A Randomized Controlled Phase II Study to Assess the Efficacy of Floreo VR Building Social Connections vs. Active VR Exposure Control as Treatment for Social Skills in Autistic Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Floreo, Inc.
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Autism Impact Measure (AIM) Assessment
研究概览
简要总结
A Randomized Controlled Phase II study to assess the efficacy of Floreo VR (Virtual reality) Building Social Connections as treatment for social skills in children with Autism Spectrum Disorder (ASD)
详细描述
In this randomized controlled phase II study, 30 eligible subjects aged 4-10 years old with documented ASD diagnoses will be enrolled and randomized in a 1:1 ratio intervention vs control group.
The Floreo VR Building Social Connections intervention is designed to be administered for 12 weeks, with three treatment visits per week, for a total of 36 treatment visits.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subjects and their parents/caregivers will be blinded to whether they are receiving Floreo VR therapy vs active VR exposure control. Research staff administering the therapy or control will not be blinded to the therapy; however, the clinicians doing pre/post assessments will be blinded.
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 4 years to 10 years 11 months of age (up to 11th birthday at randomization).
- •Patients or legally authorized representatives must provide written informed consent and be willing and able to comply with study procedures. Participants must provide informed assent as clinically appropriate.
- •A diagnosis of autism spectrum disorder on the basis of the clinical judgement of a qualified clinician according to DSM-5 criteria, supported by either the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
- •Participants must receive ABA therapy at Cortica, with scheduled ABA sessions in clinic at least 3 times per week.
- •Participants must be able to tolerate VR therapy in the judgement of parent or caregiver and study staff
排除标准
- •A history of photosensitive epilepsy, or photoparoxysmal response on electroencephalogram (EEG)
- •Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome), not adequately controlled
- •History of balance disorder including vertigo, motion sensitivity, or balance disorder
- •Primary sensory impairment (blindness, deafness)
- •Motor disorder that would interfere with VR engagement
结局指标
主要结局
Autism Impact Measure (AIM) Assessment
时间窗: The AIM takes approximately 30 minutes to complete.
The AIM is a 25-item parent questionnaire targeting sensitivity to change of core ASD symptoms. The questionnaire uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact). The items cover distinct sub-domains of ASD symptoms including Repetitive Behavior, Atypical Behavior, Social Reciprocity, and Peer Interaction. A composite score is also calculated.
次要结局
- CARS-2(The CARS-3 takes approximately 5-10 minutes to complete after the information needed to make the ratings is collected)