Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143254
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-11-10
Brief Title:
Effect of Infant Sign Training on Speech-language Development
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
The Effect of Using Symbolic Gestures on the Speech and Language Development in Prelinguistic Children Born With Cleft Palate
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
Detailed Description:
Children with CPL are known to be at risk for speech-language delays that impact educational and social-emotional growth Early intervention in this population mostly focuses on improving verbal input via caregivers or professionals without including a multimodal language input As stated above no evidence is yet available for the effectiveness and feasibility of early intervention based on symbolic gesture training in combination with verbal input to improve speech-language skills in young children with CPL To contribute to the evidence-based practice in the field of early cleft palate speech intervention this research project will focus on the effectiveness of symbolic gesture training in one-year old children with CPL by comparing different intervention approaches based on quantitative and qualitative outcome measures This project meets the need to evaluate the impact of early intervention on speech-language outcomes in children with CPL as proposed by several researchers based on reviews regarding this topic
The primary objective is to explore if children with CPL who are enrolled in symbolic gesture training to support verbal in- and output at the age of 12 months have increased receptive and expressive language skills compared to children with CPL who are enrolled in verbal training or not involved in any intervention at all
The secondary objectives are
21 To explore if children with CPL who are enrolled in symbolic gesture training at the age of 12 months have improved speech skills compared to children with CPL who are enrolled in verbal training or not involved in any intervention at all 22 To explore if children with CPL who are enrolled in symbolic gesture training at the age of 12 months demonstrate more gesture use compared to children with CPL who are enrolled in verbal training or not involved in any intervention at all 23 To explore if caregivers of children with CPL who are enrolled in symbolic gesture training when their child is 12 months of age provide more frequent and more complex linguistic input to their childs utterances compared to caregivers of children with CPL who are enrolled in verbal training or not involved in any intervention at all
The primary objective is to explore if children with CPL who are enrolled in symbolic gesture training to support verbal in- and output at the age of 12 months have increased receptive and expressive language skills compared to children with CPL who are enrolled in verbal training or not involved in any intervention at all
The secondary objectives are
21 To explore if children with CPL who are enrolled in symbolic gesture training at the age of 12 months have improved speech skills compared to children with CPL who are enrolled in verbal training or not involved in any intervention at all 22 To explore if children with CPL who are enrolled in symbolic gesture training at the age of 12 months demonstrate more gesture use compared to children with CPL who are enrolled in verbal training or not involved in any intervention at all 23 To explore if caregivers of children with CPL who are enrolled in symbolic gesture training when their child is 12 months of age provide more frequent and more complex linguistic input to their childs utterances compared to caregivers of children with CPL who are enrolled in verbal training or not involved in any intervention at all
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None