Autism Spectrum DisorderNCT03286621
Development of Eye-tracking Based Markers for Autism in Young Children
An observational study of Autism Spectrum Disorder, run by University of Electronic Science and Technology of China at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 12 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Administration of five eye-tracking paradigms
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2017to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- visual, auditory or motor impairments
- use of medication
Trial locations and contacts
1 site in 1 country.
China1 site
School of Life Science and Technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
About this study
Official title: Evaluation of Five Different Eye-tracking Paradigms to Determine 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Administration of five eye-tracking paradigms
- Keywords
- eye tracking, visual preference
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of five eye-tracking paradigmsOther
All subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism.
| Study group | Role | What they receive |
|---|---|---|
| Children with Autism Spectrum Disorder | Children with an Autism Spectrum Disorder according to DSM-5 criteria Receives: Other: Administration of five eye-tracking paradigms | |
| Typically Developing Children | Typically developing children Receives: Other: Administration of five eye-tracking paradigms | |
| Children with Delayed Development Disorders | Children with Delayed Developmental Disorders other than ASD Receives: Other: Administration of five eye-tracking paradigms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global eye-gaze characteristics
Global eye-gaze patterns between the three groups will be compared to determine ASD specific alterations
Measured: Single assessment, total duration 20 minutes
Feature-specific eye-gaze characteristics
Localized feature-specific eye-gaze patterns will be compared between the three groups to determine ASD specific alterations
Measured: Single assessment, total duration 20 minutes
Secondary outcomes (2)
Global eye-gaze characteristics and associations with symptom severity
Associations between global eye-gaze characteristics and severity of ASD symptoms
Measured: Single assessment, total duration 20 minutes
Feature-specific eye-gaze characteristics and associations with symptom severity
Associations between localized feature-specific eye-gaze patterns and severity of ASD symptoms
Measured: Single assessment, total duration 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start9 Sep 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
- Investigators
- Juan Kou, MSc, Study chair, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286621
- Sponsor's protocol ID
- UESCT_neuSCAN_41
- Status last verified
- Oct 2018
- First submitted
- 14 Sep 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31369217
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Five Different Eye-tracking Paradigms to Determine Autism in Young Children
- ClinicalTrials.gov ID
- NCT03286621
- Acronym / sponsor ID
- UESCT_neuSCAN_41
- Conditions
- Autism Spectrum Disorder
- Keywords
- eye tracking, visual preference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with Autism Spectrum Disorder | – | Other: Administration of five eye-tracking paradigmsChildren with an Autism Spectrum Disorder according to DSM-5 criteria |
| Typically Developing Children | – | Other: Administration of five eye-tracking paradigmsTypically developing children |
| Children with Delayed Development Disorders | – | Other: Administration of five eye-tracking paradigmsChildren with Delayed Developmental Disorders other than ASD |
Who may qualify
- Ages
- 12 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (9 listed)
- written informed consent from parents / caregiver
- age: 1-10 years
- diagnosis of Autism Spectrum Disorder according to DSM-5
- no symptoms of developmental disorders
- no current or history of psychological disorder
Key exclusion criteria (2 listed)
- visual, auditory or motor impairments
- use of medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of five eye-tracking paradigmsAll subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism. | Other | Children with Autism Spectrum Disorder, Children with Delayed Development Disorders, Typically Developing Children |
Primary outcome
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
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
2 secondary outcomes
Global eye-gaze characteristics and associations with symptom severity
Time frame: Single assessment, total duration 20 minutes
Feature-specific eye-gaze characteristics and associations with symptom severity
Time frame: Single assessment, total duration 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 31369217Kou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Kou, MSc study chair
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global eye-gaze characteristics (time frame: Single assessment, total duration 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03286621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018; AzTrials last refreshed its copy on 1 Nov 2026.