Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179927
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-12
Brief Title:
Group Intervention on Theory of Mind in Children With Autism Spectrum Disorder
Sponsor:
Istituto per la Ricerca e lInnovazione Biomedica
Organization:
Istituto per la Ricerca e lInnovazione Biomedica
Study Overview
Official Title:
Enhancing Theory of Mind Skills in Children With Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The project involves the participation of 40 children with Autism Spectrum Disorder of both sexes aged between 6 and 10 years The subjects will undergo a pre-intervention evaluation phase which will consist of administering the Theory of Mind ToM test present in the NEuroPSYcology second edition NEPSY battery part A The same test will be administered again at the end of the intervention Once the inclusion criteria have been met and following the randomization of the sample divided into Experimental Group EG n20 and Control Group CG n20 the administration of the search task will proceed The study involves 12 sessions one per week lasting 45 minutes The EG will view twelve social scenes created through a tablet In the scenario the depictions will be presented in color Guided by the narrating voice of QT Robot they will have to choose between two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet Consequently an audio-visual feedback will be provided through the robot to give the subject information about the accuracy of their response In both groups a simple instruction will be given to the child telling them to pay attention to the story that will be narrated and then answer simple questions In the EG QT robot will speak while in the CG it will be the operator The prompts will be related to the accuracy of the response or they will rather be aimed at encouraging the child to give the correct answer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None