<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/NCT02968225</url>
  </required_header>
  <id_info>
    <org_study_id>R61MH110624</org_study_id>
    <nct_id>NCT02968225</nct_id>
  </id_info>
  <brief_title>Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism</brief_title>
  <acronym>SAGA</acronym>
  <official_title>Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Penn State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that this serious game (designed to provide a learning&#xD;
      environment that maximizes opportunities for adolescents with autism to discover the&#xD;
      functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to&#xD;
      identify gazed-at objects, and will also lead to increased social attention to faces in&#xD;
      adolescents with autism. The investigators will test this hypothesis in a small-scale&#xD;
      exploratory randomized control trial that will include both behavioral and eye tracking&#xD;
      outcome measures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants randomized into intervention or standard care control conditions</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Given the design of the study, parents and adolescents will know the condition to which they have been assigned. However, researchers involved in data collection will be blinded from condition assignment during the pre-intervention data collection session as these data will be collected prior to randomization. Also, the research team is not involved in the randomization process. The research team members who are involved in ensuring the fidelity of the intervention are not involved in data collection procedures. Although we will attempt to limit unblinding, it is not possible for researchers involved in data collection to be completely blinded to the assignment of participant condition at the post-intervention visit as we cannot prohibit participants from talking to researchers about their experience in the study. Importantly, the primary outcome measures are believed to be robust to investigator bias.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Static Eye Gaze Following Task</measure>
    <time_frame>2 months</time_frame>
    <description>Eye tracking and accuracy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dynamic Eye Gaze Following Task</measure>
    <time_frame>2 Months</time_frame>
    <description>Eye tracking and accuracy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social/Visual Attention Task</measure>
    <time_frame>2 Months</time_frame>
    <description>Eye tracking</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Social Responsiveness Scale</measure>
    <time_frame>2 months</time_frame>
    <description>Parents completing measure of autism-like behavior in adolescents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Skills Inventory System - Child version</measure>
    <time_frame>2 months</time_frame>
    <description>Adolescents completing measure of social skills and problem behaviors in themselves</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Skills Inventory System - Adult version</measure>
    <time_frame>2 months</time_frame>
    <description>Parents completing measure of social skills and problem behaviors in adolescents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment as Usual</measure>
    <time_frame>2 months</time_frame>
    <description>Parents reporting on social and behavioral treatments adolescents receiving in and out of school</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Computer Game</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All Computer Game participants will complete:&#xD;
online screening&#xD;
Diagnostic and eye-tracking pre-testing&#xD;
2 month intervention&#xD;
Eye-tracking post-testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All Treatment as usual control participants will complete:&#xD;
online screening&#xD;
Diagnostic and eye-tracking pre-testing&#xD;
Eye-tracking post-testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer Game</intervention_name>
    <description>The game involves viewing subtle nonverbal behaviors of game characters for the purpose of executing their own goal-directed behavior in the game related to solving various crimes. The learning involves interpreting nonverbal cues on the animated characters, such as pointing, head turns, eye gaze cues.</description>
    <arm_group_label>Computer Game</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. parent/caregiver of an adolescent with a diagnosis of ASD,&#xD;
&#xD;
          2. parent/caregiver and adolescent with ASD both native English speakers,&#xD;
&#xD;
          3. adolescent with ASD aged between 10-18 years at enrollment,&#xD;
&#xD;
          4. adolescent has normal vision and hearing with correction as indicated by parent&#xD;
             report,&#xD;
&#xD;
          5. adolescent is able to use a computer for the purposes of game play,&#xD;
&#xD;
          6. adolescent scores &gt; 80% correct (i.e., 0.5 SD less than M of TD adolescents) on online&#xD;
             eye gaze screening task,&#xD;
&#xD;
          7. ASD diagnosis of adolescent confirmed in lab via the Autism Diagnostic Observation&#xD;
             Schedule,&#xD;
&#xD;
          8. Full Scale IQ of adolescent determined to be between 70-130 on the Kaufman Brief&#xD;
             Intelligence Test,&#xD;
&#xD;
          9. reading ability of adolescent determined to be at least a second grade level as&#xD;
             assessed by the Oral and Written Language Scales,&#xD;
&#xD;
         10. adolescent is capable of cooperating with testing,&#xD;
&#xD;
         11. parent/caregiver and adolescent both consent/assent to participate in the research.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. adolescent has had seizures within the previous two years,&#xD;
&#xD;
          2. family lacks stable home internet,&#xD;
&#xD;
          3. parent or adolescent refuses to consent/assent to take part in the research,&#xD;
&#xD;
          4. adolescent is 18 and has a legal guardian, prohibiting him/her from legally&#xD;
             consenting, or&#xD;
&#xD;
          5. adolescent is 18 and cannot understand the consent (i.e., fails consent quiz).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzy Scherf, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennsylvania State University</name>
      <address>
        <city>University Park</city>
        <state>Pennsylvania</state>
        <zip>16802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://bmjopen.bmj.com/content/bmjopen/8/9/e023682.full.pdf</url>
    <description>Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Penn State University</investigator_affiliation>
    <investigator_full_name>K. Suzanne Scherf</investigator_full_name>
    <investigator_title>Associate Professor of Psychology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data will be shared in the NIMH National Data Archive</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </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/NCT02968225
org study id: R61MH110624
nct id: NCT02968225
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators hypothesize that this serious game (designed to provide a learning
      environment that maximizes opportunities for adolescents with autism to discover the
      functional utility of eye gaze) will improve sensitivity to eye gaze cues, specifically to
      identify gazed-at objects, and will also lead to increased social attention to faces in
      adolescents with autism. The investigators will test this hypothesis in a small-scale
      exploratory randomized control trial that will include both behavioral and eye tracking
      outcome measures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants randomized into intervention or standard care control conditions
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Given the design of the study, parents and adolescents will know the condition to which they have been assigned. However, researchers involved in data collection will be blinded from condition assignment during the pre-intervention data collection session as these data will be collected prior to randomization. Also, the research team is not involved in the randomization process. The research team members who are involved in ensuring the fidelity of the intervention are not involved in data collection procedures. Although we will attempt to limit unblinding, it is not possible for researchers involved in data collection to be completely blinded to the assignment of participant condition at the post-intervention visit as we cannot prohibit participants from talking to researchers about their experience in the study. Importantly, the primary outcome measures are believed to be robust to investigator bias.
measure: Static Eye Gaze Following Task
time frame: 2 months
description: Eye tracking and accuracy
measure: Dynamic Eye Gaze Following Task
time frame: 2 Months
description: Eye tracking and accuracy
measure: Social/Visual Attention Task
time frame: 2 Months
description: Eye tracking
measure: Social Responsiveness Scale
time frame: 2 months
description: Parents completing measure of autism-like behavior in adolescents
measure: Social Skills Inventory System - Child version
time frame: 2 months
description: Adolescents completing measure of social skills and problem behaviors in themselves
measure: Social Skills Inventory System - Adult version
time frame: 2 months
description: Parents completing measure of social skills and problem behaviors in adolescents
measure: Treatment as Usual
time frame: 2 months
description: Parents reporting on social and behavioral treatments adolescents receiving in and out of school
arm group label: Computer Game
arm group type: Experimental
description: All Computer Game participants will complete:
online screening
Diagnostic and eye-tracking pre-testing
2 month intervention
Eye-tracking post-testing
arm group label: Waitlist control
arm group type: No Intervention
description: All Treatment as usual control participants will complete:
online screening
Diagnostic and eye-tracking pre-testing
Eye-tracking post-testing
intervention type: Behavioral
intervention name: Computer Game
description: The game involves viewing subtle nonverbal behaviors of game characters for the purpose of executing their own goal-directed behavior in the game related to solving various crimes. The learning involves interpreting nonverbal cues on the animated characters, such as pointing, head turns, eye gaze cues.
arm group label: Computer Game
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Suzy Scherf, PhD
role: Principal Investigator
affiliation: Penn State University
facility: 
country: United States
url: https://bmjopen.bmj.com/content/bmjopen/8/9/e023682.full.pdf
description: Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial
responsible party type: Principal Investigator
investigator affiliation: Penn State University
investigator full name: K. Suzanne Scherf
investigator title: Associate Professor of Psychology
mesh term: Autistic Disorder
sharing ipd: Yes
ipd description: The data will be shared in the NIMH National Data Archive
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)