Feasibility of Mobile Game System for Potential Treatment of Developmental Delays

April 13, 2023 updated by: Dennis Paul Wall, Stanford University
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Autism Case Group
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.
Other: Mobile Game System for Potential Treatment of Developmental Delays
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.
Other: Neurotypical Sibling Control Group
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.
Other: Mobile Game System for Potential Treatment of Developmental Delays
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preliminary change in parent/caregiver reported socialization on the Vineland Adaptive Behavior Scales,2nd Edition (VABS-2) from baseline to week 12
Time Frame: Baseline (Week 0), 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.
Baseline (Week 0), Week 12
Mobile Application Usage
Time Frame: Week 12
Time (in seconds) of app use across the 12 weeks.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in parent/caregiver reported social responsiveness from week 0 to week 12
Time Frame: Baseline (Week 0), 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).
Baseline (Week 0), Week 12
Change in mobile autism risk assessment score from week 0 to week 12
Time Frame: Baseline (Week 0), 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.
Baseline (Week 0), Week 12
Video Based Feature Analysis
Time Frame: Week 12
Shared videos will be evaluated for proper game play and enjoyment with the game across the 12 week period of the intervention.
Week 12
Change in Parent/Caregiver Confidence and Resources from baseline to week 12
Time Frame: Baseline (Week 0), 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.
Baseline (Week 0), Week 12
Change in Parent Stress Index - Short Form (PSI-SF) from baseline to week 12
Time Frame: Baseline (Week 0), 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.
Baseline (Week 0), Week 12
Engagement in gameplay across the 12 week period
Time Frame: Week 12
The Fun ToolKit and Child Engagement Scale will be adapted and combined to assess children's engagement and enjoyment while playing the app.
Week 12
Change in Emotion Recognition from baseline to week 12
Time Frame: Baseline (Week 0), 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.
Baseline (Week 0), Week 12
Changes in parent/caregiver reported eye contact and joint attention from week 0 to week 12
Time Frame: Baseline (Week 0), 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.
Baseline (Week 0), Week 12
Change in NIH-Emotion Toolbox from baseline to Week 12
Time Frame: Baseline (Week 0), 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.
Baseline (Week 0), Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Library of Medicine (NLM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 39562
  • 5R01LM013364 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Within 1 year after study completion

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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