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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02968225
Acronym
SAGA
Enrollment
40
Registered
2016-11-18
Start date
2016-08-31
Completion date
2018-10-31
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

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.

Interventions

BEHAVIORALComputer 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.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

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.

Intervention model description

Participants randomized into intervention or standard care control conditions

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Static Eye Gaze Following Task2 monthsEye tracking and accuracy
Dynamic Eye Gaze Following Task2 MonthsEye tracking and accuracy
Social/Visual Attention Task2 MonthsEye tracking

Secondary

MeasureTime frameDescription
Social Responsiveness Scale2 monthsParents completing measure of autism-like behavior in adolescents
Treatment as Usual2 monthsParents reporting on social and behavioral treatments adolescents receiving in and out of school
Social Skills Inventory System - Child version2 monthsAdolescents completing measure of social skills and problem behaviors in themselves
Social Skills Inventory System - Adult version2 monthsParents completing measure of social skills and problem behaviors in adolescents

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026