A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children With Autism Using VR Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Floreo, Inc.
- 入组人数
- 117
- 试验地点
- 34
- 主要终点
- Autism Impact Measure (AIM)
研究概览
简要总结
The goal of this randomized clinical trial is to compare and learn about Virtual Reality (VR) in children with autism/Autistic children.
The main question it aims to answer is:
• Does the Floreo VR clinical product show clinical improvement in autism symptoms?
Participants will engage the VR product for twice a week for twelve weeks.
They will be randomized to either the Floreo Clinical Product or a VR Control group experience.
Researchers will compare the two groups to see if there is an effect on learning specific skills and behaviors.
详细描述
The purpose of this study is to find out if Floreo's VR clinical program can help with autism symptoms such as social communication skills in autistic children. Recent advances in VR technology offers a new way to improve these types of skills in children with autism in an immersive and controlled environment.
Questionnaires answered by adult caregivers will be used to assess the child's behaviors during the time of treatment.
Clinician observations will also be conducted as a part of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant and their adult caregiver will be blinded. The Outcomes Assessor (Clinician) with the adult caregiver will also be blinded.
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Five to eighteen years old (inclusive) at the time of consent
- •Legal guardian is able and willing to properly sign and date informed consent indicating that they have been informed about the study and able to complete all visits [If age appropriate, an assent will also be administered to the participant to inform them of the study and give them an opportunity to proceed or decline]
- •Verified diagnosis of ASD documented by a qualified clinician according to DSM-V criteria
- •Receiving therapies at least two times per week in a clinic setting
- •Participant is able to complete and pass the VR orientation screening
排除标准
- •Significant medical condition(s) [examples listed below] or other circumstances which, in the opinion of the treating clinician, would preclude compliance with the protocol, adequate cooperation in the study, or may prevent the participant from safely participating in the study:
- •Uncontrolled neurological conditions such as epilepsy, migraine
- •Current disorders affecting balance, such as vertigo
- •Primary sensory impairment such as blindness or deafness
- •Eye movement impairment, such as strabismus
- •Participants are enrolled in another clinical study
- •Participants known to be pregnant
- •Participation in this study is not in the best interest of the child, at the discretion of the treating clinician and the primary investigator.
研究组 & 干预措施
Floreo VR
Floreo VR is a 12 week program
干预措施: Floreo VR (Device)
VR Control
VR Control is a 12 week program that matches the Floreo VR interactions
干预措施: VR Control (Device)
VR Control Crossover
For participants who opt in, they will run the 12 week Floreo VR program
干预措施: Floreo VR (Device)
VR Control Crossover
For participants who opt in, they will run the 12 week Floreo VR program
干预措施: VR Control Crossover (Device)
结局指标
主要结局
Autism Impact Measure (AIM)
时间窗: Baseline-12 weeks
The primary objective of this study is to determine if administration of the Floreo VR compared to VR Control results in clinically significant improvement in autism symptoms as measured by the Autism Impact Measure (AIM) in the study participant population.
次要结局
- Assessment of Functional Living Skills (AFLS)(Baseline-12 weeks)
- Child and Family Quality of Life (CFQL-2)(Baseline-12 weeks)
- Total Autism Impact Measure (AIM) Score(baseline, 16 weeks, 20 weeks, 24 weeks)
- Assessment of Functional Living Skills (AFLS)(baseline, 16 weeks, 20 weeks, 24 weeks)
- Child and Family Quality of Life (CFQL-2)(baseline, 16, 20, and 24 weeks)