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

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Video Game
Placebo Control Game
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autism Spectrum Disorder focused on measuring adolescent, face, social skills, video game

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • Pennsylvania State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Video Game

Control Video Game

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

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).
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).
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).
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).
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).

Full Information

First Posted
September 20, 2018
Last Updated
July 5, 2022
Sponsor
Penn State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03690661
Brief Title
Using Serious Games to Improve Social Skills in Autism
Acronym
SAGA
Official Title
Using Serious Games to Improve Social Skills in Autism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
adolescent, face, social skills, video game

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Video Game
Arm Type
Experimental
Arm Description
Participants will play the Intervention Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session
Arm Title
Control Video Game
Arm Type
Placebo Comparator
Arm Description
Participants will play the Control Video Game for 3 months, 3 times a week for a minimum of 30 minutes each session
Intervention Type
Behavioral
Intervention Name(s)
Intervention Video Game
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Control Game
Intervention Description
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 Measure Information:
Title
Primary Target Eye Gaze Mechanisms - Performance Accuracy
Description
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).
Time Frame
6 months
Title
Primary Target Eye Gaze Mechanisms - Visual Fixation
Description
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).
Time Frame
6 months
Title
Social Symptoms - Social Skills Inventory System (SSIS)
Description
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).
Time Frame
6 months
Title
Autism Behaviors - Social Responsiveness Scale 2nd Edition (SRS-2)
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Intermediate Face Processing Mechanisms - Face Identity (CFMT)
Description
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).
Time Frame
6 months
Title
Intermediate Face Processing Mechanisms - Object Identity (CBMT)
Description
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).
Time Frame
6 months
Title
Intermediate Face Processing Mechanisms - Face Expression Identification - (CAM)
Description
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).
Time Frame
6 months
Title
Intermediate Face Processing Mechanisms - Face Expression Identification - (RMET)
Description
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).
Time Frame
6 months
Title
Face-to-Face Social Interactions - Visual Fixations
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: parent/caregiver of an adolescent with a diagnosis of autism spectrum disorder (ASD), parent/caregiver and adolescent with ASD both native English speakers, adolescent with ASD aged between 10-18 years at pre-test, adolescent has normal vision and hearing with correction as reported by caregiver, adolescent is able to use a computer for the purposes of game play, adolescent scores < 80% correct (i.e., 0.5 SD less than Mean of typically developing adolescents) on online eye gaze screening task, 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); Full Scale IQ of adolescent determined to be between 70-130; reading ability of adolescent determined to be at least a 2nd grade level; adolescent is capable of cooperating with testing; parent/caregiver and adolescent both consent/assent to participate in the research. Exclusion Criteria: having seizures within the previous two years no stable internet connection in the home refusing to consent/assent to take part in the research 18 and have a legal guardian, which prohibits them from legally consenting for themselves 18 and cannot understand the consent as indicated by failing a quiz prior to signing the consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzy Scherf
Phone
814-867-2921
Email
suzyscherf@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzy Scherf
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzy S Scherf
Phone
814-867-2921
Email
suzyscherf@psu.edu
First Name & Middle Initial & Last Name & Degree
Suzy Scherf, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants will be invited to share de-identified data acquired from this study with the National Institutes of Health Data Archive

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Using Serious Games to Improve Social Skills in Autism

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