Causes of Listening Difficulties in Children (CLINIC)

April 24, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ECLiPS questionnaire
Time Frame: Year 1, year 2, year 3
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
Time Frame: Year 1, year 2, year 3
Behavioral tasks in different domains (auditory processing, speech processing, language processing, cognition) are administered.
Year 1, year 2, year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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