Clinical trial Recruiting at 1 site Observational Ages 4 and up

Perceptions of High and Low Intensity Speech Intervention in Children with a Cleft Palate

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

Run by University Ghent · NCT07781566 · Data updated 2026-11-12

This study looks at how providers and children with cleft palate and their parents feel about high- versus low-intensity speech therapy to see which is more acceptable and helpful.

Quick facts

Study typeObservational
Ages4 Years and up
SexAll
Enrollment45 (estimated)
SponsorUniversity Ghent
Academic / other
Locations1 site (Ghent, East-Flanders)
StatusRecruiting
StartedMarch 1, 2025
Main results expectedSeptember 2027
Study endsDecember 2027
Registry record updatedAugust 24, 2026
Trial IDNCT07781566 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Belgian Dutch-speaking children aged 4–12 with cleft palate (with or without cleft lip) and at least one compensatory speech error, whose parents or guardians participate in the study.

Probably not a fit

Children without compensatory speech errors or with conditions excluded (e.g., syndromic clefts, certain hearing or cognitive impairments) may not experience direct benefit from this qualitative inquiry.

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 compares high- and low-intensity speech therapy for children with cleft palate. It uses semi-structured interviews with speech-language pathologists and with children and their parents to understand experiences and perceptions. The goal is to see which approach is more acceptable, feasible, and potentially beneficial in real-world primary care settings, rather than to test experimental efficacy. The study is grounded in qualitative methods and aims to inform future practice and research in speech-language therapy for cleft-related communication difficulties. No formal hypothesis testing is planned beyond exploring participant perspectives.

Why it matters

Potential benefit: If high-intensity therapy is found to be more acceptable and engaging, it could inform more patient-centered speech therapy planning for children with cleft palate.

How similar studies have gone: Qualitative work in speech therapy has shown value in understanding acceptability and experiences; this study builds on that approach in the cleft palate context.

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

  • University Hospital Ghent
    Ghent, East-Flanders, 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.