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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

Tracking Information
First Submitted Date  ICMJE September 20, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date October 29, 2019
Estimated Study Start Date  ICMJE November 15, 2019
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03690661 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Serious Games to Improve Social Skills in Autism
Official Title  ICMJE Using Serious Games to Improve Social Skills in Autism
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Fully blinded
Primary Purpose: Basic Science
Condition  ICMJE
  • Autism Spectrum Disorder
  • Autism
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Intervention Video Game
  • 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
    Intervention: Behavioral: Placebo Control Game
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Suzy Scherf 814-867-2921 suzyscherf@psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03690661
Other Study ID Numbers  ICMJE R33MH110624( U.S. NIH Grant/Contract )
R33MH110624 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Informed Consent Form (ICF)
Responsible Party K. Suzanne Scherf, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Suzy Scherf Penn State University
PRS Account Penn State University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP