Clinical trial NCT03286621: Development of Eye-tracking Based Markers for Autism in Young Children
Official title: Evaluation of Five Different Eye-tracking Paradigms to Determine Autism in Young Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: eye tracking
visual preference
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Global eye-gaze characteristics
timeFrame: Single assessment, total duration 20 minutes
measure: Feature-specific eye-gaze characteristics
timeFrame: Single assessment, total duration 20 minutes
Secondary outcomes:
measure: Global eye-gaze characteristics and associations with symptom severity
timeFrame: Single assessment, total duration 20 minutes
measure: Feature-specific eye-gaze characteristics and associations with symptom severity
timeFrame: Single assessment, total duration 20 minutes
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Juan Kou, MSc
role: STUDY_CHAIR
References:
citation: Kou J, Le J, Fu M, Lan C, Chen Z, Li Q, Zhao W, Xu L, Becker B, Kendrick KM. Comparison of three different eye-tracking tasks for distinguishing autistic from typically developing children and autistic symptom severity. Autism Res. 2019 Oct;12(10):1529-1540. doi: 10.1002/aur.2174. Epub 2019 Aug 1.