Clinical trial Recruiting at 1 site Observational Ages 4 to 12

Comparing speech interventions for children with cleft palate

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

Run by University Hospital, Ghent · NCT06895395 · Data updated 2026-11-12

This study is trying to find out if high or low intensity speech therapy works better for children with cleft palate by talking to the kids, their caregivers, and speech therapists about their experiences.

Quick facts

Study typeObservational
Ages4 Years to 12 Years
SexAll
Enrollment175 (estimated)
SponsorUniversity Hospital, Ghent
Academic / other
Locations1 site (Ghent)
StatusRecruiting
StartedMay 1, 2025
Main results expectedDecember 2027
Study endsDecember 2027
Registry record updatedMarch 26, 2025
Trial IDNCT06895395 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Belgian Dutch-speaking children aged 4 to 12 years with a cleft palate and at least one compensatory speech error.

Probably not a fit

Children with syndromic clefts, oronasal fistula, velopharyngeal insufficiency, hearing disabilities, or cognitive and related learning disabilities may not benefit from this study.

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

What this trial studies

This observational study aims to compare high and low intensity speech interventions for children with cleft palate by gathering perceptions from both speech-language pathologists and the children and their caregivers. The study will involve individual semi-structured interviews to explore experiences and acceptability of the different intervention intensities. By focusing on qualitative feedback, the research seeks to understand the social and emotional impacts of these interventions on the participants. The findings could inform future speech therapy practices for children with cleft lip and palate.

Why it matters

Potential benefit: If successful, this study could enhance speech therapy approaches for children with cleft palate, leading to improved communication outcomes and quality of life.

How similar studies have gone: While this study explores a specific qualitative approach, similar interventions have shown promise in improving speech outcomes for children with cleft palate.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Ghent University Hospital
    Ghent, Belgium
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.