Actively Recruiting

Phase Not Applicable
Age: 12Months - 24Months
All Genders
NCT06143254

Effect of Infant Sign Training on Speech-language Development

Led by University Hospital, Ghent · Updated on 2024-01-30

30

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

U

University Ghent

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Infant Sign Training on Speech-language Development

Who Can Participate

Age: 12Months - 24Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Born with cleft palate (with or without cleft lip)
  • Having Dutch as mother tongue
  • Aged between 12 and 24 months
Not Eligible

You will not qualify if you...

  • Syndromic cleft
  • More than mild hearing loss (greater than 40 dB hearing threshold in both ears)
  • Neurosensory hearing loss
  • Cognitive delay
  • Motor delay

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ghent University Hospital

Ghent, East Flanders, Belgium, 9000

Actively Recruiting

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Research Team

K

Kim Bettens, PhD

CONTACT

K

Kristiane Van Lierde, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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