Training infants with cleft palate to use signs for better speech development
The Effect of Using Symbolic Gestures on the Speech and Language Development in Prelinguistic Children Born With Cleft Palate
This study tests whether teaching one-year-old children with cleft palate to use signs along with talking can help them develop better speech skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Months to 24 Months |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, East Flanders) |
| Trial ID | NCT06143254 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of symbolic gesture training combined with verbal input for improving speech-language development in children with cleft palate. It focuses on one-year-old children, comparing outcomes between those receiving gesture training, those receiving verbal training, and those with no intervention. The goal is to determine if early intervention can enhance language skills and reduce the long-term need for speech therapy. The study aims to fill the gap in evidence-based practices for early speech intervention in this population.
Who should consider this trial
Good fit: Ideal candidates are one-year-old children born with a cleft palate who speak Dutch.
Not a fit: Patients with syndromic cleft, significant hearing loss, cognitive delays, or motor delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve speech-language outcomes for children with cleft palate, leading to better academic and social-emotional development.
How similar studies have performed: While similar approaches have been explored, this specific intervention combining gesture training with verbal input is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Born with cleft palate (with or without cleft lip) * Having Dutch as mother tongue Exclusion Criteria: * syndromic cleft * more than mild hearing loss (i.e. \> 40dB hearing threshold bilaterally) * neurosensory hearing loss * cognitive delay * motor delay
Where this trial is running
Ghent, East Flanders
- Ghent University Hospital — Ghent, East Flanders, Belgium (Recruiting)
Study contacts
- Principal investigator: Kristiane Van Lierde, PhD — University Hospital, Ghent
- Study coordinator: Kim Bettens, PhD
- Email: Kim.Bettens@UGent.be
- Phone: +32 9 332 94 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.