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

NCT ID: NCT02968225

Last Updated: 2021-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomized into intervention or standard care control conditions
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Computer Game

All Computer Game participants will complete:

* online screening
* Diagnostic and eye-tracking pre-testing
* 2 month intervention
* Eye-tracking post-testing

Group Type EXPERIMENTAL

Computer Game

Intervention Type 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.

Waitlist control

All Treatment as usual control participants will complete:

* online screening
* Diagnostic and eye-tracking pre-testing
* Eye-tracking post-testing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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K. Suzanne Scherf

Associate Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzy Scherf, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

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Pennsylvania State University

University Park, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38182792 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30287612 (View on PubMed)

Related Links

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https://bmjopen.bmj.com/content/bmjopen/8/9/e023682.full.pdf

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

Other Identifiers

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R61MH110624

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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