- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04563884
Validity of the French Version of Deafness Questionnaires for Children and Adolescents (SSQ-PEACH)
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75015
- Hôpital Necker-Enfants Malades
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with deafness
Patients aged 12 months to 17 years with deafness
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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 Names:
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Controls
Normal-hearing patients aged 12 months to 17 years
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Paired student t-test
Time Frame: 1 year
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Reproducibility of the questionnaire completed by a subject at 15 days apart
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1 year
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Cronbach alpha test
Time Frame: 1 year
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Internal consistency
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1 year
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Item-total Pearson correlation
Time Frame: 1 year
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Measure of reliability
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1 year
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Principal components analysis
Time Frame: 1 year
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Measure of efficiency
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1 year
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Receiver Operating Characteristic (ROC) curve
Time Frame: 1 year
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Limit value of normality
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1 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Françoise Denoyelle, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Otorhinolaryngologic Diseases
- Sensation Disorders
- Ear Diseases
- Hearing Loss
- Hearing Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Deafness
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- APHP200794
- 2020-A01274-35 (Other Identifier: ID RCB number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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