Improving Daily Living Skills in People With Autism Spectrum Disorder Through a Personalised Serious Game

Not Applicable

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Serious Game ShopAut

• Registration Number: NCT04295746
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-11-30
• Study First Submitted: 2020-02-29
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Serious Game ShopAut	Serious Game ShopAut	Each participant played 10 game sessions, one per week, for no more than 30 minutes.

Primary Outcome Measures

Name	Time	Method
change from baseline in Vineland Adaptive Behavior Scale II (VABS-II) at 6 months	baseline and 6 months	The Vineland Adaptive Behavior Scale II (VABS-II) is a standardized paediatric functional assessment tool. The VABS-II offers a way to measure personal and social self-sufficiency in real-life situations and to observe how these cognitive abilities impact the autonomy management process when put into practice. The VABS-II consists in a semi-structured interview with the parents. Higher scores mean a better outcome.
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	baseline and 11 weeks	In order to describe the participants' functioning in the supermarket, an ad hoc evaluation form was created based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY). The form follows the ICF-CY scale so higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scale II (VABS-II) at 12 months	12 months	The Vineland Adaptive Behavior Scale II (VABS-II) is a standardized paediatric functional assessment tool. The VABS-II offers a way to measure personal and social self-sufficiency in real-life situations and to observe how these cognitive abilities impact the autonomy management process when put into practice. The VABS-II consists in a semi-structured interview with the parents. Higher scores mean a better outcome.
a specific evaluation form based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY) at 12 months	12 months	In order to describe the participants' functioning in the supermarket, an ad hoc evaluation form was created based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY). The form follows the ICF-CY scale so higher scores mean a worse outcome.

Trial Locations

Locations (1)

University of Naples Federico II - Centro Medico Riabilitativo Pompei; 🇮🇹 Naples, Italy