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Clinical Trials/NCT06179927
NCT06179927
Recruiting
N/A

Enhancing Theory of Mind Skills in Children With Autism Spectrum Disorder.

Istituto per la Ricerca e l'Innovazione Biomedica1 site in 1 country40 target enrollmentOctober 16, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Enrollment
40
Locations
1
Primary Endpoint
NEuroPSYcology second edition (NEPSY-II) evaluations
Status
Recruiting
Last Updated
2 years ago

Overview

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 n=20) and Control Group (CG n=20), 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.

Registry
clinicaltrials.gov
Start Date
October 16, 2023
End Date
January 22, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Responsible Party
Principal Investigator
Principal Investigator

Flavia Marino

Head of Unit

Istituto per la Ricerca e l'Innovazione Biomedica

Eligibility Criteria

Inclusion Criteria

  • Proven diagnosis of autism
  • QS ≥ 75 assessed by administration of the GRIFFITHS scales
  • Passing the emotional recognition test of the NEPSY II battery

Exclusion Criteria

  • presence of other medical disorders

Outcomes

Primary Outcomes

NEuroPSYcology second edition (NEPSY-II) evaluations

Time Frame: The tests will be scheduled pre intervention (T0), at 6 months (T1) and at the study conclusion, about 1 year (T2).The test needs about 120-180 minutes.

NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age. Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min \<2% - max \>75%) according to the conversion tables in the manual. For each sub-scale higher scores correspond to better performance. NESPY's Theory of Mind (ToM) sub test, section A is used in this protocol. Assesses the ability to decode and interpret others' intentions and life points and understand how they influence behavior. the test will be given to children pre- and post-intervention. The ToM test is divided into verbal: the child is read scenarios or shown figures and asked questions that require understanding of the other's point of view; nonverbal: the child is asked to choose the emotional expression appropriate to the mood of a character depicted in certain contexts.

Study Sites (1)

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