Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388343
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-18
Brief Title:
Causes of Listening Difficulties in Children
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Causes of Listening Difficulties in Children
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:
CLINIC
Brief Summary:
Many children experience listening and processing difficulties LiD especially in background noise despite normal hearing sensitivity The prevalence of these problems is estimated at 05-1 in the general population Listening difficulties are associated with developmental disorders DD such as specific language disorders autism spectrum disorder ASD ADHD and learning disabilities Many children with developmental problems are easily distracted by sounds have difficulty concentrating for long periods processing language remembering and summarizing oral information and can experience academic difficulties reading writing Early identification differential diagnosis and intervention are important to help children overcome these difficulties and reach their full potential Some concerns about these listening and processing problems such as the lack of a gold standard to diagnose LiD and age-appropriate reference data led to the initiation of this study
CLINIC aims to develop a new approach to diagnose the causes of listening difficulties in children This is accomplished through 1 a validated parent questionnaire and 2 a multidisciplinary behavioral assessment tool Data from these combined measures will lead to evidence-based profiles of children with LiD which in turn will help streamline their referral pathways and care pathways
CLINIC aims to develop a new approach to diagnose the causes of listening difficulties in children This is accomplished through 1 a validated parent questionnaire and 2 a multidisciplinary behavioral assessment tool Data from these combined measures will lead to evidence-based profiles of children with LiD which in turn will help streamline their referral pathways and care pathways
Detailed Description:
The goal of the CLINIC project is to develop a new approach to diagnose the causes of LiD in 6 to 14-year-old children with normal peripheral hearing A multicentric interventional study focuses on the longitudinal evaluation of children with various DDs SLI LD ADHD and ASS These children are tested at different sites for three years consecutively with a multidisciplinary behavioral assessment app CLINIC that will allow assessing a broad range of skills auditory abilities speech processing skills language abilities neurocognitive abilities Profiles of children with LiD will be constructed from the ECLiPS Evaluation of Childrens Listening and Processing Skills a validated parent report questionnaire and from the behavioral measures obtained with the CLINIC app both at a population level and in specialized centers treating children with recognized DD This will be done in a longitudinal design 3 years with the same children to determine age effects and to capture potential changes in the profiles of children with time Results will be compared with performance of TD children to determine cut-off criteria for establishing a diagnosis Comparison of the ECLiPS and the behavioral measures will indicate whether the ECLiPS can be used as a screening measure in the future to help identify children in need of support and to pinpoint in which domains the support needs to be prioritized
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