Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Groundskeeper game for controls
Groundskeeper game for ADHD
Sponsored by
About this trial
This is an interventional screening trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD
Eligibility Criteria
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
Sites / Locations
- Groves Academy
- Egli Assessment
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Controls who played Groundskeeper game
Probands played groundskeeper game
Arm Description
Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities.
Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01711372
Brief Title
Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices
Official Title
Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices, Phase 2 Trials
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2012 (Actual)
Primary Completion Date
December 5, 2016 (Actual)
Study Completion Date
December 5, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CogCubed, Corp
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were those with ADHD and age and gender matched controls who completed a game placed on Sifteo cubes to assess for ADHD. The intervention was a game to screen for ADHD.
Masking
InvestigatorOutcomes Assessor
Masking Description
The person having the patient play the came did not know if the patient had ADHD or not.
Allocation
Non-Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controls who played Groundskeeper game
Arm Type
Placebo Comparator
Arm Description
Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities.
Arm Title
Probands played groundskeeper game
Arm Type
Active Comparator
Arm Description
Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities
Intervention Type
Device
Intervention Name(s)
Groundskeeper game for controls
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Groundskeeper game for ADHD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game
Description
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).
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)
Description
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).
Time Frame
30 minutes
Title
Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)
Description
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).
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika D Roots, MD
Organizational Affiliation
CogCubed, Corp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaideep Srivastava, PhD
Organizational Affiliation
CogCubed, Corp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groves Academy
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Egli Assessment
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27105181
Citation
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.
Results Reference
result
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Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices
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