Clinical trial NCT06179927: Group Intervention on Theory of Mind in Children With Autism Spectrum Disorder.
Official title: Enhancing Theory of Mind Skills in Children With Autism Spectrum Disorder.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
children
theory of mind
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2023-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: NEuroPSYcology second edition (NEPSY-II) evaluations
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lecce S & Bianco F. Mettiti nei miei panni, Erickson 2018
citation: 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.
citation: Helen Tager-Flusberg, Evaluating the Theory-of-Mind Hypothesis of Autism, 2007
citation: Uta Frith, Autism and Theory of mind in everyday life, 2018