A Randomized Controlled Trial on the Effectiveness of Virtual Reality-assisted Executive Function Training in Autistic and ADHD Youth
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Leiter-3
研究概览
简要总结
This study aims to evaluate the effectiveness of a virtual reality-based intervention using the Virtual Reality Rehabilitation System (VRRS) to improve executive functions in autistic and ADHD youth aged 8 to 18 years. Executive functions, such as working memory, cognitive flexibility, and inhibitory control, are frequently impaired in individuals with autism and/or ADHD and significantly affect daily functioning. Participants will be randomly assigned to either an experimental group that receives VRRS-assisted cognitive training or a control group that receives treatment as usual. The intervention includes gamified tasks within immersive virtual environments specifically designed to stimulate executive skills. The primary outcome is the change in executive function scores from baseline to post-intervention, assessed using validated neuropsychological instruments. The study adopts a randomized controlled design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8 and 18 years at enrollment
- •Clinical diagnosis of Autism Spectrum Disorder and Attention- Deficit/Hyperactivity Disorder, based on DSM-5 criteria
- •Signed Informed consent provided by a parent or legal guardian;
- •No acute or chronic medical conditions
排除标准
- •Age not between 8 and 18 years at enrollment
- •Lack of a clinical diagnosis of Autism Spectrum Disorder or Attention-Deficit/Hyperactivity Disorder
- •Failure to sign informed consent from a parent or legal guardian;
- •Presence of acute or chronic medical conditions
研究组 & 干预措施
VRRS Cognitive Training
The intervention consists of 20 individual sessions using the Virtual Reality Rehabilitation System (VRRS). Each session lasts 45 minutes and is held biweekly. The project aims to stimulate and improve memory and executive functions, such as planning and attention, in children with ASD and ADHD. The VRRS platform integrates semi-immersive and interactive cognitive exercises in a virtual environment, increasing engagement and motivation. Tasks are progressively adapted to the participant's level and performance.
干预措施: VRRS Cognitive Training (Behavioral)
Treatment As Usual
Participants in this group will begin traditional CBT intervention without the use of virtual reality technology.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Leiter-3
时间窗: T0(baseline)-T1(6months)
The Leiter-3 is a nonverbal, standardized cognitive assessment tool designed to evaluate intellectual functioning, attention, and memory in children and adolescents. In this study, selected subtests from the Leiter-3 will be used not only to estimate nonverbal IQ, but also to assess attentional control and memory capacity at both baseline and post-intervention. Administering the Leiter-3 at T0 and T1 allows for the comparison of pre- and post-intervention cognitive functioning without the confounding effects of language. Scaled scores from the Reasoning, Attention/Memory, and Processing Speed subdomains will be analyzed.
Tower of London
时间窗: T0(baseline)-T1(6months)
The Tower of London (ToL) is a standardized neuropsychological test used to assess higher-order executive functions, particularly planning, problem-solving, and working memory.
NEPSY-II
时间窗: T0(baseline)-T1(6months)
Subtests from the NEPSY-II (e.g., Auditory Attention and Response Set, Inhibition) will be administered to evaluate selective attention, sustained attention, cognitive flexibility, and the ability to shift between task demands. These measures are developmentally appropriate and widely used to detect attentional and executive control difficulties in children and adolescents with neurodevelopmental conditions.
次要结局
- Conners Rating Scales(T0(baseline)-T1(6months))
- Child Behavior Checklist (CBCL)(T0(baseline)-T1(6months))
- Short Sensory Profile (SSP)(T0(baseline)-T1(6months))
- Repetitive Behavior Scale-Revised (RBS-R)(T0(baseline)-T1(6months))
- Quality of Life in Autism Questionnaire (QoLA)(T0(baseline)-T1(6months))