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

NCT04563884 | Completed

• 2 other identifiers: APHP2007942020-A01274-35
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness

Keywords

Deafness; Children; SSQ questionnaire; PEACH questionnaire

Outcome Measures

Primary Outcomes (5)

• Paired student t-test

  Reproducibility of the questionnaire completed by a subject at 15 days apart

  1 year

• Cronbach alpha test

  Internal consistency

  1 year

• Item-total Pearson correlation

  Measure of reliability

  1 year

• Principal components analysis

  Measure of efficiency

  1 year

• Receiver Operating Characteristic (ROC) curve

  Limit value of normality

  1 year

Study Arms (2)

Patients with deafness

Patients aged 12 months to 17 years with deafness

Other: Questionnaires

Controls

Normal-hearing patients aged 12 months to 17 years

Other: Questionnaires

Interventions

Questionnaires OTHER

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.

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

Controls; Patients with deafness

Eligibility Criteria

• Age: 12 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• Examination of the normal eardrums
• No history of ear surgery

You may not qualify if:

• Psychomotor retardation
• Abnormal neurological examination
• Mother tongue of the child and parents other than French

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 35533092 RESULT

MeSH Terms

Conditions

Deafness

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Françoise Denoyelle, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: October 4, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)