NCT06179927

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

Status unknown NA Last updated 22 December 2023

What this trial tests

NA trial testing QT voice in Autism Spectrum Disorder in 40 participants. Status unknown.

Timeline

16 October 2023

Primary endpoint
4 December 2023

22 January 2024

Quick facts

Lead sponsor	Istituto per la Ricerca e l'Innovazione Biomedica
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	16 October 2023
Primary completion	4 December 2023
Estimated completion	22 January 2024
Sites	1 location across Italy

Drugs / interventions tested

• QT voice
• Image stimuli

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica — full company profile →

Who can join

Adults 6 to 10, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.