Group Intervention on Theory of Mind in Children With Autism Spectrum Disorder.

Istituto per la Ricerca e l'Innovazione Biomedica

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Other: Image stimuli; Other: QT voice

Study type: Interventional

Funder types: Other

Identifiers

NCT06179927

CNR-IRIB-PRO-2023-008

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

QT robot treatment

Experimental group

Description:

Twenty children from the experimental group will undergo the treatment using QT Robot and the tablet.

Treatment:

Other: QT voice

Traditional treatment

Experimental group

Description:

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.

Treatment:

Other: Image stimuli