age
- 4 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2027-09-30
- Completion
- 2027-12-31
Countries
- Belgium
Study Locations
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