Causes of Listening Difficulties in Children (CLINIC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Listening Difficulties
• Intervention / Treatment: Other: Evaluation of Children's Listening and Processing Skills; Behavioral: Multidisciplinary behavioral assessment

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).

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Astrid van Wieringen, PhD; Phone Number: 001632330478; Email: astrid.vanwieringen@kuleuven.be
• Study Contact Backup: Name: Hanne Falcone, MSc; Phone Number: 003216376993; Email: hanne.falcone@kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children with listening difficulties; Comorbid developmental disorders Longitudinal study design (3 years) ECLiPS-questionnaire + behavioral measures	Other: Evaluation 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.; Other Names: ECLiPS; Behavioral: Multidisciplinary 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.
Active Comparator: Typically developing children; TD children perform the same behavioral tasks and ECLiPS-questionnaire to determine cut-off criteria for establishing a diagnosis.	Other: Evaluation 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.; Other Names: ECLiPS; Behavioral: Multidisciplinary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECLiPS questionnaire	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.	Year 1, year 2, year 3
Behavioral measures	Behavioral tasks in different domains (auditory processing, speech processing, language processing, cognition) are administered.	Year 1, year 2, year 3

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Listening difficulties; Multidisciplinary behavioral assessment; ECLiPS; Profiles
• Other Study ID Numbers: S68485

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No