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

NCT02968225 | Completed Phase 2 DMC

• 1 other identifier: R61MH110624
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Social Responsiveness Scale

  2 months

• Social Skills Inventory System - Child version

  2 months

• Social Skills Inventory System - Adult version

  2 months

• Treatment as Usual

  2 months

Study Arms (2)

Computer Game

EXPERIMENTAL

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

Behavioral: Computer Game

Waitlist control

NO INTERVENTION

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

Interventions

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.

Computer Game

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Penn State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (2)

• Scherf KS, Griffin JW, Geier CF, Smyth JM. Social visual attention as a treatment outcome: evaluating the social games for autistic adolescents (SAGA) intervention. Sci Rep. 2024 Jan 5;14(1):619. doi: 10.1038/s41598-024-51332-z.

  PMID: 38182792 DERIVED

• 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.

  PMID: 30287612 DERIVED

Related Links

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

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Suzy Scherf, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Model Details: Participants randomized into intervention or standard care control conditions

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)