NCT06143254 Effect of Infant Sign Training on Speech-language Development
| NCT ID | NCT06143254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Cleft Palate Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-09 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-11-09 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Children born with a cleft lip and palate (CLP) are known to be at risk for speech-language disorders that impact academic and social emotional growth. Even at very young ages (\<3 years), speech-language disorders are already observed. It is hypothesized that speech-language intervention delivered before the age of 3 years old could decrease the impact of CLP on speech-language development. This would result in a decreased need for speech-language therapy on the long-term and a reduced burden of care on children, families and health services. However, no evidence is yet available to support any specific model of early speech-language intervention in this population. Consequently, no standardized clinical practice guidelines are available yet. Symbolic gesture training in combination with verbal input expands the natural communication of young children including multimodal speech-language input (i.e., verbal and manual input) via caregivers who act as co-therapists. To contribute to the evidence-based practice in the field of cleft speech therapy, this research project aims to determine the effectiveness and feasibility of symbolic gesture training in one-year old children with CLP by comparing different intervention approaches based on perceptual, psychosocial and qualitative outcome measures.
Eligibility 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
Contact & Investigator
Kristiane Van Lierde, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Ghent
Frequently Asked Questions
Who can join the NCT06143254 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 24 Months, studying Cleft Palate Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06143254 currently recruiting?
Yes, NCT06143254 is actively recruiting participants. Contact the research team at Kim.Bettens@UGent.be for enrollment information.
Where is the NCT06143254 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06143254 clinical trial?
NCT06143254 is sponsored by University Hospital, Ghent. The principal investigator is Kristiane Van Lierde, PhD at University Hospital, Ghent. The trial plans to enroll 30 participants.