Improving Daily Living Skills in People With Autism Spectrum Disorder Through a Personalised Serious Game
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Serious Game ShopAut
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring autism, serious game
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
Sites / Locations
- University of Naples Federico II - Centro Medico Riabilitativo Pompei
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Serious Game ShopAut
Arm Description
Each participant played 10 game sessions, one per week, for no more than 30 minutes.
Outcomes
Primary Outcome Measures
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
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.
change from baseline in Vineland Adaptive Behavior Scale II (VABS-II) at 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.
Secondary Outcome Measures
Vineland Adaptive Behavior Scale II (VABS-II) at 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
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.
Full Information
NCT ID
NCT04295746
First Posted
February 29, 2020
Last Updated
July 21, 2020
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT04295746
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism, serious game
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Serious Game ShopAut
Arm Type
Experimental
Arm Description
Each participant played 10 game sessions, one per week, for no more than 30 minutes.
Intervention Type
Other
Intervention Name(s)
Serious Game ShopAut
Intervention Description
The serious game ShopAut, is a three-dimensional game conceptually based on classic 3D life simulation games. ShopAut aims to teach players the procedure of a shopping activity; to reinforce object categorization and recognition in a supermarket; to improve attention, orientation, and problem-solving skills; and to help the player engage in simple economic transactions.
The intervention provides a virtual training with ShopAut to train, experiment, and practice behaviours and actions that can be then transferred in real-life contexts.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
baseline and 11 weeks
Title
change from baseline in Vineland Adaptive Behavior Scale II (VABS-II) at 6 months
Description
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.
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scale II (VABS-II) at 12 months
Description
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.
Time Frame
12 months
Title
a specific evaluation form based on the International Classification of Functioning, Disability and Health: children and youth version (ICF-CY) at 12 months
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Pepino
Organizational Affiliation
Federico II University
Official's Role
Study Director
Facility Information:
Facility Name
University of Naples Federico II - Centro Medico Riabilitativo Pompei
City
Naples
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Daily Living Skills in People With Autism Spectrum Disorder Through a Personalised Serious Game
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