Immersive VR as a Tool to Support Joint Attention Skills in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Floreo, Inc.
- 试验地点
- 2
- 主要终点
- Change from Baseline Joint Attention Protocol score at 12 weeks
研究概览
简要总结
The overall objective of this study is to determine the effectiveness of the Floreo VR Joint Attention Module in improving social communication skills in children with ASD. An additional objective is ongoing investigation of the tolerability of the product and the extent of potential adverse effects of Floreo VR, if any.
详细描述
The study will be a Phase II randomized controlled trial in which the Floreo VR Joint Attention Module is the intervention being evaluated. Floreo is a mobile application that offers a supervised virtual reality experience for individuals with ASD. The application provides a 3D immersive scene for Google Cardboard-compatible smartphones and a WiFi paired supervisory overview that can run on smartphones or tablets.
The therapeutic content will consist of a Learning Module focused on Joint Attention. This Joint Attention Learning Module will include separate Learning Cards (LCs) that address specific subskills necessary to develop appropriate joint attention. Each Learning Card will consist of a virtual reality environment in a safari-themed setting, complete with animals designed to draw the learner's attention when necessary.
The product will be implemented at The Children's SPOT by a therapist working with a client during the course of a therapy session.
The intervention arm participant would engage in one or two VR episodes during a scheduled session. Each episode would last no more than 5 minutes. If two episodes are done in a day, there is a mandatory break of at least 3 minutes in between them. The sessions would occur two days per week, with at least two days in between sessions to allow the eyes time to rest.
There are 15 total VR sessions in the protocol, and completion of all study sessions would take 8 weeks.
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented ASD diagnosis, between 7 and 17 years of age
排除标准
- •History of seizures, migraines, vertigo, psychosis
研究组 & 干预措施
VR Intervention
Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week
干预措施: Floreo Joint Attention Module (Device)
Treatment as Usual
Regularly scheduled therapy
干预措施: Regularly Scheduled Therapy (Behavioral)
结局指标
主要结局
Change from Baseline Joint Attention Protocol score at 12 weeks
时间窗: immediately before and 4 weeks after intervention or control period of the study
A measure developed to rate child behaviors on 16 items involving response to joint attention and initiation of joint attention
次要结局
- Change from Baseline Joint Attention Assessment score at 12 weeks(immediately before and 4 weeks after intervention or control period of the study)
- Change from Baseline Vineland Adaptive Behavior Scales, Third Edition total score(immediately before and 4 weeks after intervention or control period of the study)