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Can the pace of speech therapy make a difference for kids with cleft palate?

NCT ID NCT07781566

Knowledge-focused Sponsor: University Ghent Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study investigates how children with cleft palate, their parents, and speech-language pathologists perceive high-intensity versus low-intensity speech therapy. High-intensity therapy involves five 30-minute sessions per week over two 2-week periods, while low-intensity therapy consists of two 30-minute sessions per week over 10 weeks, both totaling 10 hours. Through interviews, the research aims to understand the acceptability and feasibility of these different therapy schedules, potentially guiding future treatment protocols.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High-intensity and low-intensity speech therapy (behavioral intervention)
What this could lead to
If successful, this could help tailor speech therapy for children with cleft palate to be more acceptable and effective, potentially improving speech outcomes and quality of life.
What could go wrong
This is a small qualitative study (45 participants) focusing on perceptions, not clinical outcomes. Results may not generalize to all children or settings, and the therapy intensity may not suit everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of children with cleft palate who participated in the associated randomized clinical trial evaluating high- and low-intensity speech therapy, their parents/caregivers, and the speech-language pathologists who provided the intervention. Participants will be selected from children and families enrolled in the clinical trial and from the speech-language pathologists providing the trial interventions.

Ages

4 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

cleft lip cleft lip/palate cleft palate communication disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cleft lip and palate Cleft palate children Intervention intensity Speech disorders in children Speech therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital Ghent

    RECRUITING

    Ghent, East-Flanders, 9000, Belgium

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