跳至主要内容
临床试验/NCT04295746
NCT04295746Unknown不适用

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

Federico II University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
change from baseline in Vineland Adaptive Behavior Scale II (VABS-II) at 6 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

change from baseline in Vineland Adaptive Behavior Scale II (VABS-II) at 6 months

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ersilia Vallefuoco

PhD

Federico II University

研究点 (1)

Loading locations...

相似试验