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Completed

NCT Number: NCT03286621

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

12 month–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Life Science and Technology, University of Electronic Science and Technology of China

Chengdu, Sichuan, 610054, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of five eye-tracking paradigms

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Electronic Science and Technology of China

Other

Registry information

Official study title

Evaluation of Five Different Eye-tracking Paradigms to Determine Autism in Young Children

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2017
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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