Clinical trial NCT04295746: Improving Daily Living Skills in People With Autism Spectrum Disorder Through a Personalised Serious Game
Official title: Improving Daily Living Skills in People With Autism Spectrum Disorder Through a Personalised Serious Game
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism
serious game
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of a rehabilitation intervention for people with Autism Spectrum Disorder through an individualised serious game developed for improving skills related to a specific daily living activity: shopping in a supermarket.

Detailed description: Serious games are innovative computer-based interventions to support children and adults with Autism Spectrum Disorder (ASD). However, few studies have assessed the efficacy of these interventions in real-life contexts. The present study investigates the generalisation of daily living skills related to shopping activities after a rehabilitation intervention administered via a personalised serious game (ShopAut). The underlying hypothesis of this study is that training with an individualised serious game can improve performance in a real-life environment. In order to prove this hypothesis, a small sample of subjects with ASD will play an individualised serious game, ShopAut, for ten sessions. Subjects will undergo real-life experiences in a supermarket pre- and post-virtual training to determine whether there had been a generalisation of skills from the virtual environment to the real environment. Improvements in skills and performance in the real shopping activity are evaluated using specific tools.

The serious game ShopAut is developed integrating an individualised design that provides both the personalisation of the game's scenario, contents, difficulty, and user interface; and the customisation of game modes, player perspectives, and input devices. It is a three-dimensional game that provides a realistic shopping experience where the player can practice and engage with, above all, shopping activities, experiment their problem-solving skills, and take on unexpected events.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Autism Spectrum Disorder, in keeping with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
* chronological age between 8 and 16 years
* a rehabilitation plan already underway in accordance with the study's goals
* Representatives of parental authority who gave informed written consent
* native Italian speakers

Exclusion Criteria:

* no physical impairments
* participant to another research protocol
* known organic syndrome and/or non-stabilized neuropediatric (e.g. seizures) or medical (e.g. diabetes mellitus) comorbidities

Primary outcomes:
measure: change from baseline in a specific evaluation form based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY) at 11 weeks
timeFrame: baseline and 11 weeks
measure: change from baseline in Vineland Adaptive Behavior Scale II (VABS-II) at 6 months
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Vineland Adaptive Behavior Scale II (VABS-II) at 12 months
timeFrame: 12 months
measure: a specific evaluation form based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY) at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II - Centro Medico Riabilitativo Pompei
Study officials:
affiliation: Federico II University
name: Alessandro Pepino
role: STUDY_DIRECTOR
References: