Clinical trial NCT04563884: Validity of the French Version of Deafness Questionnaires for Children and Adolescents
Official title: Validity of the French Version of Deafness Questionnaires for Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deafness
Keywords: Deafness
Children
SSQ questionnaire
PEACH questionnaire
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 101
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital.

Brief 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.

Detailed description: Neonatal sensorineural hearing loss is a frequent pathology, affecting around 800 newborns per year in France, or an incidence of 0.8 to 1.3 per 1000 births, comparable to other industrialized countries. It can affect the development of speech and language and lead to impaired quality of life.

Studies have shown that children with hearing loss score lower on general quality-of-life measurement tools, compared to their normal-hearing peers. A poorer quality of life in patients with sensorineural hearing loss may also reflect physical, academic, social or emotional difficulties. They are also exposed to an increased risk of poor development of language and social skills, as well as an increased risk of developing psychiatric pathologies.

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 Parents' Evaluation of Aural/Oral Performance of Children (PEACH) is a hetero-evaluation score used to study the quality of a child's communication from an early age (from 4 months in some studies) and up to 13 years. This tool is specifically designed for children with hearing aids or a cochlear implant. It has been translated into Swedish and Spanish and used in numerous international publications.

The Speech, Spatial and Qualities of Hearing Scale (SSQ) is an adult self-assessment score assessing, in three categories, the performance of speech comprehension, spatial hearing and hearing quality. It is widely used internationally in its adult version.

This adult score has been adapted and used for the pediatric population in a hetero-evaluation score by parents (SSQ-P) from 5 years old, and a simplified score (SSQ-C) usable by children\> 11 years.

In addition, the authors of the adult SSQ also prepared and validated a Handicap questionnaire to target the impact of hearing loss on quality of life, and integrated into the SSQ self-assessment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Paired student t-test
timeFrame: 1 year
measure: Cronbach alpha test
timeFrame: 1 year
measure: Item-total Pearson correlation
timeFrame: 1 year
measure: Principal components analysis
timeFrame: 1 year
measure: Receiver Operating Characteristic (ROC) curve
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Françoise Denoyelle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gargula S, Simon F, Celerier C, Couloigner V, Leboulanger N, Loundon N, Denoyelle F. French adaptation and validation of parents' evaluation of aural/oral performance of children (PEACH) scale in children. Int J Audiol. 2023 Jun;62(6):592-598. doi: 10.1080/14992027.2022.2059714. Epub 2022 May 9.