Clinical trial NCT06388343: Causes of Listening Difficulties in Children
Official title: Causes of Listening Difficulties in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Listening Difficulties
Keywords: Listening difficulties
Multidisciplinary behavioral assessment
ECLiPS
Profiles
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
First posted: 2024-04-29
Enrollment: 280
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 0.5-1% 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.

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 Children's 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).

Eligibility criteria: Inclusion Criteria:

* 6 to 14 years old
* experiencing listening difficulties
* normal or near-to-normal hearing (bilateral PTA ≤ 20 dB HL)

Exclusion Criteria:

* acquired conditions (such as brain damage, neuropathy, children with cochlear implants, peripheral hearing loss, or chronic otitis media)
* Down syndrome or another syndrome
* IQ \< 70
* hearing loss

Primary outcomes:
measure: ECLiPS questionnaire
timeFrame: Year 1, year 2, year 3
measure: Behavioral measures
timeFrame: Year 1, year 2, year 3
Secondary outcomes:
Other outcomes:
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