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Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate

RecruitingNAAges 4 Years - 12 YearsAllUniversity Ghent
NCT06381713 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice. Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program

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📋 Eligibility rules (as published)
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
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What it tests

  • High intensive combined phonetic-phonological intervention
  • Low intensive combined phonetic-phonological intervention
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Where

1 site
University Hospital Ghent
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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