Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices

Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices, Phase 2 Trials

A new company called CogCubed has created a new game based on the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are unique, motion-sensitive wireless blocks that contain multiple sensors that can interact with one another. CogCubed is providing the data for this study. The game will be played in a 30 minute sessions by subjects ages 6-17. Subjects recruited to play the game will be those with ADHD and those without, matched by gender and age. Those with comorbidities of developmental delay, mental retardation, psychosis, schizophrenia, bipolar disorder and substance use disorders will be excluded, as well as any physiological disability that affects upper limb movement and/or coordination. Informed consent will be obtained from parents and patient prior to administering the game. Parents will fill out a Conner's Brief Rating Scale and a Conner's Brief Rating Scale, Teacher's version will also be supplied to be filled out at school. The hypothesis is that by analyzing data generated from this new gaming platform named Sifteo for which a game was created, which uses auditory and visual stimuli and distracters, the investigators expect that they will be able to provide a more accurate profile of impulsivity and inattention.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Device: Groundskeeper game for controls; Device: Groundskeeper game for ADHD

Detailed Description

Current diagnostic aids used in treating ADHD are currently expensive, time intensive, and provide little information about accessory movements in response to a stimulus. One in ten children, ages 5 to 17, has been diagnosed with ADHD.

Tests such as the Conners' Rating Scale require subjective responses from parents and teachers, making coordination difficult. The computerized Conners' Continuous Performance Test (CPT) provides objective data in regards to inattention and impulsive patterns of response. However, it does not provide data regarding accessory movements such as restlessness, hyperactivity, and other inappropriate movements. If the subject taking the exam has a reading disorder, it will impair his or her ability to respond accurately and it will increase response time. The T.O.V.A. is another computer based test used as a diagnostic aid for ADHD, which uses a microswitch to record responses. It does utilize auditory and visual stimuli, which removes the reading level limitation. However, it is unable to measure to measure accessory movements that may be contributing to reaction time and errors of omission and commission.

Because of these limitations, a new company called CogCubed has created a new game based on the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are unique, motion-sensitive wireless blocks that contain multiple sensors that can interact with one another. CogCubed is providing the data for this study. The game will be played in a 30 minute sessions by subjects ages 6-17. Subjects recruited to play the game will be those with ADHD and those without, matched by gender and age. Those with comorbidities of developmental delay, mental retardation, psychosis, schizophrenia, bipolar disorder and substance use disorders will be excluded, as well as any physiological disability that affects upper limb movement and/or coordination. Informed consent will be obtained from parents and patient prior to administering the game. Parents will fill out a Conner's Brief Rating Scale and a Conner's Brief Rating Scale, Teacher's version will also be supplied to be filled out at school.

The hypothesis is that by analyzing data generated from this new gaming platform named Sifteo for which a game was created, which uses auditory and visual stimuli and distracters, the investigators expect that they will be able to provide a more accurate profile of impulsivity and inattention. The investigators expect that inattention will have more errors of omission and less tilt movements than control and impulsivity will be represented as more commission and greater tilting movements than control. This trial builds on the previous results of our phase 1 trials used to create the predictive algorithms to analyze the data and predict the likelihood of ADHD diagnosis based on patterns of game play behavior.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Groves Academy
    • Waconia, Minnesota, United States, 55387
      • Egli Assessment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 6-17, males and females
• Individuals with ADHD
• Individuals without ADHD
• Depressive Disorders
• Anxiety Disorders
• Oppositional Defiant Disorder
• Panic Disorder
• Eating Disorder

Exclusion Criteria:

• Developmental Delay
• IQ below 70
• Low functioning Autism Spectrum Disorders
• Psychosis
• Substance Use Disorders
• Medical comorbidities that involve any motoric disability that affects upper-limb movement and/or strength

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Controls who played Groundskeeper game; Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities.	Device: Groundskeeper game for controls; The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes.
Active Comparator: Probands played groundskeeper game; Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities	Device: Groundskeeper game for ADHD; The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game	ROC charts the false-positive (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of the Groundskeeper game at discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Groundskeeper game for ADHD. For each participant, predicted values were computed from the logistic regression models (correcting for age, sex and medication status). For each successive point on the logit scale sensitivity and specificity of the logit was computed as a predictor of ADHD diagnosis, by predicting those higher than the cut-point to have ADHD and the others not to have ADHD. These data were used to draw the ROC curve. ROC analysis summarized diagnostic efficiency with the area under the curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor).	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)	Parent completed the Connors Brief rating Scale Parent Version, with the Inattention subscale extracted for analysis. Scores for this assessment are converted to percentile scores for each age group with higher scores indicating more likelihood of ADHD. ROC charts the false-positive rate (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Conners Scale for ADHD. ROC analysis summarizes diagnostic efficiency with the area under the curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor).	30 minutes
Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)	CPT measures sustained attention. Participants were asked to press the space bar whenever any letter except the letter "X: appeared on the computer screen. Used the percent certainty that the CPT II results were in the clinical range in this analysis. ROC charts the false-positive rate (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Conners scales for ADHD. ROC analysis summarizes diagnostic efficiency with the Area Under the Curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor).	30 minutes

Collaborators and Investigators

• Sponsor: CogCubed, Corp
• Investigators: Principal Investigator: Monika D Roots, MD, CogCubed, Corp; Principal Investigator: Jaideep Srivastava, PhD, CogCubed, Corp

Publications and helpful links

General Publications

• Faraone SV, Newcorn JH, Antshel KM, Adler L, Roots K, Heller M. The Groundskeeper Gaming Platform as a Diagnostic Tool for Attention-Deficit/Hyperactivity Disorder: Sensitivity, Specificity, and Relation to Other Measures. J Child Adolesc Psychopharmacol. 2016 Oct;26(8):672-685. doi: 10.1089/cap.2015.0174. Epub 2016 Apr 22.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): December 5, 2016
• Study Completion (Actual): December 5, 2016

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (Estimate): October 22, 2012

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: ADHD
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 131209-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No