Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices

NCT01711372 | Completed Results

• 1 other identifier: 131209-12
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)

  30 minutes

• Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)

  30 minutes

Study Arms (2)

Controls who played Groundskeeper game

PLACEBO COMPARATOR

Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities.

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

Device: Groundskeeper game for ADHD

Interventions

Groundskeeper game for controls DEVICE

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.

Controls who played Groundskeeper game

Groundskeeper game for ADHD DEVICE

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.

Probands played groundskeeper game

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• CogCubed, Corp: lead

Study Sites (2)

Groves Academy

Saint Louis Park, Minnesota, 55416, United States

Location

Egli Assessment

Waconia, Minnesota, 55387, United States

Location

Related Publications (1)

• 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.

  PMID: 27105181 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr Monika Roots, Chief Medical Officer
• Organization: CogCubed

monika@cogcubed.com

6173082009

Study Officials

• Monika D Roots, MD

  CogCubed, Corp

  PRINCIPAL INVESTIGATOR

• Jaideep Srivastava, PhD

  CogCubed, Corp

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The person having the patient play the came did not know if the patient had ADHD or not.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 22, 2012
• Study Start: June 1, 2012
• Primary Completion: December 5, 2016
• Study Completion: December 5, 2016
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)