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

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ClinicalTrials.gov Identifier: NCT03690661
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
K. Suzanne Scherf, Penn State University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Behavioral: Intervention Video Game Behavioral: Placebo Control Game Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Fully blinded
Primary Purpose: Basic Science
Official Title: Using Serious Games to Improve Social Skills in Autism
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Primary Target Eye Gaze Mechanisms - Performance Accuracy [ Time Frame: 6 months ]
    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).

  2. Primary Target Eye Gaze Mechanisms - Visual Fixation [ Time Frame: 6 months ]
    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).

  3. Social Symptoms - Social Skills Inventory System (SSIS) [ Time Frame: 6 months ]
    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).

  4. Autism Behaviors - Social Responsiveness Scale 2nd Edition (SRS-2) [ Time Frame: 6 months ]
    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).


Secondary Outcome Measures :
  1. Intermediate Face Processing Mechanisms - Face Identity (CFMT) [ Time Frame: 6 months ]
    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).

  2. Intermediate Face Processing Mechanisms - Object Identity (CBMT) [ Time Frame: 6 months ]
    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).

  3. Intermediate Face Processing Mechanisms - Face Expression Identification - (CAM) [ Time Frame: 6 months ]
    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).

  4. Intermediate Face Processing Mechanisms - Face Expression Identification - (RMET) [ Time Frame: 6 months ]
    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).

  5. Face-to-Face Social Interactions - Visual Fixations [ Time Frame: 6 months ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 in lab via the Autism Diagnostic Observation Schedule (ADOS-2);
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690661


Contacts
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Contact: Suzy Scherf 814-867-2921 suzyscherf@psu.edu

Locations
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United States, Pennsylvania
Pennsylvania State University Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Suzy S Scherf    814-867-2921    suzyscherf@psu.edu   
Principal Investigator: Suzy Scherf, PhD         
Sponsors and Collaborators
Penn State University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Suzy Scherf Penn State University

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Responsible Party: K. Suzanne Scherf, Associate Professor of Psychology, Penn State University
ClinicalTrials.gov Identifier: NCT03690661     History of Changes
Other Study ID Numbers: R33MH110624 ( U.S. NIH Grant/Contract )
R33MH110624 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants will be invited to share de-identified data acquired from this study with the National Institutes of Health Data Archive
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by K. Suzanne Scherf, Penn State University:
adolescent
face
social skills
video game
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders