Actively Recruiting

Phase Not Applicable
Age: 12Months - 24Months
All Genders
ID06143254

The Effect of Using Symbolic Gestures on Speech and Language Development in Young Children Born With Cleft Palate

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

30

Participants Needed

1

Research Sites

N/A

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 cleft lip and palate (CLP) often face speech-language delays that affect their learning and social growth. These issues can be seen even before age 3. Researchers are studying whether early speech-language intervention using symbolic gesture training combined with verbal input can improve language skills in one-year-old children with CLP. The study compares this approach to verbal training alone or no intervention to find effective methods for supporting speech development. The study involves three groups of children with CLP: one group whose caregivers receive training in symbolic gesture use along with verbal communication, another group whose caregivers receive verbal training only, and a control group receiving standard clinical care with information about speech development. Caregivers in the intervention groups attend three training sessions over three months, each lasting two hours, and then apply the techniques at home. After study completion, the control group caregivers may receive the most effective intervention. Participants will be assessed at 12 months old to measure receptive and expressive language skills through language tests and caregiver reports. Researchers will also evaluate the child's speech skills, gesture use, and the complexity of caregiver communication. The study uses randomized allocation and double masking. Participation includes caregiver training, language assessments, and observation of communication behaviors, aiming to provide evidence to improve early speech therapy for children with CLP.

CONDITIONS

Brief 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 (hearing threshold over 40dB in both ears)
  • Neurosensory hearing loss
  • Cognitive delay
  • Motor delay

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - 1 day

Participants undergo baseline assessments of speech and language skills before starting any intervention.

1 visit (in-person)

Caregiver Training and Intervention

Duration - 3 months

Caregivers participate in three training sessions over three months to learn either symbolic gesture training or verbal training to support their child’s speech and language development. The first training session occurs one month after baseline, with subsequent sessions at months two and three. Caregivers begin using the assigned communication support at home after the first session.

3 visits (each 2 hours, approximately monthly)

Follow-up Assessment

Duration - 1 day

Participants are assessed at 12 months of age for receptive and expressive language skills, communicative acts, and speech precision to evaluate the effects of the intervention.

1 visit (in-person)

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

K

Kristiane Van Lierde, PhD

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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Published Research Related To This Trial

A protocol for a randomized-controlled trial to investigate the effect of infant sign training on the speech-language development in young children born with cleft palate.

Mira De Ryck, Kristiane Van Lierde, Cassandra Alighieri...

https://pubmed.ncbi.nlm.nih.gov/37376898

Early Speech and Language Development in Children With Nonsyndromic Cleft Lip and/or Palate: A Meta-Analysis.

Hope Sparks Lancaster, Kari M Lien, Jason C Chow...

https://pubmed.ncbi.nlm.nih.gov/31841365

The relationship between early speech and later speech and language performance for children with cleft lip and palate.

Kathy L Chapman, Mary Hardin-Jones, Kelli Ann Halter

https://pubmed.ncbi.nlm.nih.gov/12858838

The Influences of Child Intelligibility and Rate on Caregiver Responses to Toddlers With and Without Cleft Palate.

Jennifer R Frey, Ann P Kaiser, Nancy J Scherer

https://pubmed.ncbi.nlm.nih.gov/29351026