| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
|
|
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. |