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Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism (SAGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02968225
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
K. Suzanne Scherf, Penn State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Behavioral: Computer Game Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants randomized into intervention or standard care control conditions
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.
Primary Purpose: Treatment
Official Title: Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism
Study Start Date : August 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Computer Game

All Computer Game participants will complete:

  • online screening
  • Diagnostic and eye-tracking pre-testing
  • 2 month intervention
  • Eye-tracking post-testing
Behavioral: Computer Game
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.

No Intervention: Waitlist control

All Treatment as usual control participants will complete:

  • online screening
  • Diagnostic and eye-tracking pre-testing
  • Eye-tracking post-testing



Primary Outcome Measures :
  1. Static Eye Gaze Following Task [ Time Frame: 2 months ]
    Eye tracking and accuracy

  2. Dynamic Eye Gaze Following Task [ Time Frame: 2 Months ]
    Eye tracking and accuracy

  3. Social/Visual Attention Task [ Time Frame: 2 Months ]
    Eye tracking


Secondary Outcome Measures :
  1. Social Responsiveness Scale [ Time Frame: 2 months ]
    Parents completing measure of autism-like behavior in adolescents

  2. Social Skills Inventory System - Child version [ Time Frame: 2 months ]
    Adolescents completing measure of social skills and problem behaviors in themselves

  3. Social Skills Inventory System - Adult version [ Time Frame: 2 months ]
    Parents completing measure of social skills and problem behaviors in adolescents

  4. Treatment as Usual [ Time Frame: 2 months ]
    Parents reporting on social and behavioral treatments adolescents receiving in and out of school



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. parent/caregiver of an adolescent with a diagnosis of ASD,
  2. parent/caregiver and adolescent with ASD both native English speakers,
  3. adolescent with ASD aged between 10-18 years at enrollment,
  4. adolescent has normal vision and hearing with correction as indicated by parent report,
  5. adolescent is able to use a computer for the purposes of game play,
  6. adolescent scores > 80% correct (i.e., 0.5 SD less than M of TD adolescents) on online eye gaze screening task,
  7. ASD diagnosis of adolescent confirmed in lab via the Autism Diagnostic Observation Schedule,
  8. Full Scale IQ of adolescent determined to be between 70-130 on the Kaufman Brief Intelligence Test,
  9. reading ability of adolescent determined to be at least a second grade level as assessed by the Oral and Written Language Scales,
  10. adolescent is capable of cooperating with testing,
  11. parent/caregiver and adolescent both consent/assent to participate in the research.

Exclusion Criteria

  1. adolescent has had seizures within the previous two years,
  2. family lacks stable home internet,
  3. parent or adolescent refuses to consent/assent to take part in the research,
  4. adolescent is 18 and has a legal guardian, prohibiting him/her from legally consenting, or
  5. adolescent is 18 and cannot understand the consent (i.e., fails consent quiz).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968225


Locations
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United States, Pennsylvania
Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Penn State University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Suzy Scherf, PhD Penn State University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: K. Suzanne Scherf, Associate Professor of Psychology, Penn State University
ClinicalTrials.gov Identifier: NCT02968225    
Other Study ID Numbers: R61MH110624 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared in the NIMH National Data Archive
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders