Validity of the French Version of Deafness Questionnaires for Children and Adolescents (SSQ-PEACH)

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ClinicalTrials.gov Identifier: NCT04563884

Recruitment Status : Completed

First Posted : September 25, 2020

Last Update Posted : September 28, 2021

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment
Deafness	Other: Questionnaires

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.

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.

Study Design

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Study Type :	Observational
Actual Enrollment :	101 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	Validity of the French Version of Deafness Questionnaires for Children and Adolescents
Actual Study Start Date :	October 4, 2020
Actual Primary Completion Date :	December 31, 2020
Actual Study Completion Date :	December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Nonsyndromic hearing loss

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Patients with deafness Patients aged 12 months to 17 years with deafness	Other: Questionnaires Children 12 months to 5 years old will receive PEACH alone, children 5 years old to 11 years old will receive PEACH and SSQ-P, and children and adolescents over 11 years old will receive SSQ-P and SSQ-C (even between 11 and 13 years old, the PEACH also). Questionnaires will be completed twice, 15 days apart. Other Name: The Parents' Evaluation of Aural/Oral Performance of Children (PEACH). The Speech, Spatial and Qualities of Hearing Scale (SSQ)
Controls Normal-hearing patients aged 12 months to 17 years	Other: Questionnaires Children 12 months to 5 years old will receive PEACH alone, children 5 years old to 11 years old will receive PEACH and SSQ-P, and children and adolescents over 11 years old will receive SSQ-P and SSQ-C (even between 11 and 13 years old, the PEACH also). Questionnaires will be completed twice, 15 days apart. Other Name: The Parents' Evaluation of Aural/Oral Performance of Children (PEACH). The Speech, Spatial and Qualities of Hearing Scale (SSQ)

Group/Cohort

Intervention/treatment

Patients with deafness

Patients aged 12 months to 17 years with deafness

Other: Questionnaires

Children 12 months to 5 years old will receive PEACH alone, children 5 years old to 11 years old will receive PEACH and SSQ-P, and children and adolescents over 11 years old will receive SSQ-P and SSQ-C (even between 11 and 13 years old, the PEACH also).

Questionnaires will be completed twice, 15 days apart.

Other Name: The Parents' Evaluation of Aural/Oral Performance of Children (PEACH). The Speech, Spatial and Qualities of Hearing Scale (SSQ)

Controls

Normal-hearing patients aged 12 months to 17 years

Other: Questionnaires

Questionnaires will be completed twice, 15 days apart.

Other Name: The Parents' Evaluation of Aural/Oral Performance of Children (PEACH). The Speech, Spatial and Qualities of Hearing Scale (SSQ)

Outcome Measures

Primary Outcome Measures :

Paired student t-test [ Time Frame: 1 year ]
Reproducibility of the questionnaire completed by a subject at 15 days apart
Cronbach alpha test [ Time Frame: 1 year ]
Internal consistency
Item-total Pearson correlation [ Time Frame: 1 year ]
Measure of reliability
Principal components analysis [ Time Frame: 1 year ]
Measure of efficiency
Receiver Operating Characteristic (ROC) curve [ Time Frame: 1 year ]
Limit value of normality

Eligibility Criteria

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Ages Eligible for Study:	12 Months to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients followed by the Pediatric ENT department of Necker-Enfants Malades hospital.

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563884

Locations

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France
Hôpital Necker-Enfants Malades
Paris, France, 75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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Principal Investigator:	Françoise Denoyelle, MD, PhD	Assistance Publique - Hôpitaux de Paris

More Information

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Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT04563884
Other Study ID Numbers:	APHP200794 2020-A01274-35 ( Other Identifier: ID RCB number )
First Posted:	September 25, 2020 Key Record Dates
Last Update Posted:	September 28, 2021
Last Verified:	September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Assistance Publique - Hôpitaux de Paris:


Deafness Children SSQ questionnaire PEACH questionnaire

Additional relevant MeSH terms:

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Deafness Hearing Loss Hearing Disorders Ear Diseases	Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases

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