Skip to content

Causes of Listening Difficulties in Children

Causes of Listening Difficulties in Children

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06388343
Acronym
CLINIC
Enrollment
280
Registered
2024-04-29
Start date
2025-01-31
Completion date
2027-12-31
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Listening Difficulties

Keywords

Listening difficulties, Multidisciplinary behavioral assessment, ECLiPS, Profiles

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).

Interventions

OTHEREvaluation of Children's Listening and Processing Skills

The Evaluation of Children's Listening & Processing Skills (ECLiPS; (Barry & Moore, 2021; Barry et al., 2015; Petley et al., 2021) is a caregiver-report outcome measure to profile auditory and cognitive real-world abilities important for successful listening and (auditory) processing.

BEHAVIORALMultidisciplinary behavioral assessment

By collecting behavioral measures, the investigators wish to understand the functional implications of the presented problems. Children will complete various well-chosen tasks using a tablet, in the presence of a trained clinician. Tablets are used as they are ubiquitous, cost-effective, and have excellent quality audio output. The investigators will apply the concept of differential testing (Dillon & Cameron, 2021; Lagacé et al., 2010) to narrow down the range of deficits that lead to deficient scores. The investigators distinguish four (partly overlapping) categories of behavioral measures: 1) auditory processing, 2) (nonsense) speech sound processing in quiet and in noise, excluding semantics, 3) meaningful speech in quiet and in noise, language processing, and 4) neurocognitive (including attention, memory, processing speed) processing.

Sponsors

Universitair Ziekenhuis Brussel
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ECLiPS questionnaireYear 1, year 2, year 3The Evaluation of Children's Listening & Processing Skills (ECLiPS; Barry & Moore, 2021; Barry et al., 2015; Petley et al., 2021) is a caregiver-report outcome measure to profile auditory and cognitive real-world abilities important for successful listening and (auditory) processing.
Behavioral measuresYear 1, year 2, year 3Behavioral tasks in different domains (auditory processing, speech processing, language processing, cognition) are administered.

Contacts

Primary ContactAstrid van Wieringen, PhD
astrid.vanwieringen@kuleuven.be001632330478
Backup ContactHanne Falcone, MSc
hanne.falcone@kuleuven.be003216376993

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026