- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03286621
Development of Eye-tracking Based Markers for Autism in Young Children
Evaluation of Five Different Eye-tracking Paradigms to Determine Autism in Young Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During an initial screening session all participants will undergo the Autism Diagnostic Observation Schedule (ADOS). ASD-related symptomatology and levels of impairments will be further characterized using the Social Responsibilities Scale 2 (SRS 2), Caregiver Strain Questionnaire (CSQ), Aberrant Behavior Checklist (ABC), Social Communication Questionnaire (SCQ), and Repetitive Behaviour Scale Revised (RBS-R).
Subsequently all participants will be administered the following eye-tracking paradigms: (1) dynamic social and non-social visual preference paradigm during which dynamic geometric images (DGI) and dynamic social images (DSI) will be presented, (2) non-biological versus biological motion paradigm, (3) social attention and sharing of enjoyment paradigm, (4) preference for real versus schematic emotional face stimuli paradigm during which photographs of human faces and emoticons will be presented, (5) shared social attention and gaze direction paradigm.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Sichuan
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Chengdu, Sichuan, China, 610054
- School of Life Science and Technology, University of Electronic Science and Technology of China
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Exclusion criteria for all participants:
- visual, auditory or motor impairments
- use of medication
Inclusion criteria for all participants:
- written informed consent from parents / caregiver
- age: 1-10 years
Additional inclusion criterion for the ASD group:
- diagnosis of Autism Spectrum Disorder according to DSM-5
Additional inclusion criteria for typically developing children in the control group:
- no symptoms of developmental disorders
- no current or history of psychological disorder
Additional inclusion criterion for the unspecific disorder of delayed development children in the additional control group:
- disorder of delayed development other than ASD
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children with Autism Spectrum Disorder
Children with an Autism Spectrum Disorder according to DSM-5 criteria
|
All subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism.
|
Typically Developing Children
Typically developing children
|
All subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism.
|
Children with Delayed Development Disorders
Children with Delayed Developmental Disorders other than ASD
|
All subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global eye-gaze characteristics
Time Frame: Single assessment, total duration 20 minutes
|
Global eye-gaze patterns between the three groups will be compared to determine ASD specific alterations
|
Single assessment, total duration 20 minutes
|
Feature-specific eye-gaze characteristics
Time Frame: Single assessment, total duration 20 minutes
|
Localized feature-specific eye-gaze patterns will be compared between the three groups to determine ASD specific alterations
|
Single assessment, total duration 20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global eye-gaze characteristics and associations with symptom severity
Time Frame: Single assessment, total duration 20 minutes
|
Associations between global eye-gaze characteristics and severity of ASD symptoms
|
Single assessment, total duration 20 minutes
|
Feature-specific eye-gaze characteristics and associations with symptom severity
Time Frame: Single assessment, total duration 20 minutes
|
Associations between localized feature-specific eye-gaze patterns and severity of ASD symptoms
|
Single assessment, total duration 20 minutes
|
Collaborators and Investigators
Investigators
- Study Chair: Juan Kou, MSc, University of Electronic Science and Technology of China
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESCT_neuSCAN_41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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