CompletedNot Applicable

Validity of the French Version of Deafness Questionnaires for Children and Adolescents

France101 participantsStarted 2020-10-04

Plain-language summary

The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone. Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population. Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations. The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group. The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.

Who can participate

Age range

12 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Minors aged 12 months to 17 years (inclusive) * Patients followed in consultation at Necker Hospital in the Pediatric ENT department * holders of parental authority not opposed to participation in the study Patients : * Patients with deafness with mean tonal thresholds of at least 30dB, uni- or bilateral * Perceptual or transmission deafness or mixed Controls: * Patients not presenting a hearing disorder at the time of inclusion or in his or her history * Examination of the normal eardrums * No history of ear surgery Exclusion Criteria: * Psychomotor retardation * Abnormal neurological examination * Mother tongue of the child and parents other than French

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Paired student t-test

Timeframe: 1 year

Cronbach alpha test

Timeframe: 1 year

Item-total Pearson correlation

Timeframe: 1 year

Principal components analysis

Timeframe: 1 year

Receiver Operating Characteristic (ROC) curve

Timeframe: 1 year

Trial details

NCT IDNCT04563884

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12-31

View on ClinicalTrials.gov More Deafness trials

Plain-language summary

Who can participate

Age range

12 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.