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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03286621
Other study ID # UESCT_neuSCAN_41
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 9, 2017
Est. completion date February 28, 2018

Study information

Verified date October 2018
Source University of Electronic Science and Technology of China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date February 28, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China School of Life Science and Technology, University of Electronic Science and Technology of China Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global eye-gaze characteristics Global eye-gaze patterns between the three groups will be compared to determine ASD specific alterations Single assessment, total duration 20 minutes
Primary Feature-specific eye-gaze characteristics 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 Global eye-gaze characteristics and associations with symptom severity Associations between global eye-gaze characteristics and severity of ASD symptoms Single assessment, total duration 20 minutes
Secondary Feature-specific eye-gaze characteristics and associations with symptom severity Associations between localized feature-specific eye-gaze patterns and severity of ASD symptoms Single assessment, total duration 20 minutes
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