Comparing high and low intensity speech therapy for children with cleft palate

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and cost-utility of high intensity versus low intensity speech interventions in Belgian Dutch-speaking children with cleft palate. The study will involve a randomized controlled trial comparing two different speech therapy intensities: high intensity (5 sessions per week for 2 weeks) and low intensity (2 sessions per week for 20 weeks). The primary outcomes will focus on speech quality and overall health-related quality of life, assessed by trained speech-language pathologists. Additionally, the trial will analyze the cost-effectiveness of the interventions to support potential implementation in clinical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Ghent
  Ghent, Belgium Recruiting

Study contacts

• Principal investigator: Kristiane Van Lierde, PhD — University Ghent
• Study coordinator: Fien Allemeersch
• Email: Fien.Allemeersch@UGent.be
• Phone: +32474128135

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using clear aligners to expand the upper dental arch in children with cleft lip and palate

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.