Clinical trial NCT02968225: Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism
Official title: Using Serious Game Technology to Improve Sensitivity to Eye Gaze in Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2016-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized into intervention or standard care control conditions
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Static Eye Gaze Following Task
timeFrame: 2 months
measure: Dynamic Eye Gaze Following Task
timeFrame: 2 Months
measure: Social/Visual Attention Task
timeFrame: 2 Months
Secondary outcomes:
measure: Social Responsiveness Scale
timeFrame: 2 months
measure: Social Skills Inventory System - Child version
timeFrame: 2 months
measure: Social Skills Inventory System - Adult version
timeFrame: 2 months
measure: Treatment as Usual
timeFrame: 2 months
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Suzy Scherf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.