跳至主要内容
临床试验/CTRI/2024/09/074257
CTRI/2024/09/074257尚未招募不适用

Validation of an eye gaze screening protocol for early identification of autism

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
The validity of the eye gaze-based screening protocol will be measured by obtaining the proportion of

研究概览

简要总结

Early identification of ASD is, at present, a global challenge. Several factors like increased behavioral variability at a young age, heterogenic profiles of the ASD as well as the overlapping features of this condition with other developmental disorders complicate the early detection of children with ASD. While several biomarkers of ASD have been identified and proposed in the recent years, many of these face criticism because of time constraints, cost factors, and lack of replicability. Of late, the eye-tracking technology has provided the opportunity to detect even subtle aberrations in eye gaze during social interaction in young children with ASD. Being a non-invasive technique, the eye-tracking and gaze monitoring in young children are advantageous over several other methods like neuroimaging and biochemical investigations. In the recent years, several researchers have proposed eye-tracking paradigms and tasks to assess gaze monitoring in children with ASD using a range of stimuli. However, most of such evidence is drawn from only observational studies that compare children with ASD and typically-developing (TD) controls. That is, these tasks and paradigms are not validated across various settings and age ranges, thereby limiting their application in screening and early identification of children with ASD. Hence, it is necessary to examine various eye-tracking paradigms and tasks proposed for children with ASD to identify the valid paradigms and tasks for the early identification of ASD.

The proposed project is expected to validate an eye gaze based screening protocol for early detection of children with ASD that may provide an easy and quick screening test that can be used by health providers like pediatricians. This would help in early identification, monitoring, and intervention of children with ASD, thereby improving the outcome and quality of life of families and children with ASD. This study would be the first of its kind in the Indian context and would be relevant given the country population and rising incidence of ASD.

研究设计

研究类型
Observational

入排标准

年龄范围
9.00 Month(s) 至 30.00 Month(s)(—)
性别
All

入选标准

  • Infants between 9 – 30 months of age
  • Siblings of children with ASD
  • Normal vision and hearing.

排除标准

  • Uncorrected vision
  • Any other associated problems
  • Delayed motor milestones.

结局指标

主要结局

The validity of the eye gaze-based screening protocol will be measured by obtaining the proportion of

时间窗: week 1

children who develop and do not develop ASD at the follow-up visit out of infants who were screened

时间窗: week 1

(including those who passed and failed) to derive the sensitivity and specificity values.

时间窗: week 1

次要结局

未报告次要终点

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Shivani Tiwari

MCHP ,MAHE Manipal

研究点 (1)

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