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OpenTrials
Completed

NCT Number: NCT02968225

Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Computer Game

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: SAGA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 18, 2016
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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