Assessment of the Development of Social Cognition in a Deaf Child With a Cochlear Implant : A Study Using a Standardized Questionnaire

NCT06914531 | Not Yet Recruiting

• 2 other identifiers: RC31/25/0073ID-RCB : 2025-A00479-40
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the adaptability of a questionnaire assessing social cognition in children with cochlear implants aged 3 to 6 years, implanted before the age of 15 months. The primary objective is to evaluate the comprehensibility and relevance of the questionnaire in this population, considering their specific communication modes and cognitive profiles. By analysing response variability, communication abilities, and social interaction patterns, the study aims to refine the tool for accurate assessment. The findings will contribute to improving evaluation methods for social cognition in young deaf children.

Conditions

Deaf Children; Cochlear Implant

Keywords

children; Cochlear Implants; Deafness; Social cognitive skills; Emotions skills

Outcome Measures

Primary Outcomes (1)

• Completion Rate of Standardized Social Cognition Questionnaire

  The primary outcome measure is the proportion of children who successfully complete all items of the standardized social cognition questionnaire. Success is determined by the child's ability to understand and respond coherently to the questions, demonstrating engagement and cognitive processing related to social interactions and emotions.

  Assessed during a single study visit (approximately 20-minute session).

Secondary Outcomes (4)

• Communication Ability During Questionnaire Completion

  Assessed during a single study visit (approximately 20-minute session)

• Variability of Responses Among Participants

  Assessed during a single study visit (approximately 20-minute session).

• Homogeneity of Responses Within the Study Group

  Assessed during a single study visit (approximately 20-minute session).

• Identification of Social Skills Demonstrated During the Assessment

  Assessed during a single study visit (approximately 20-minute session).

Study Arms (1)

deaf child with a cochlear implant

This study focuses on children aged 3 to 6 years with congenital severe-to-profound deafness who received a cochlear implant before 15 months of age. The research aims to assess the adaptability of a standardized questionnaire evaluating social cognition in this population. Their communication abilities, response variability, and social interaction patterns are analyzed to refine assessment tools.

Other: Questionnaire comprehension test

Interventions

Questionnaire comprehension test OTHER

Participants will complete a standardized questionnaire assessing social cognition, adapted for cochlear-implanted children aged 3 to 6 years. The assessment includes the Item Scale and the Test of Emotions Comprehension adapted and mixed together. The questionnaire evaluates children's ability to understand emotions, social interactions, and cognitive perspective-taking. Each child will complete the test in a single session lasting approximately 20 minutes, under the supervision of a trained investigator, with an orthophonist and a parent present

deaf child with a cochlear implant

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children aged 3 to 6 years with congenital severe-to-profound deafness who received a cochlear implant before 15 months of age.

You may qualify if:

• Children aged 3 to 6 years old, who received a cochlear implant before the age of 15 months, who use their implant(s) and have a supportive family environment,
• Children with at least one cochlear implant undergoing speech therapy and are being monitored by the Pediatric Cochlear Implant Unit at Toulouse University Hospital,
• Children who are able to communicate: through speech, gestures, or French Sign Language,
• Children and their family whose mother tongue is French, - Social security coverage.

You may not qualify if:

• Cognitive or psychological impairment preventing the child from communicating,
• Other sensory or motor deficits that may interfere with pointing,
• Unstable psychiatric illness,
• Child whose parents both benefit from a legal protection measure.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse - Pierre Paul Riquet

Toulouse, 31059, France

Location

Related Publications (3)

• Fulcher A, Purcell AA, Baker E, Munro N. Listen up: children with early identified hearing loss achieve age-appropriate speech/language outcomes by 3 years-of-age. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1785-94. doi: 10.1016/j.ijporl.2012.09.001. Epub 2012 Oct 17.

  PMID: 23084781 BACKGROUND

• De Giacomo A, Craig F, D'Elia A, Giagnotti F, Matera E, Quaranta N. Children with cochlear implants: cognitive skills, adaptive behaviors, social and emotional skills. Int J Pediatr Otorhinolaryngol. 2013 Dec;77(12):1975-9. doi: 10.1016/j.ijporl.2013.09.015.

  PMID: 24466572 BACKGROUND

• Allen MC, Nikolopoulos TP, O'Donoghue GM. Speech intelligibility in children after cochlear implantation. Am J Otol. 1998 Nov;19(6):742-6.

  PMID: 9831147 BACKGROUND

MeSH Terms

Conditions

Deafness

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

Central Study Contacts

Marie-Noelle Calmels

CONTACT

+33 (0)5 61 77 90 09; calmels.mn@chu-toulouse.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: March 31, 2025
• Primary Completion: March 3, 2026
• Study Completion: March 3, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)