Group Intervention on Theory of Mind in Children With Autism Spectrum Disorder.
NCT ID: NCT06179927
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2023-10-16
2024-01-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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QT robot treatment
Twenty children from the experimental group will undergo the treatment using QT Robot and the tablet.
QT voice
The subjects will undergo a pre-intervention assessment phase that will consist of administering the Theory Of Mind (TOM) test found in the NEuroPSYcology second edition (NEPSY) battery, part A; the same test will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the Experimental Group constituted of 20 children, will be administered the research task, which involves 12 sessions, one per week lasting 45 minutes. the experimental group will view 12 social scenes made via tablet. In the scenario, the depictions will be presented in color. They, guided by QT Robot's narrator voice, will have to choose from two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet. Consequently, audio visual feedback will be provided, via the robot, to return information to the subject about the accuracy of the response.
Traditional treatment
Twenty children belonging to the control group will be subjected to the same training but in a traditional way, that is, by presenting image stimuli in a paper format.
Image stimuli
The subjects will undergo a pre-intervention assessment phase that will consist of administering the Theory Of Mind (TOM) test found in the NEuroPSYcology second edition (NEPSY) battery, part A; the same test will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the control group constituted of 20 children, will be administered the research task, which involves 12 sessions, one per week lasting 45 minutes. the experimental group will view 12 social scenes on paper. They, guided by the narrator's voice of the operator will have to choose from two or three alternatives the one that represents the appropriate mental state by indicating it on the paper. Consequently, feedback will be provided by the operator to return information to the subject on the accuracy of the response.
Interventions
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QT voice
The subjects will undergo a pre-intervention assessment phase that will consist of administering the Theory Of Mind (TOM) test found in the NEuroPSYcology second edition (NEPSY) battery, part A; the same test will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the Experimental Group constituted of 20 children, will be administered the research task, which involves 12 sessions, one per week lasting 45 minutes. the experimental group will view 12 social scenes made via tablet. In the scenario, the depictions will be presented in color. They, guided by QT Robot's narrator voice, will have to choose from two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet. Consequently, audio visual feedback will be provided, via the robot, to return information to the subject about the accuracy of the response.
Image stimuli
The subjects will undergo a pre-intervention assessment phase that will consist of administering the Theory Of Mind (TOM) test found in the NEuroPSYcology second edition (NEPSY) battery, part A; the same test will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the control group constituted of 20 children, will be administered the research task, which involves 12 sessions, one per week lasting 45 minutes. the experimental group will view 12 social scenes on paper. They, guided by the narrator's voice of the operator will have to choose from two or three alternatives the one that represents the appropriate mental state by indicating it on the paper. Consequently, feedback will be provided by the operator to return information to the subject on the accuracy of the response.
Eligibility Criteria
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Inclusion Criteria
* QS ≥ 75 assessed by administration of the GRIFFITHS scales
* Passing the emotional recognition test of the NEPSY II battery
Exclusion Criteria
6 Years
10 Years
ALL
No
Sponsors
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Messina, Italy
OTHER
Istituto per la Ricerca e l'Innovazione Biomedica
OTHER
Responsible Party
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Flavia Marino
Head of Unit
Principal Investigators
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Flavia Marino
Role: PRINCIPAL_INVESTIGATOR
Istituto per la Ricerca e l'Innovazione Biomedica
Locations
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Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, , Italy
Countries
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Central Contacts
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Facility Contacts
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Flavia Marino
Role: primary
Giovanni Pioggia
Role: backup
References
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Lecce S & Bianco F. Mettiti nei miei panni, Erickson 2018
Begeer S, Howlin P, Hoddenbach E, Clauser C, Lindauer R, Clifford P, Gevers C, Boer F, Koot HM. Effects and Moderators of a Short Theory of Mind Intervention for Children with Autism Spectrum Disorder: A Randomized Controlled Trial. Autism Res. 2015 Dec;8(6):738-48. doi: 10.1002/aur.1489. Epub 2015 Apr 6.
Helen Tager-Flusberg, Evaluating the Theory-of-Mind Hypothesis of Autism, 2007
Uta Frith, Autism and Theory of mind in everyday life, 2018
Other Identifiers
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CNR-IRIB-PRO-2023-008
Identifier Type: -
Identifier Source: org_study_id