NCT03286621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

September 14, 2017

Last Update Submit

October 26, 2018

Conditions

Keywords

eye trackingvisual preference

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Global eye-gaze characteristics and associations with symptom severity

    Single assessment, total duration 20 minutes

  • Feature-specific eye-gaze characteristics and associations with symptom severity

    Single assessment, total duration 20 minutes

Study Arms (3)

Children with Autism Spectrum Disorder

Children with an Autism Spectrum Disorder according to DSM-5 criteria

Other: Administration of five eye-tracking paradigms

Typically Developing Children

Typically developing children

Other: Administration of five eye-tracking paradigms

Children with Delayed Development Disorders

Children with Delayed Developmental Disorders other than ASD

Other: Administration of five eye-tracking paradigms

Interventions

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

Children with Autism Spectrum DisorderChildren with Delayed Development DisordersTypically Developing Children

Eligibility Criteria

Age12 Months - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may not qualify if:

  • visual, auditory or motor impairments
  • use of medication
  • 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
  • \- disorder of delayed development other than ASD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chengdu, Sichuan, 610054, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Juan Kou, MSc

    University of Electronic Science and Technology of China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

September 9, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

October 29, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations