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临床试验/CTRI/2021/03/031840
CTRI/2021/03/031840尚未招募1 期

Eyeing on Autism: The eye gaze-based early detection of Children with Autism Spectrum Disorders

Department of Science and Technology1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年3月15日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
1)Interest area dwell time

研究概览

简要总结

Background

Autism Spectrum Disorder (ASD) is a neurodevelopmentaldisorder characterized by core deficits in areas such as social interaction,non-verbal communication and restricted/repetitive behaviours (AmericanPsychiatric Association, 2013). A large proportion of CwASD have limitedpre-linguistic skills, such as eye-contact and joint attention, which arefoundational for the development of verbal language (Bakeman & Adamson,1984).

Eye-tracking has been used widely in theautism research since infants and young children can be assessed easily. It isa potential method of investigating atypical gaze patterns, characteristic ofchildren with ASD. Though, the available evidence largely comes fromobservational studies often comparing groups of children with ASD and TDcontrols. Further, the claim that eye-tracking could be a biomarker in earlyidentification of children with ASD is at a hypothetical stage, and not yettested or verified, except for a few of the longitudinal studies where infantsat risk of developing ASD (i.e., siblings of children with a diagnosis ofautism) were recruited. In the recent past, Sasson and Elison (2012) have putforth a protocol detailing methodological recommendations for designingresearch studies in eye tracking in young children with ASD. None of thestudies so far have investigated the feasibility of eye gaze as a screeningtool for early identification of children with ASD in an epidemiological,population-based design (including all children at risk and healthy controls).

The aim and objectives of this investigation areto:

a)   Todetermine the potential eye gaze parameters that could differentiate childrenwith ASD from typically-developing children

b)   Toestablish the validity of the relevant eye gaze parameters identified inobjective 1 through an epidemiological study

The proposedstudy aims to develop an eye gaze-based early screening protocol for childrenwith ASD. The proposed study will be carried out in two phases.

The first phasewill identify the eye gaze parameters that differentiate children with ASD fromtypically-developing (TD) children during social-communicative context, using aseries of available paradigms (from literature). The design for the first phaseof the study would be cross-sectional observational case control study.

The second phase ofthe study intends to establish the validity of the eye gaze parametersidentified in Phase1 through an epidemiological longitudinal cohort study. Thedesign of this phase is longitudinal cohort epidemiological study (of length2-2 ½ years). The sensitive paradigms and stimuli (derived from Phase I) willbe administered to all (healthy and high risk) infants and toddlers visitinghospital pediatric centers for vaccination. A follow-up evaluation will becarried out when they reach age three to check for how many develop autism orautism like behaviors. This will help us validate the eye tracking screeningprotocol.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • 1.Children with a diagnosis of ASD (The diagnosis of ASD would be established base on DSM V criteria and Modified Checklist for Autism (M-CHAT), upon administration of Childhood Autism Rating Scale (CARS).
  • 2.Normal vision and hearing (based on electrophysiological assessment).

排除标准

  • 1.High risk factors 2.Siblings with Autism or any other speech and language disorder 3.History of delayed developmental milestones 4.Any neurological issues or history.

结局指标

主要结局

1)Interest area dwell time

时间窗: 1)Interest area dwell time | 2)Interest area dwell time percentage | 3)Interest area fixation percentage | 4)Interest area fixation count | 5)Interest area first fixation duration | 6)Trial dwell time | 7)Trial fixation count | 8)Trial Interest area count

2)Interest area dwell time percentage

时间窗: 1)Interest area dwell time | 2)Interest area dwell time percentage | 3)Interest area fixation percentage | 4)Interest area fixation count | 5)Interest area first fixation duration | 6)Trial dwell time | 7)Trial fixation count | 8)Trial Interest area count

3)Interest area fixation percentage

时间窗: 1)Interest area dwell time | 2)Interest area dwell time percentage | 3)Interest area fixation percentage | 4)Interest area fixation count | 5)Interest area first fixation duration | 6)Trial dwell time | 7)Trial fixation count | 8)Trial Interest area count

8)Trial Interest area count

时间窗: 1)Interest area dwell time | 2)Interest area dwell time percentage | 3)Interest area fixation percentage | 4)Interest area fixation count | 5)Interest area first fixation duration | 6)Trial dwell time | 7)Trial fixation count | 8)Trial Interest area count

4)Interest area fixation count

时间窗: 1)Interest area dwell time | 2)Interest area dwell time percentage | 3)Interest area fixation percentage | 4)Interest area fixation count | 5)Interest area first fixation duration | 6)Trial dwell time | 7)Trial fixation count | 8)Trial Interest area count

5)Interest area first fixation duration

时间窗: 1)Interest area dwell time | 2)Interest area dwell time percentage | 3)Interest area fixation percentage | 4)Interest area fixation count | 5)Interest area first fixation duration | 6)Trial dwell time | 7)Trial fixation count | 8)Trial Interest area count

6)Trial dwell time

时间窗: 1)Interest area dwell time | 2)Interest area dwell time percentage | 3)Interest area fixation percentage | 4)Interest area fixation count | 5)Interest area first fixation duration | 6)Trial dwell time | 7)Trial fixation count | 8)Trial Interest area count

7)Trial fixation count

时间窗: 1)Interest area dwell time | 2)Interest area dwell time percentage | 3)Interest area fixation percentage | 4)Interest area fixation count | 5)Interest area first fixation duration | 6)Trial dwell time | 7)Trial fixation count | 8)Trial Interest area count

次要结局

  • Sensitivity and specificity of the eye gaze detection paradigm(Phase II during follow up after 2 to 21/2 years of first assessment using eye gaze detection paradigm)

研究者

申办方类型
Government funding agency

研究点 (1)

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