Clinical trial NCT06914531: Assessment of the Development of Social Cognition in a Deaf Child With a Cochlear Implant : A Study Using a Standardized Questionnaire
Official title: Assessment of the Development of Social Cognition in a Deaf Child With a Cochlear Implant : A Study Using a Standardized Questionnaire
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Deaf Children
Cochlear Implant
Keywords: children
Cochlear Implants
Deafness
Social cognitive skills
Emotions skills
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: • Scientific Justification: Social cognition, particularly Theory of Mind, plays a crucial role in children's social interactions and emotional development. However, deaf children, especially those with cochlear implants, may experience delays or differences in Theory of Mind development due to limited access to spoken language and incidental learning. Assessing their social cognitive abilities requires tailored tools that accommodate their unique communication modes. This study aims to evaluate the adaptability and validity of a questionnaire designed to assess social cognition in deaf children aged 3 to 6 with cochlear implants. By analyzing communication strategies, response variability, and social interaction patterns, the research seeks to refine assessment methods, ensuring they accurately capture these children's cognitive and social competencies.

* The content of the responses: it is essential to measure this because it enables us to assess the quality of the children's reflections. Response content provides valuable insights into how deaf children with cochlear implants before 15 months perceive and interpret social interactions. This will allow us to test whether deaf children develop similar or different strategies for understanding the social world. Rich and relevant content would indicate good integration of social skills, which would be an indicator of success for the study.
* Understanding their own answers: it is important to check that the children understand what they are answering. This criterion is important because it ensures that the answers given are not the result of chance or a desirability bias, but of genuine reflection and a real understanding of social concepts. A child's understanding of his or her own responses is indicative of cognitive maturity and the ability to apply knowledge in social contexts, which is a central objective of the study.
* The degree of response, the completeness and accuracy of the answers given, is a key indicator of children's ability to understand and engage in cognitive tasks. This criterion measures the commitment and mental effort invested by the child in the exercise, as well as his or her ability to formulate detailed and relevant answers. A high level of response would be a positive sign of successful cochlear implantation in terms of cognitive and social development, while a low level of response could suggest difficulties in processing social information or expressing thoughts coherently.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Completion Rate of Standardized Social Cognition Questionnaire
timeFrame: Assessed during a single study visit (approximately 20-minute session).
Secondary outcomes:
measure: Communication Ability During Questionnaire Completion
timeFrame: Assessed during a single study visit (approximately 20-minute session)
measure: Variability of Responses Among Participants
timeFrame: Assessed during a single study visit (approximately 20-minute session).
measure: Homogeneity of Responses Within the Study Group
timeFrame: Assessed during a single study visit (approximately 20-minute session).
measure: Identification of Social Skills Demonstrated During the Assessment
timeFrame: Assessed during a single study visit (approximately 20-minute session).
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse - Pierre Paul Riquet
Study officials:
References:
citation: 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.
citation: 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.
citation: Allen MC, Nikolopoulos TP, O'Donoghue GM. Speech intelligibility in children after cochlear implantation. Am J Otol. 1998 Nov;19(6):742-6.