Expanding Autism Diagnostic Biomarkers to Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Agreement Between Eye-tracking Biomarker Score and Autism Diagnosis
研究概览
简要总结
The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.
详细描述
The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. The investigators will recruit children from Moi Teaching and Referral Hospital (MTRH; Eldoret, Kenya) previously enrolled in the Health Equity Advancing through Learning Health Systems Research (HEAL-R) Autism at MTRH study (IREC/664/2023, approval number 0004633)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 14 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children enrolled in the HEAL-R Autism at MTRH study
- •Children ages 14-72 months
- •Caregivers of children must speak Kiswahili (local language) or English.
排除标准
- •Children not enrolled in the HEAL-R Autism at MTRH study
- •Children younger than 14 months or older than 72 months
- •Caregivers of children do not speak Kiswahili (local language) or English.
研究组 & 干预措施
Children participate in eye-tracking activity
Children enrolled in the HEAL-R Autism at MTRH study will be enrolled into the study. Research participation includes a one-time eye-tracking activity in which the child will view a series of different pictures and movies while their eye movements and pupil diameter are tracked and recorded.
干预措施: Eyelink Portable Duo (Diagnostic Test)
结局指标
主要结局
Agreement Between Eye-tracking Biomarker Score and Autism Diagnosis
时间窗: Day 1
Group (autism presence/absence) differences in the eye-tracking biomarker will be tested to determine whether this metric is predictive of autism diagnosis. Clinical diagnosis was obtained based upon a standardized clinical evaluation in the parent study. The evaluation included: 1) a semi-structured caregiver(s) clinical interview to gather information about developmental history and autism symptoms and 2) a battery of standardized child clinical observational measures. Eye-tracking biomarker will be recorded during a brief one-time research visit. Biomarker (% looking time in non-social region) on a scale for 0 to 100, with greater values reflecting increased attention to non-social information. Cutoff of 40% is used to determine autism likelihood.
次要结局
未报告次要终点
研究者
Rebecca McNally Keehn
Assistant Professor of Pediatrics
Indiana University