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CTRI Number  CTRI/2024/09/074257 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Eye gaze screening tool for autism detection 
Scientific Title of Study   Validation of an eye gaze screening protocol for early identification of autism 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivani Tiwari 
Designation  Associate Professor 
Affiliation  MCHP ,MAHE Manipal 
Address  Department of Speech and Hearing , Manipal College of Health Professions, Manipal University,Manipal-576104, Karnataka,India

Udupi
KARNATAKA
576104
India 
Phone  9986448718  
Fax    
Email  shivani.tiwari@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Shivani Tiwari 
Designation  Associate Professor 
Affiliation  MCHP ,MAHE Manipal 
Address  Department of Speech and Hearing , Manipal College of Health Professions, Manipal University,Manipal-576104, Karnataka,India


KARNATAKA
576104
India 
Phone  9986448718  
Fax    
Email  shivani.tiwari@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Shivani Tiwari 
Designation  Associate Professor 
Affiliation  MCHP ,MAHE Manipal 
Address  Department of Speech and Hearing , Manipal College of Health Professions, Manipal University,Manipal-576104, Karnataka,India


KARNATAKA
576104
India 
Phone  9986448718  
Fax    
Email  shivani.tiwari@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O.Box No.4911 Ansari Nagar,New Delhi-110029,India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Self  Dept. of Speech and Hearing, MCHP, MAHE, Manipal  
 
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 Manipal  Madhavnagar, Manipal
Udupi
KARNATAKA 
09986448718

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-1  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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  9.00 Month(s)
Age To  30.00 Month(s)
Gender  Both 
Details  1. Infants between 9 – 30 months of age
2. Siblings of children with ASD
3. Infants with high-risk factors
4. Normal vision and hearing 
 
ExclusionCriteria 
Details  1. Uncorrected vision
2. Any other associated problems
3. Delayed motor milestones 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The validity of the eye gaze-based screening protocol will be measured by obtaining the proportion of
children who develop and do not develop ASD at the follow-up visit out of infants who were screened
(including those who passed and failed) to derive the sensitivity and specificity values. 
week 1 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   07/10/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
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.
 
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