Listening DifficultiesCLINICNCT06388343
Causes of Listening Difficulties in Children
A study testing Evaluation of Children's Listening and Processing Skills and Multidisciplinary behavioral assessment in people with Listening Difficulties, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Listening Difficulties
- What is being tested?
- Evaluation of Children's Listening and Processing Skills and Multidisciplinary behavioral assessment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6 to 14 years old
- experiencing listening difficulties
- normal or near-to-normal hearing (bilateral PTA ≤ 20 dB HL)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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).
- Conditions
- Listening Difficulties
- Being tested
- Evaluation of Children's Listening and Processing Skills, Multidisciplinary behavioral assessment
- Keywords
- Listening difficulties, Multidisciplinary behavioral assessment, ECLiPS, Profiles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Children's Listening and Processing SkillsOther
Also called ECLiPS
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.
Multidisciplinary behavioral assessmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children with listening difficulties | Experimental | Comorbid developmental disorders Longitudinal study design (3 years) ECLiPS-questionnaire + behavioral measures Receives: Other: Evaluation of Children's Listening and Processing Skills; Behavioral: Multidisciplinary behavioral assessment |
| Typically developing children | Active comparator | TD children perform the same behavioral tasks and ECLiPS-questionnaire to determine cut-off criteria for establishing a diagnosis. Receives: Other: Evaluation of Children's Listening and Processing Skills; Behavioral: Multidisciplinary behavioral assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 1, year 2, year 3
Behavioral measures
Behavioral tasks in different domains (auditory processing, speech processing, language processing, cognition) are administered.
Measured: Year 1, year 2, year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study startJan 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Listening DifficultiesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388343
- Sponsor's protocol ID
- S68485
- Acronym
- CLINIC
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes of Listening Difficulties in Children
- ClinicalTrials.gov ID
- NCT06388343
- Acronym / sponsor ID
- CLINIC / S68485
- Conditions
- Listening Difficulties
- Keywords
- Listening difficulties, Multidisciplinary behavioral assessment, ECLiPS, Profiles
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with listening difficulties | Experimental | Other: Evaluation of Children's Listening and Processing Skills, Behavioral: Multidisciplinary behavioral assessmentComorbid developmental disorders Longitudinal study design (3 years) ECLiPS-questionnaire + behavioral measures |
| Typically developing children | Active comparator | Other: Evaluation of Children's Listening and Processing Skills, Behavioral: Multidisciplinary behavioral assessmentTD children perform the same behavioral tasks and ECLiPS-questionnaire to determine cut-off criteria for establishing a diagnosis. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6 to 14 years old
- experiencing listening difficulties
- normal or near-to-normal hearing (bilateral PTA ≤ 20 dB HL)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of Children's Listening and Processing SkillsAlso: ECLiPSThe 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 | Children with listening difficulties, Typically developing children |
| Multidisciplinary behavioral assessmentBy 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. | Behavioural | Children with listening difficulties, Typically developing children |
Primary outcome
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.
Behavioral measures
Time frame: Year 1, year 2, year 3
Behavioral tasks in different domains (auditory processing, speech processing, language processing, cognition) are administered.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of Children's Listening and Processing Skills and Multidisciplinary behavioral assessment in people with Listening Difficulties, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Astrid van Wieringen, PhD (001632330478, astrid.vanwieringen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECLiPS questionnaire (time frame: Year 1, year 2, year 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.