Trial Outcomes & Findings for Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices (NCT NCT01711372)
NCT ID: NCT01711372
Last Updated: 2019-12-03
Results Overview
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).
COMPLETED
NA
113 participants
30 minutes
2019-12-03
Participant Flow
Invited for participation consecutive patients referred to a child psychiatrist. From this cohort of patients, two groups formed. Patients who had received ADHD diagnosed and those who had not.
113 patients were screened for ADHD vs no ADHD. Those with ADHD were asked to not take stimulant medications for at least 3 days prior to participating. Company no longer exists and no longer has access to data collected. Only information in published study results available.
Participant milestones
| Measure |
ADHD Group
Patients with ADHD played a go/no go task on Sifteo cubes to assess for attentional capabilities. Groundskeeper Game: The Groundskeeper game is a go/no-go task that captures reaction time and movement using the accelerometers and touch capabilities on the Sanvello cubes.
|
Control Group
Controls played a go/no go task on Sifteo cubes to assess for attentional capabilities. Groundskeeper Game: The Groundskeeper game is a go/no-go task that captures reaction time and movement using the accelerometers and touch capabilities on the Sanvello cubes.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
47
|
|
Overall Study
COMPLETED
|
66
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices
Baseline characteristics by cohort
| Measure |
ADHD Group
n=66 Participants
Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities.
Groundskeeper Game: 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.
|
Control Group
n=47 Participants
Controls played a go/no go task on Sifteo Cubes to asses for attentional capabilities.
Groundskeeper Game: 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.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
66 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
58 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
47 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Psychiatric Disorders
Anxiety Disorders
|
33 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Psychiatric Disorders
Mood Disorders
|
27 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Psychiatric Disorders
Disruptive Behavior Disorders
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Psychiatric Disorders
Autism Spectrum Disorders
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Psychiatric Disorders
Reading Disability
|
23 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.
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).
Outcome measures
| Measure |
All Participants in the Study With and Without ADHD
n=113 Participants
Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.
|
|---|---|
|
Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game
|
0.78 Proportion of accurate ADHD Diagnoses
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.
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).
Outcome measures
| Measure |
All Participants in the Study With and Without ADHD
n=113 Participants
Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.
|
|---|---|
|
Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)
|
0.76 Proportion of accurate ADHD Diagnoses
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.
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).
Outcome measures
| Measure |
All Participants in the Study With and Without ADHD
n=113 Participants
Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.
|
|---|---|
|
Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)
|
0.62 Proportion of accurate ADHD Diagnoses
|
Adverse Events
ADHD Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place