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

NCT04295746 | Unknown

• 1 other identifier: 9820
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

autism; serious game

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline and 11 weeks

• 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.

  baseline and 6 months

Secondary Outcomes (2)

• Vineland Adaptive Behavior Scale II (VABS-II) at 12 months

  12 months

• 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

Study Arms (1)

Serious Game ShopAut

EXPERIMENTAL

Each participant played 10 game sessions, one per week, for no more than 30 minutes.

Other: Serious Game ShopAut

Interventions

Serious Game ShopAut OTHER

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.

Serious Game ShopAut

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II - Centro Medico Riabilitativo Pompei

Naples, Italy

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Alessandro Pepino

  Federico II University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 4, 2020
• Study Start: March 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: September 30, 2021
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)