Clinical trial NCT03690661: Using Serious Games to Improve Social Skills in Autism
Official title: Using Serious Games to Improve Social Skills in Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: adolescent
face
social skills
video game
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-10-01
Enrollment: 43
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will conduct a small-scale randomized control trial comparing the intervention game to an active control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). These outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to uncontrolled, real-world social interactions between dyads.

Detailed description: The investigators will conduct a small-scale randomized control trial comparing the intervention game to an placebo control game, and will assess outcomes at multiple time points (pre-, post-, 6-month follow-up). These outcomes will include a wide range of behaviors that are measured along a continuum from controlled lab-based tasks to real-world social interactions between dyads. The aims are evaluating 1) changes in the target mechanisms (social attention to faces, sensitivity to eye gaze cues) for the intervention relative to active control group, 2) engagement of intermediate mechanisms, including face-processing behaviors and real-world social communication behaviors, and 3) the relation between engagement of the target and intermediate mechanisms and symptom outcomes. Evidence of changes in autism social symptoms resulting from changing visual attention to faces and/or improved ability to understand eye gaze cues will provide clear evidence to inform a "go" decision about the therapeutic target for further clinical development.

Eligibility criteria: Inclusion Criteria:

1. parent/caregiver of an adolescent with a diagnosis of autism spectrum disorder (ASD),
2. parent/caregiver and adolescent with ASD both native English speakers,
3. adolescent with ASD aged between 10-18 years at pre-test,
4. adolescent has normal vision and hearing with correction as reported by caregiver,
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 Mean of typically developing adolescents) on online eye gaze screening task,
7. ASD diagnosis of adolescent confirmed via Parent-report SCQ and clinical interview with adolescent to assess DSM-V criteria (borderline cases also undergo ADI interview);
8. Full Scale IQ of adolescent determined to be between 70-130;
9. reading ability of adolescent determined to be at least a 2nd grade level;
10. adolescent is capable of cooperating with testing;
11. parent/caregiver and adolescent both consent/assent to participate in the research.

Exclusion Criteria:

1. having seizures within the previous two years
2. no stable internet connection in the home
3. refusing to consent/assent to take part in the research
4. 18 and have a legal guardian, which prohibits them from legally consenting for themselves
5. 18 and cannot understand the consent as indicated by failing a quiz prior to signing the consent.

Primary outcomes:
measure: Primary Target Eye Gaze Mechanisms - Performance Accuracy
timeFrame: 6 months
measure: Primary Target Eye Gaze Mechanisms - Visual Fixation
timeFrame: 6 months
measure: Social Symptoms - Social Skills Inventory System (SSIS)
timeFrame: 6 months
measure: Autism Behaviors - Social Responsiveness Scale 2nd Edition (SRS-2)
timeFrame: 6 months
Secondary outcomes:
measure: Intermediate Face Processing Mechanisms - Face Identity (CFMT)
timeFrame: 6 months
measure: Intermediate Face Processing Mechanisms - Object Identity (CBMT)
timeFrame: 6 months
measure: Intermediate Face Processing Mechanisms - Face Expression Identification - (CAM)
timeFrame: 6 months
measure: Intermediate Face Processing Mechanisms - Face Expression Identification - (RMET)
timeFrame: 6 months
measure: Face-to-Face Social Interactions - Visual Fixations
timeFrame: 6 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
role: PRINCIPAL_INVESTIGATOR
References: