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Development of Eye-tracking Based Markers for Autism in Young Children

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ClinicalTrials.gov Identifier: NCT03286621
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Keith Kendrick, University of Electronic Science and Technology of China

Brief Summary:
The main aim of the present study is to examine eye-tracking based markers for social processing deficits in children with autism spectrum disorder (ASD). To this end a battery of five eye-tracking paradigms will be administered to young children with ASD and typically developing children. To additionally evaluate the specificity of the eye-tracking markers a group of children with disorders of delayed development other than ASD will be included.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Other: Administration of five eye-tracking paradigms

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 : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Five Different Eye-tracking Paradigms to Determine Autism in Young Children
Actual Study Start Date : September 9, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Children with Autism Spectrum Disorder
Children with an Autism Spectrum Disorder according to DSM-5 criteria
Other: Administration of five eye-tracking paradigms
All subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism.

Typically Developing Children
Typically developing children
Other: Administration of five eye-tracking paradigms
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
Other: Administration of five eye-tracking paradigms
All subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   12 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children with ASD according to DSM-5 criteria will be compared with typically developing children and a group of children with unspecific delayed development disorders.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286621


Locations
China, Sichuan
School of Life Science and Technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, China, 610054
Sponsors and Collaborators
University of Electronic Science and Technology of China
Investigators
Study Chair: Juan Kou, MSc University of Electronic Science and Technology of China

Responsible Party: Keith Kendrick, Professor, University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier: NCT03286621     History of Changes
Other Study ID Numbers: UESCT_neuSCAN_41
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Keith Kendrick, University of Electronic Science and Technology of China:
eye tracking
visual preference

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders