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

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.

Study Overview

• Status: Completed
• Conditions: Autism
• Intervention / Treatment: Behavioral: Computer Game

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static Eye Gaze Following Task	Eye tracking and accuracy	2 months
Dynamic Eye Gaze Following Task	Eye tracking and accuracy	2 Months
Social/Visual Attention Task	Eye tracking	2 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Responsiveness Scale	Parents completing measure of autism-like behavior in adolescents	2 months
Social Skills Inventory System - Child version	Adolescents completing measure of social skills and problem behaviors in themselves	2 months
Social Skills Inventory System - Adult version	Parents completing measure of social skills and problem behaviors in adolescents	2 months
Treatment as Usual	Parents reporting on social and behavioral treatments adolescents receiving in and out of school	2 months

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Suzy Scherf, PhD, Penn State University

Publications and helpful links

General Publications

• Scherf KS, Griffin JW, Judy B, Whyte EM, Geier CF, Elbich D, Smyth JM. Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial. BMJ Open. 2018 Oct 4;8(9):e023682. doi: 10.1136/bmjopen-2018-023682.

Helpful Links

• Improving sensitivity to eye gaze cues in autism using serious game technology: study protocol for a phase I randomised controlled trial

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 18, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: R61MH110624 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be shared in the NIMH National Data Archive
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)