CHU Toulouse - Pierre Paul Riquet
Toulouse, 31059, France
Location contact
Marie-Noelle Calmels
CONTACT
+33 (0)5 61 77 90 09 ext. 33
Marie-Noelle Calmels
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06914531
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.
Trial opening soon.
Get Notified3 year–6 year
All sexes
Observational
Toulouse, 31059, France
Marie-Noelle Calmels
CONTACT
+33 (0)5 61 77 90 09 ext. 33
Marie-Noelle Calmels
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Assessed during a single study visit (approximately 20-minute session).
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.
Time frame: Assessed during a single study visit (approximately 20-minute session)
Evaluation of the participant's ability to communicate while completing the questionnaire, including composite criterion with verbal, non-verbal (gestures, facial expressions), and mixed communication strategies. This will help assess whether children can effectively engage with the assessment.
Time frame: Assessed during a single study visit (approximately 20-minute session).
Analysis of differences in questionnaire responses among participants. Variability will be examined based on factors such as age, duration of cochlear implant use, and language proficiency to determine individual differences in social cognition development.
Time frame: Assessed during a single study visit (approximately 20-minute session).
Assessment of response consistency across participants. Identifying patterns of similarity in answers will provide insight into shared cognitive and social processing abilities in cochlear-implanted children. High homogeneity could indicate a common understanding of the instructions and uniform accessibility of the questionnaire. Conversely, marked heterogeneity could reveal differences in the cognitive strategies used or in the interpretation of the items, requiring adaptation of the questionnaire.
Time frame: Assessed during a single study visit (approximately 20-minute session).
Observation and analysis of social behaviors exhibited by participants during the questionnaire session. This is a composite criterion who includes joint attention, emotional regulation, and perspective-taking, providing insight into their social cognitive abilities.
Contact information is provided by the study sponsor or research team.
University Hospital, Toulouse
Other
Acronym: 1OL1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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