Attention Deficit Hyperactivity DisorderNCT01711372
Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices
A study testing Groundskeeper game for ADHD in people with Attention Deficit Hyperactivity Disorder, run by CogCubed, Corp at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Groundskeeper game for ADHD
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2012to 5 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-17, males and females
- Individuals with ADHD
- Individuals without ADHD
- Depressive Disorders
- Anxiety Disorders
- Oppositional Defiant Disorder
- Panic Disorder
- Eating Disorder
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Groves Academy
Saint Louis Park, Minnesota, 55416
Egli Assessment
Waconia, Minnesota, 55387
About this study
Official title: 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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Groundskeeper game for controls, Groundskeeper game for ADHD
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Groundskeeper game for controlsDevice
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.
Groundskeeper game for ADHDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Controls who played Groundskeeper game | Placebo comparator | Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities. Receives: Device: Groundskeeper game for controls |
| Probands played groundskeeper game | Active comparator | Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities Receives: Device: Groundskeeper game for ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 minutes
Secondary outcomes (2)
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).
Measured: 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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study start1 Jun 2012
- Primary completion5 Dec 2016
- Study completion5 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- CogCubed, Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika D Roots, MD, Principal investigator, CogCubed, CorpJaideep Srivastava, PhD, Principal investigator, CogCubed, Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711372
- Sponsor's protocol ID
- 131209-12
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2012
- Last updated
- 3 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 27105181
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices, Phase 2 Trials
- ClinicalTrials.gov ID
- NCT01711372
- Acronym / sponsor ID
- 131209-12
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- CogCubed, CorpIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 5 Dec 2016 (actual)
- Study completion
- 5 Dec 2016 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Posted 3 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Controls who played Groundskeeper game | Placebo comparator | Device: Groundskeeper game for controlsControls played a go/no go task on Sifteo cubes to asses for attentional capabilities. |
| Probands played groundskeeper game | Active comparator | Device: Groundskeeper game for ADHDPatients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 6-17, males and females
- Individuals with ADHD
- Individuals without ADHD
- Depressive Disorders
- Anxiety Disorders
Key exclusion criteria (6 listed)
- Developmental Delay
- IQ below 70
- Low functioning Autism Spectrum Disorders
- Psychosis
- Substance Use Disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Groundskeeper game for controlsThe Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes. | Device | Controls who played Groundskeeper game |
| Groundskeeper game for ADHDThe Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes. | Device | Probands played groundskeeper game |
Primary outcome
Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game
Time frame: 30 minutes
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).
2 secondary outcomes
Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)
Time frame: 30 minutes
Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27105181Faraone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika D Roots, MD principal investigator
CogCubed, Corp
Jaideep Srivastava, PhD principal investigator
CogCubed, Corp
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Groundskeeper game for ADHD in people with Attention Deficit Hyperactivity Disorder, run by CogCubed, Corp at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01711372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.