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Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Game System for Potential Treatment of Developmental Delays
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring digital, mobile, autism

Eligibility Criteria

2 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Parent or primary caregiver over 18 of a child with autism between ages of 2 and 8.
  2. Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools.

Exclusion Criteria:

1. Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Autism Case Group

Neurotypical Sibling Control Group

Arm Description

Autistic participants will receive mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion.

Neurotypical control participants will receive the same mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion.

Outcomes

Primary Outcome Measures

Preliminary change in parent/caregiver reported socialization on the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12
Study investigators will preliminarily measure change in the Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver Comprehensive form. This will allow study team to understand if use of the mobile app as treatment is feasible. Scores from the socialization domain of the VABS-2 reflects one's functioning in social situations. The socialization subscale is up to 113 items, where raw scores are converted to Intelligence Quotient (IQ) type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.
Mobile Application Usage
Time (in seconds) of app use across the 12 weeks.

Secondary Outcome Measures

Change in parent/caregiver reported social responsiveness from week 0 to week 12
The Social Responsiveness Scale-2 is a 65-item measure where parents/caregivers rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severitySocial Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).
Change in mobile autism risk assessment score from week 0 to week 12
a level 2 screening tool that has been validated in several studies and that uses a brief parent/caregiver questionnaire with a 2 minute home video to generate a classification score that indicates severity of the autism phenotype (ranging from no autistic symptoms to severe autism) as well as confidence in the classification.
Video Based Feature Analysis
Shared videos will be evaluated for proper game play and enjoyment with the game across the 12 week period of the intervention.
Change in Parent/Caregiver Confidence and Resources from baseline to week 12
Two 5 item questions regarding parent/caregiver confidence in their ability to manage their child's behaviors and adequacy of resources to manage their child's behaviors.
Change in Parent Stress Index - Short Form (PSI-SF) from baseline to week 12
The PSI-SF is a 36-item parent report scale that evaluates the extent and source of parent stress in the form of three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores range from 36-180 with lower scores representing less parent stress.
Engagement in gameplay across the 12 week period
The Fun ToolKit and Child Engagement Scale will be adapted and combined to assess children's engagement and enjoyment while playing the app.
Change in Emotion Recognition from baseline to week 12
Study team will use an image based emotion recognition task where participants will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants will select 1 of 8 available Ekman emotion labels for 21 emotional face image stimuli presented in random order. Correct responses will be measured against a predetermined majority rules consensus of the emotional content of the GIFs.
Changes in parent/caregiver reported eye contact and joint attention from week 0 to week 12
Parents/caregivers will rate their child's socially motivated eye contact and joint attention skills pre and post. This will be a 10 item measure.
Change in NIH-Emotion Toolbox from baseline to Week 12
The NIH toolbox for emotion was developed to create a standardized, comprehensive, and concise battery of tests that can recognize the full spectrum of emotional experiences and their impacts on health and wellbeing. The NIH Toolbox for emotion includes 3 subdomains: negative affect, psychological well-being, and social relationships for children 3-7 years old. For the age range of 8-12 proxy measures are available for the same subdomains.

Full Information

First Posted
May 13, 2021
Last Updated
April 13, 2023
Sponsor
Stanford University
Collaborators
National Library of Medicine (NLM)
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1. Study Identification

Unique Protocol Identification Number
NCT04909710
Brief Title
Feasibility of Mobile Game System for Potential Treatment of Developmental Delays
Official Title
Feasibility of Mobile Game System for Potential Treatment of Developmental Delays
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Library of Medicine (NLM)

4. Oversight

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

5. Study Description

Brief Summary
The investigators will test the feasibility and preliminary efficacy of a Mobile game system meant to generate valuable data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism. Investigators will enroll children with autism aged 2-8 years old and their neurotypical sibling or an unrelated neurotypical control (aged 2-8 years old).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
digital, mobile, autism

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The investigators will use parallel assignment to compare the device feasibility across children with autism and neurotypical children, who will serve as controls.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autism Case Group
Arm Type
Experimental
Arm Description
Autistic participants will receive mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion.
Arm Title
Neurotypical Sibling Control Group
Arm Type
Other
Arm Description
Neurotypical control participants will receive the same mobile game system for 12 weeks and be asked to play a minimum of ten 90-second game sessions per week per child over 12 weeks. Research team will further require that at least three of these 10 weekly sessions with each child be with game decks displaying emotion.
Intervention Type
Other
Intervention Name(s)
Mobile Game System for Potential Treatment of Developmental Delays
Intervention Description
This mobile game system is designed to generate valuable data from video, image, and usage data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism.
Primary Outcome Measure Information:
Title
Preliminary change in parent/caregiver reported socialization on the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12
Description
Study investigators will preliminarily measure change in the Vineland Adaptive Behavior Scales, 2d edition (VABS-2) Socialization subscale of the Parent/Caregiver Comprehensive form. This will allow study team to understand if use of the mobile app as treatment is feasible. Scores from the socialization domain of the VABS-2 reflects one's functioning in social situations. The socialization subscale is up to 113 items, where raw scores are converted to Intelligence Quotient (IQ) type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.
Time Frame
Baseline (Week 0), Week 12
Title
Mobile Application Usage
Description
Time (in seconds) of app use across the 12 weeks.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in parent/caregiver reported social responsiveness from week 0 to week 12
Description
The Social Responsiveness Scale-2 is a 65-item measure where parents/caregivers rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severitySocial Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).
Time Frame
Baseline (Week 0), Week 12
Title
Change in mobile autism risk assessment score from week 0 to week 12
Description
a level 2 screening tool that has been validated in several studies and that uses a brief parent/caregiver questionnaire with a 2 minute home video to generate a classification score that indicates severity of the autism phenotype (ranging from no autistic symptoms to severe autism) as well as confidence in the classification.
Time Frame
Baseline (Week 0), Week 12
Title
Video Based Feature Analysis
Description
Shared videos will be evaluated for proper game play and enjoyment with the game across the 12 week period of the intervention.
Time Frame
Week 12
Title
Change in Parent/Caregiver Confidence and Resources from baseline to week 12
Description
Two 5 item questions regarding parent/caregiver confidence in their ability to manage their child's behaviors and adequacy of resources to manage their child's behaviors.
Time Frame
Baseline (Week 0), Week 12
Title
Change in Parent Stress Index - Short Form (PSI-SF) from baseline to week 12
Description
The PSI-SF is a 36-item parent report scale that evaluates the extent and source of parent stress in the form of three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Total scores range from 36-180 with lower scores representing less parent stress.
Time Frame
Baseline (Week 0), Week 12
Title
Engagement in gameplay across the 12 week period
Description
The Fun ToolKit and Child Engagement Scale will be adapted and combined to assess children's engagement and enjoyment while playing the app.
Time Frame
Week 12
Title
Change in Emotion Recognition from baseline to week 12
Description
Study team will use an image based emotion recognition task where participants will select the emotion that corresponds to an emotional facial image in the form of a GIF (Graphics Interchange Format) image. Participants will select 1 of 8 available Ekman emotion labels for 21 emotional face image stimuli presented in random order. Correct responses will be measured against a predetermined majority rules consensus of the emotional content of the GIFs.
Time Frame
Baseline (Week 0), Week 12
Title
Changes in parent/caregiver reported eye contact and joint attention from week 0 to week 12
Description
Parents/caregivers will rate their child's socially motivated eye contact and joint attention skills pre and post. This will be a 10 item measure.
Time Frame
Baseline (Week 0), Week 12
Title
Change in NIH-Emotion Toolbox from baseline to Week 12
Description
The NIH toolbox for emotion was developed to create a standardized, comprehensive, and concise battery of tests that can recognize the full spectrum of emotional experiences and their impacts on health and wellbeing. The NIH Toolbox for emotion includes 3 subdomains: negative affect, psychological well-being, and social relationships for children 3-7 years old. For the age range of 8-12 proxy measures are available for the same subdomains.
Time Frame
Baseline (Week 0), Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parent or primary caregiver over 18 of a child with autism between ages of 2 and 8. Autism diagnosis confirmed by a screener such as the Mobile Autism Risk Assessment (MARA) and or similar published tools. Exclusion Criteria: 1. Physical, intellectual, language related, or environmental limitations that prevent the ability for the family to play the game as intended.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis P Wall, PhD
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Within 1 year after study completion

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Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

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