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

Autism Clinical Trial

— SAGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968225
• Other study ID #: R61MH110624
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: October 2018

Study information

• Verified date: March 2021
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static Eye Gaze Following Task	Eye tracking and accuracy	2 months
Primary	Dynamic Eye Gaze Following Task	Eye tracking and accuracy	2 Months
Primary	Social/Visual Attention Task	Eye tracking	2 Months
Secondary	Social Responsiveness Scale	Parents completing measure of autism-like behavior in adolescents	2 months
Secondary	Social Skills Inventory System - Child version	Adolescents completing measure of social skills and problem behaviors in themselves	2 months
Secondary	Social Skills Inventory System - Adult version	Parents completing measure of social skills and problem behaviors in adolescents	2 months
Secondary	Treatment as Usual	Parents reporting on social and behavioral treatments adolescents receiving in and out of school	2 months

External Links

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