<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286621</url>
  </required_header>
  <id_info>
    <org_study_id>UESCT_neuSCAN_41</org_study_id>
    <nct_id>NCT03286621</nct_id>
  </id_info>
  <brief_title>Development of Eye-tracking Based Markers for Autism in Young Children</brief_title>
  <official_title>Evaluation of Five Different Eye-tracking Paradigms to Determine Autism in Young Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Electronic Science and Technology of China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Electronic Science and Technology of China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of the present study is to examine eye-tracking based markers for social&#xD;
      processing deficits in children with autism spectrum disorder (ASD). To this end a battery of&#xD;
      five eye-tracking paradigms will be administered to young children with ASD and typically&#xD;
      developing children. To additionally evaluate the specificity of the eye-tracking markers a&#xD;
      group of children with disorders of delayed development other than ASD will be included.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During an initial screening session all participants will undergo the Autism Diagnostic&#xD;
      Observation Schedule (ADOS). ASD-related symptomatology and levels of impairments will be&#xD;
      further characterized using the Social Responsibilities Scale 2 (SRS 2), Caregiver Strain&#xD;
      Questionnaire (CSQ), Aberrant Behavior Checklist (ABC), Social Communication Questionnaire&#xD;
      (SCQ), and Repetitive Behaviour Scale Revised (RBS-R).&#xD;
&#xD;
      Subsequently all participants will be administered the following eye-tracking paradigms: (1)&#xD;
      dynamic social and non-social visual preference paradigm during which dynamic geometric&#xD;
      images (DGI) and dynamic social images (DSI) will be presented, (2) non-biological versus&#xD;
      biological motion paradigm, (3) social attention and sharing of enjoyment paradigm, (4)&#xD;
      preference for real versus schematic emotional face stimuli paradigm during which photographs&#xD;
      of human faces and emoticons will be presented, (5) shared social attention and gaze&#xD;
      direction paradigm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2017</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Global eye-gaze characteristics</measure>
    <time_frame>Single assessment, total duration 20 minutes</time_frame>
    <description>Global eye-gaze patterns between the three groups will be compared to determine ASD specific alterations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feature-specific eye-gaze characteristics</measure>
    <time_frame>Single assessment, total duration 20 minutes</time_frame>
    <description>Localized feature-specific eye-gaze patterns will be compared between the three groups to determine ASD specific alterations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global eye-gaze characteristics and associations with symptom severity</measure>
    <time_frame>Single assessment, total duration 20 minutes</time_frame>
    <description>Associations between global eye-gaze characteristics and severity of ASD symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feature-specific eye-gaze characteristics and associations with symptom severity</measure>
    <time_frame>Single assessment, total duration 20 minutes</time_frame>
    <description>Associations between localized feature-specific eye-gaze patterns and severity of ASD symptoms</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Children with Autism Spectrum Disorder</arm_group_label>
    <description>Children with an Autism Spectrum Disorder according to DSM-5 criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Typically Developing Children</arm_group_label>
    <description>Typically developing children</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children with Delayed Development Disorders</arm_group_label>
    <description>Children with Delayed Developmental Disorders other than ASD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Administration of five eye-tracking paradigms</intervention_name>
    <description>All subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism.</description>
    <arm_group_label>Children with Autism Spectrum Disorder</arm_group_label>
    <arm_group_label>Children with Delayed Development Disorders</arm_group_label>
    <arm_group_label>Typically Developing Children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with ASD according to DSM-5 criteria will be compared with typically developing&#xD;
        children and a group of children with unspecific delayed development disorders.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Exclusion criteria for all participants:&#xD;
&#xD;
          -  visual, auditory or motor impairments&#xD;
&#xD;
          -  use of medication&#xD;
&#xD;
        Inclusion criteria for all participants:&#xD;
&#xD;
          -  written informed consent from parents / caregiver&#xD;
&#xD;
          -  age: 1-10 years&#xD;
&#xD;
        Additional inclusion criterion for the ASD group:&#xD;
&#xD;
        - diagnosis of Autism Spectrum Disorder according to DSM-5&#xD;
&#xD;
        Additional inclusion criteria for typically developing children in the control group:&#xD;
&#xD;
          -  no symptoms of developmental disorders&#xD;
&#xD;
          -  no current or history of psychological disorder&#xD;
&#xD;
        Additional inclusion criterion for the unspecific disorder of delayed development children&#xD;
        in the additional control group:&#xD;
&#xD;
        - disorder of delayed development other than ASD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Kou, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>University of Electronic Science and Technology of China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Life Science and Technology, University of Electronic Science and Technology of China</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610054</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>October 26, 2018</last_update_submitted>
  <last_update_submitted_qc>October 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Electronic Science and Technology of China</investigator_affiliation>
    <investigator_full_name>Keith Kendrick</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>eye tracking</keyword>
  <keyword>visual preference</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286621
org study id: UESCT_neuSCAN_41
nct id: NCT03286621
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Global eye-gaze characteristics
time frame: Single assessment, total duration 20 minutes
description: Global eye-gaze patterns between the three groups will be compared to determine ASD specific alterations
measure: Feature-specific eye-gaze characteristics
time frame: Single assessment, total duration 20 minutes
description: Localized feature-specific eye-gaze patterns will be compared between the three groups to determine ASD specific alterations
measure: Global eye-gaze characteristics and associations with symptom severity
time frame: Single assessment, total duration 20 minutes
description: Associations between global eye-gaze characteristics and severity of ASD symptoms
measure: Feature-specific eye-gaze characteristics and associations with symptom severity
time frame: Single assessment, total duration 20 minutes
description: Associations between localized feature-specific eye-gaze patterns and severity of ASD symptoms
arm group label: Children with Autism Spectrum Disorder
description: Children with an Autism Spectrum Disorder according to DSM-5 criteria
arm group label: Typically Developing Children
description: Typically developing children
arm group label: Children with Delayed Development Disorders
description: Children with Delayed Developmental Disorders other than ASD
intervention type: Other
intervention name: Administration of five eye-tracking paradigms
description: All subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism.
arm group label: Children with Autism Spectrum Disorder
arm group label: Children with Delayed Development Disorders
arm group label: Typically Developing Children
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Juan Kou, MSc
role: Study Chair
affiliation: University of Electronic Science and Technology of China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: University of Electronic Science and Technology of China
investigator full name: Keith Kendrick
investigator title: Professor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No