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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder; Autism
• Intervention / Treatment: Behavioral: Intervention Video Game; Behavioral: Placebo Control Game

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzy Scherf; Phone Number: 814-867-2921; Email: suzyscherf@psu.edu

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Video Game; Participants will play the Intervention Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session	Behavioral: Intervention Video Game; The intervention game employs evidence-based "serious game" mechanics (e.g., storylines, long-term goals, scaling difficulty) to design a learning environment that maximizes opportunities for adolescents with ASD to discover the functional utility of eye gaze cues.
Placebo Comparator: Control Video Game; Participants will play the Control Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session	Behavioral: Placebo Control Game; The placebo game will have all the elements of the serious game mechanics of the intervention game (narrative storylines, long-term goals, scaling difficulty), but will not provide the learning opportunities regarding eye gaze cues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Target Eye Gaze Mechanisms - Performance Accuracy	Performance accuracy will be acquired from both a static and a dynamic task of eye gaze cue following, which will be analyzed separately (ie 6 months from pre-intervention).	6 months
Primary Target Eye Gaze Mechanisms - Visual Fixation	Eye tracking measures of visual fixation will be acquired in both a static and a dynamic task of eye gaze cue following, which will be analyzed separately (ie 6 months from pre-intervention).	6 months
Social Symptoms - Social Skills Inventory System (SSIS)	Social skills and problematic behaviors will be assessed via parent- and self-reported responses on the SSIS. These measures will be administered at multiple time points including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months
Autism Behaviors - Social Responsiveness Scale 2nd Edition (SRS-2)	To assess potential changes in autism-like behaviors and symptoms, parents will complete the SRS-2 at each of 3 time points (pre-intervention, post-intervention, 3-month follow-up after intervention completion).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intermediate Face Processing Mechanisms - Face Identity (CFMT)	Accuracy in face recognition will be assessed via standardized measures including Cambridge face memory task (CFMT) at each time point including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months
Intermediate Face Processing Mechanisms - Object Identity (CBMT)	Accuracy in object recognition will be assessed via standardized measures including Cambridge bike memory task (CBMT) at each time point including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months
Intermediate Face Processing Mechanisms - Face Expression Identification - (CAM)	Accuracy in face expression identification will be assessed via standardized measures including the face portion of the Cambridge Affective Memory task (CAM) at each time point including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months
Intermediate Face Processing Mechanisms - Face Expression Identification - (RMET)	Accuracy in face expression identification will be assessed via standardized measures including the face portion of the Reading the Mind in the Eyes Test (RMET) at each time point including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months
Face-to-Face Social Interactions - Visual Fixations	Eye tracking measures (ie visual fixations) will be collected during a naturalistic social conversation. Additionally, eye tracking measures will be collected during an interactive cued eye gaze task, which requires participants to select the object that a real person is looking at. These measures will be assessed at multiple time points including pre-intervention, post-intervention, and 3 months after the intervention (ie 6 months from pre-intervention).	6 months

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Suzy Scherf, Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): January 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: adolescent; social skills; video game; face
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: R33MH110624 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participants will be invited to share de-identified data acquired from this study with the National Institutes of Health Data Archive
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No