RecruitingNCT07781566

Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate

High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Parents and Speech-language Pathologists


Sponsor

University Ghent

Enrollment

45 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 4 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called High-intensity speech therapy for children with cleft palate and a behavioral approach called Low-intensity speech therapy for children with cleft palate for people with cleft lip and palate, cleft palate children, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 4 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALHigh-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.

BEHAVIORALLow-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.


Locations(1)

University Hospital Ghent

Ghent, East-Flanders, Belgium

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NCT07781566


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