Actively Recruiting

Age: 4Years - 12Years
All Genders
NCT06895395

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

Led by University Ghent · Updated on 2025-03-26

175

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

Sponsors

U

University Ghent

Lead Sponsor

R

Research Foundation Flanders

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 based on assessment by an experienced speech-language pathologist
Not Eligible

You will not qualify if you...

  • Children with syndromic clefts
  • Presence of oronasal fistula
  • Velopharyngeal insufficiency
  • Hearing disabilities with hearing loss greater than 25 dB HL
  • Cognitive, learning, or neuromuscular disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ghent University Hospital

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

T

Tara Mouton

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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