N/A
N=113
Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01711372 ↗Enrolled (actual)
113
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game — 0.78 Proportion of accurate ADHD Diagnoses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Groundskeeper game for controls (Device); Groundskeeper game for ADHD (Device)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- CogCubed, Corp
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game |
0.78 | — |
| SECONDARY Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale) |
0.76 | — |
| SECONDARY Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT) |
0.62 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01711372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.