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Behavioral Intervention
Serious Games for Autism (SAGA Trial)
N/A
Waitlist Available
Led By Suzy Scherf
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adolescent scores < 80% correct on online eye gaze screening task
Be younger than 65 years old
Must not have
Having seizures within the previous two years
Being 18 and cannot understand the consent as indicated by failing a quiz prior to signing the consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial will compare the effects of two games on people's behavior, measuring a range of outcomes from controlled tasks to uncontrolled social interactions.
Who is the study for?
This trial is for adolescents with Autism Spectrum Disorder (ASD) aged 10-18 who have normal vision and hearing (with correction), can use a computer, and are native English speakers. They must score below average on an eye gaze task and meet ASD diagnostic criteria. IQ should be between 70-130, reading at least at a 2nd-grade level. Exclusions include recent seizures or legal inability to consent.
What is being tested?
The study tests an intervention video game designed to improve social skills in autistic adolescents against a placebo control game. Participants will be randomly assigned to either group and assessed before, after playing the games, and again six months later across various social behaviors.
What are the potential side effects?
Since this trial involves video games as interventions, there may not be direct medical side effects; however, participants could experience eye strain or mental fatigue from prolonged screen time.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I scored below 80% on an eye tracking test online.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had seizures in the last two years.
Select...
I am over 18 and passed a quiz showing I understand the consent.
Select...
I am 18 and have a legal guardian due to my inability to consent for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Autism Behaviors - Social Responsiveness Scale 2nd Edition (SRS-2)
Primary Target Eye Gaze Mechanisms - Performance Accuracy
Primary Target Eye Gaze Mechanisms - Visual Fixation
+1 moreSecondary study objectives
Face-to-Face Social Interactions - Visual Fixations
Intermediate Face Processing Mechanisms - Face Expression Identification - (CAM)
Intermediate Face Processing Mechanisms - Face Expression Identification - (RMET)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention Video GameExperimental Treatment1 Intervention
Participants will play the Intervention Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session
Group II: Control Video GamePlacebo Group1 Intervention
Participants will play the Control Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session
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Who is running the clinical trial?
Penn State UniversityLead Sponsor
365 Previous Clinical Trials
127,640 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
460 Patients Enrolled for Autism Spectrum Disorder
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,476 Total Patients Enrolled
83 Trials studying Autism Spectrum Disorder
40,537 Patients Enrolled for Autism Spectrum Disorder
Suzy ScherfPrincipal InvestigatorPenn State University
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