Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917496
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2023-06-14
Brief Title:
Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
ACLEIC
Brief Summary:
The language environment that influences the childs language development has been studied using different subjective tools mainly audio andor video recording and manual transcriptions The linguistic results of the implanted deaf child are dependent on the age at the implant but also on the auditory and linguistic stimulation in the first months following the placement of the implant Parents are the main actors in the childs language development Professionals can rely on the LENA tool Language ENvironment Analysis which objectifies the language environment of the child at home in his daily environment It is possible to obtain statistics on the number of adult words received by the child the number of words produced by the child as well as the exposure to media and noise On the basis of this quantitative data the family can be supported in an attempt to optimize the conditions for receiving their childs speech
The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis LENA tool in a pediatric population implanted early ie before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study
The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis LENA tool in a pediatric population implanted early ie before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study
Detailed Description:
The language environment that influences the childs language development has been studied using different subjective tools mainly audio andor video recording and manual transcriptions The linguistic results of the implanted deaf child are dependent on the age at the implant but also on the auditory and linguistic stimulation in the first months following the placement of the implant Parents are the main actors in the childs language development Professionals can rely on the LENA tool Language ENvironment Analysis which objectifies the language environment of the child at home in daily environment On the basis of this quantitative data provided by the LENA the family can be supported in an attempt to optimize the conditions for receiving their childs speech
The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis LENA tool in a pediatric population implanted early ie before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study
The LENA tool was validated in French version in 2015 It is a system of recording and automatic analysis of the language environment of the child using a box worn for 10-16 hours with a minimum of 10 consecutive hours For the study the families make 2 separate recordings of 6 months at home T1 and T2 then a centralized analysis of all the data is carried out by the speech therapist using adapted software the LENA Pro Version Software v34 during the times T1 and T2 The return of the analysis of the data collected via the LENA will be made to the family after T1 and after T2
The parameters resulting from this analysis relate to four domains adult words conversation turns child vocalizations and exposure to electronic media Average numerical scores expressed in percentiles are published at the end of the analysis Individual scores are then compared to a standard expressed as percentiles The content of the conversations will not be listened to and only numerical scores will be used for each of the parameters studied and obtained by computer analysis
The purpose of this study is to analyze the effect of speech therapy parental support using the data provided by the Language ENvironment Analysis LENA tool in a pediatric population implanted early ie before the age of 18 months and aged under 24 months inclusive at the start of their participation in the study
The LENA tool was validated in French version in 2015 It is a system of recording and automatic analysis of the language environment of the child using a box worn for 10-16 hours with a minimum of 10 consecutive hours For the study the families make 2 separate recordings of 6 months at home T1 and T2 then a centralized analysis of all the data is carried out by the speech therapist using adapted software the LENA Pro Version Software v34 during the times T1 and T2 The return of the analysis of the data collected via the LENA will be made to the family after T1 and after T2
The parameters resulting from this analysis relate to four domains adult words conversation turns child vocalizations and exposure to electronic media Average numerical scores expressed in percentiles are published at the end of the analysis Individual scores are then compared to a standard expressed as percentiles The content of the conversations will not be listened to and only numerical scores will be used for each of the parameters studied and obtained by computer analysis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00405-40 | OTHER | IDRCB Number | None |