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临床试验/NCT06471504
NCT06471504招募中不适用

Use of Eye Tracking to Aid in Autism Risk Detection

Indiana University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Agreement between eye-tracking biomarker score and 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 ages 12-48 months. We will recruit children from Riley Hospital for Children at Indiana University Health clinics to determine whether these measures may help determine autism risk.

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
12 Months 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Young children ages 12-48 months scheduled for health care visits at Riley Hospital for Children at Indiana University Health clinics (e.g., Pediatric Care Center clinics).
  • Children must have English- or Spanish-speaking caregivers.
  • Children must have a legal guardian that is able to provide consent.

排除标准

  • Child is younger than 12 months or older than 48 months.
  • Child's caregiver(s) is not English- or Spanish-speaking.

研究组 & 干预措施

Children Undergoing Developmental Evaluation

Experimental

Children undergoing a standard of care developmental evaluation will be enrolled into the study. After the completion of the developmental evaluation, 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 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 diagnosis

时间窗: Day 1

The composite eye-tracking biomarker score, a consolidated measure based on eye-tracking indices that predict autism outcome, will be compared to the categorical autism diagnosis (autism presence/absence). Clinical diagnosis is obtained based upon a standard clinical evaluation conducted by an expert clinical psychologist. The evaluation will include 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. The evaluation will be conducted over a one-time 2-hour clinical autism evaluation. Eye-tracking will be recorded immediately following the clinical evaluation for a period of up to 15 minutes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca McNally Keehn

Assistant Professor of Pediatrics

Indiana University

研究点 (2)

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