Clinical trial NCT06895395: High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists
Official title: High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cleft Lip and Palate
Speech Disorders in Children
Keywords: Cleft lip and palate
Qualitative research
Speech therapy
Interviews
Speech intervention intensity
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2025-03-26
Enrollment: 175
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population are children born with a cleft palate (with or without a cleft lip). They are 4 to 12 years old and have at least one compensatory speech error in their speech.

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

Primary outcomes:
measure: Perceptions and acceptability of low/high intensive speech intervention
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
References: