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CTRI Number  CTRI/2021/03/031840 [Registered on: 09/03/2021] Trial Registered Prospectively
Last Modified On: 08/03/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   To identify and detect the early signs of autism in children using eye-movement patterns 
Scientific Title of Study   Eyeing on Autism: The eye gaze-based early detection of Children with Autism Spectrum Disorders 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivani Tiwari 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Room no 409 Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal 576104
Madhav Nagar
Udupi
KARNATAKA
576104
India 
Phone  9986448718  
Fax    
Email  shivani.tiwari@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivani Tiwari 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Room no 409 Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal 576104
Madhav Nagar
Udupi
KARNATAKA
576104
India 
Phone  9986448718  
Fax    
Email  shivani.tiwari@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Shivani Tiwari 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Room no 409 Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal 576104
Madhav Nagar
Udupi
KARNATAKA
576104
India 
Phone  9986448718  
Fax    
Email  shivani.tiwari@manipal.edu  
 
Source of Monetary or Material Support  
Department of Science and Technology DST No: DST/CSRI/2017/398(G)  
 
Primary Sponsor  
Name  Department of Science and Technology 
Address  Technology Bhawan New Mehrauli Road New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivani Tiwari  Kasturba Hospital  Kasturba Hospital, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA 
9986448718

shivani.tiwari@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  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)
 
 
ExclusionCriteria 
Details  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  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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
 
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
 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The researchers plan to publish results from the trial in peer reviewed journals 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background

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

       Eye-tracking has been used widely in the autism research since infants and young children can be assessed easily. It is a potential method of investigating atypical gaze patterns, characteristic of children with ASD. Though, the available evidence largely comes from observational studies often comparing groups of children with ASD and TD controls. Further, the claim that eye-tracking could be a biomarker in early identification of children with ASD is at a hypothetical stage, and not yet tested or verified, except for a few of the longitudinal studies where infants at risk of developing ASD (i.e., siblings of children with a diagnosis of autism) were recruited. In the recent past, Sasson and Elison (2012) have put forth a protocol detailing methodological recommendations for designing research studies in eye tracking in young children with ASD. None of the studies so far have investigated the feasibility of eye gaze as a screening tool 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 are to:

a)    To determine the potential eye gaze parameters that could differentiate children with ASD from typically-developing children

b)    To establish the validity of the relevant eye gaze parameters identified in objective 1 through an epidemiological study

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

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

The second phase of the study intends to establish the validity of the eye gaze parameters identified in Phase1 through an epidemiological longitudinal cohort study. The design of this phase is longitudinal cohort epidemiological study (of length 2-2 ½ years). The sensitive paradigms and stimuli (derived from Phase I) will be administered to all (healthy and high risk) infants and toddlers visiting hospital pediatric centers for vaccination. A follow-up evaluation will be carried out when they reach age three to check for how many develop autism or autism like behaviors. This will help us validate the eye tracking screening protocol.  
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