Using Serious Games to Improve Social Skills in Autism (SAGA)

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Autism Spectrum Disorder; Autism

Treatments: Behavioral: Intervention Video Game; Behavioral: Placebo Control Game

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03690661

R33MH110624 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

Intervention Video Game

Experimental group

Description:

Participants will play the Intervention Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session

Treatment:

Behavioral: Intervention Video Game

Control Video Game

Placebo Comparator group

Description:

Participants will play the Control Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session

Treatment:

Behavioral: Placebo Control Game