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

Primary Purpose

Autism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Computer Game
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Pennsylvania State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Computer Game

Waitlist control

Arm Description

All Computer Game participants will complete: online screening Diagnostic and eye-tracking pre-testing 2 month intervention Eye-tracking post-testing

All Treatment as usual control participants will complete: online screening Diagnostic and eye-tracking pre-testing Eye-tracking post-testing

Outcomes

Primary Outcome Measures

Static Eye Gaze Following Task
Eye tracking and accuracy
Dynamic Eye Gaze Following Task
Eye tracking and accuracy
Social/Visual Attention Task
Eye tracking

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2016
Last Updated
March 3, 2021
Sponsor
Penn State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02968225
Brief Title
Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism
Acronym
SAGA
Official Title
Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants randomized into intervention or standard care control conditions
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer Game
Arm Type
Experimental
Arm Description
All Computer Game participants will complete: online screening Diagnostic and eye-tracking pre-testing 2 month intervention Eye-tracking post-testing
Arm Title
Waitlist control
Arm Type
No Intervention
Arm 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(s)
Computer Game
Intervention 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.
Primary Outcome Measure Information:
Title
Static Eye Gaze Following Task
Description
Eye tracking and accuracy
Time Frame
2 months
Title
Dynamic Eye Gaze Following Task
Description
Eye tracking and accuracy
Time Frame
2 Months
Title
Social/Visual Attention Task
Description
Eye tracking
Time Frame
2 Months
Secondary Outcome Measure Information:
Title
Social Responsiveness Scale
Description
Parents completing measure of autism-like behavior in adolescents
Time Frame
2 months
Title
Social Skills Inventory System - Child version
Description
Adolescents completing measure of social skills and problem behaviors in themselves
Time Frame
2 months
Title
Social Skills Inventory System - Adult version
Description
Parents completing measure of social skills and problem behaviors in adolescents
Time Frame
2 months
Title
Treatment as Usual
Description
Parents reporting on social and behavioral treatments adolescents receiving in and out of school
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzy Scherf, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be shared in the NIMH National Data Archive
Citations:
PubMed Identifier
30287612
Citation
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.
Results Reference
derived
Links:
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

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

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