This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices in Adults (NCT02127931), a non-randomized na study. The primary outcome is Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02127931 |
| Phase | NA |
| Condition | Attention Deficit Hyperactivity Disorder |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | CogCubed, Corp |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns adults, including participants with ADHD and controls without ADHD. The record describes the game as intended for subjects aged 18 and over and lists an enrollment of 18. The registry record does not report further details about the participants who contributed to the primary outcome.
Intervention
Participants in the ADHD group played Groundskeeper, described as a video game diagnostic tool, on Sifteo cubes. The record describes the devices as hands-on, motion-sensitive wireless blocks with sensors that can interact with one another. The game was described as being played in 30 minute sessions.
Comparator
The control group also played Groundskeeper on Sifteo cubes. The arm descriptions refer to age- and gender-matched controls without ADHD, but allocation was non-randomized. The registry record therefore does not support treating the arms as a randomized, like-for-like comparison.
Primary question
The primary outcome counts participants testing high, defined as 6 or more symptoms, for ADHD types determined by the Adult ADHD DSM IV-TR Checklist. The checklist distinguishes inattentive ADHD, hyperactive/impulsive ADHD, and combined ADHD. The broader study description concerns whether an interactive game could capture information relevant to executive functioning and ADHD symptoms. However, the registry record does not report the outcome counts or results needed to assess the relationship between game data and checklist classifications.
3. Trial Design
This completed study is registered as NCT02127931 and sponsored by CogCubed, Corp. The record identifies the design as parallel, non-randomized, and double masked. It lists the phase as NA and enrollment as 18. The recorded start is 2014-03, and primary completion is 2016-12-01. These registration details describe the study structure, but do not establish how participants were recruited, assigned, or retained.
The two groups are described as an ADHD group and a control group, and both played Groundskeeper on Sifteo cubes. The arm descriptions state that the controls were matched by age and gender. Because allocation was non-randomized, any contrast between groups could reflect differences other than ADHD status or game performance. The registry record does not report how matching was implemented or whether the analysis accounted for it.
Although double masking is recorded, the registry record does not identify who was masked or how masking was maintained. It also does not report the specific allocation process, the study protocol, or the statistical analysis plan. Those omissions limit the ability to evaluate protection against bias or to determine whether the reported design was followed as intended.
The brief description says participants aged 18 and over would play in 30 minute sessions. The primary outcome lists a timeframe of 10 minutes. The registry record does not explain how these two time descriptions relate. It also states that the company no longer exists and no longer has access to the collected data, and that only information from a draft publication is available. Numerical primary outcome results are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Company no longer exists, and no longer has access to data collected. Only information from draft publication available.
Overall Study
| Stage | All Participants |
|---|---|
| STARTED | 18 |
| COMPLETED | 17 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | All Participants |
|---|---|
| Glitch in Game | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Company no longer exists, and no longer has access to data collected. Only information from draft publication available.
| Characteristic | Unit | All Participants |
|---|---|---|
| Participants analysed | 18 | |
| Age, Customized: 18-25 years | Participants | 18 |
| Sex/Gender, Customized: NA | Participants | 0 |
| Race/Ethnicity, Customized: N/A | Participants | 0 |
| Region of Enrollment: United States | Participants | 18 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist, measured over 10 minutes.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants who tested high, defined as 6 or more symptoms, for ADHD by type according to the Adult ADHD DSM IV-TR Checklist. The listed types are inattentive ADHD (ADHD-I), hyperactive/impulsive ADHD (ADHD-H/I), and combined ADHD (ADHD-C). The outcome is a count of participants meeting the stated symptom threshold, rather than a continuous score or a direct measure of game performance. Its listed timeframe is 10 minutes.
A symptom checklist can provide a structured way to classify reported symptoms. In this study, the endpoint could describe how many participants met the checklist threshold in each ADHD type. Such counts alone would not show whether the game accurately identifies a diagnosis, predicts symptom status, or adds information beyond the checklist. Those questions require suitable comparative measures and outcome results, which are not reported in the registry record.
The outcome description also notes that the company no longer exists and no longer has access to the collected data, and that only information from a draft publication is available. Consequently, the registry record does not provide the primary outcome counts, their uncertainty, or an estimate of how game data corresponded to checklist categories. The endpoint definition is available, but its observed results are not reported.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary endpoint but does not report its observed counts or any numerical analysis results. It is therefore not possible to describe the size, direction, or precision of an observed difference between the ADHD and control groups, or to assess whether game-derived information aligned with checklist classifications. No conclusion about the predictive performance of Groundskeeper can be drawn from the endpoint definition alone.
The endpoint is a count of participants meeting a symptom threshold for ADHD types. A count may describe the frequency of a classification in a group, but interpretation would also depend on the group denominator and on how the classification was assessed. The registry record does not report the primary outcome counts, group-specific denominators for that outcome, uncertainty intervals, or the relevant analysis details. It also does not report sensitivity, specificity, predictive values, or another measure of classification performance.
The design further limits interpretation of any group contrast. Allocation was non-randomized, and the registry record explicitly cautions that the arms are not a like-for-like control comparison. The arm descriptions refer to age- and gender-matched controls, but the record does not explain the matching procedure or how it was handled analytically. Matching as described does not establish that groups were comparable on other characteristics that could affect game behavior or checklist results.
The record lists double masking, but does not identify who was masked or how masking was achieved. It also does not provide a statistical plan or analysis populations. Without those details and the outcome results, readers cannot evaluate potential bias, the treatment of incomplete observations, or the robustness of any analysis.
The study is marked completed, but completion status is not a substitute for posted results. The description that only information from a draft publication remains does not provide the missing estimates. The registry's adverse-event entry lists zero participants at risk and zero affected for the reported serious and other categories; with no participants listed as at risk, this entry does not establish that no adverse events occurred among study participants.
Overall, the available record documents a completed, non-randomized study using an interactive game and a symptom checklist endpoint. It does not provide numerical primary outcome results or the analysis information needed to quantify an association, prediction, or group difference. Conclusions should therefore remain limited to the registered design and endpoint description.
9. Statistical Methods Explained
The primary outcome is a binary classification summarized as a count: whether participants tested high, meaning 6 or more symptoms, for an ADHD type on the Adult ADHD DSM IV-TR Checklist. A count of participants with an event is a common way to report binary outcomes. To interpret such a count, readers generally also need the number assessed in each group, and often an estimate of uncertainty. Neither the observed outcome counts nor the outcome denominators are reported in the registry record.
What can a count tell us?
A count records how many participants meet a stated definition. It does not, on its own, show how common that classification is within a group, because the group size used in the analysis is also needed. A count also does not establish whether a screening or diagnostic tool classifies participants correctly. Evaluating classification performance generally requires comparing predicted classifications with a suitable reference and reporting relevant performance measures. The registry record identifies the checklist categories and threshold but does not report those comparisons or measures.
The primary endpoint lists a 10 minutes timeframe. The study description separately says the game would be played in 30 minute sessions. These are distinct descriptions in the registry record; it does not explain their relationship. This matters methodologically because an analysis needs a clearly defined observation window and a clear link between the recorded game data and the endpoint assessment. That linkage is not reported.
What does non-randomized allocation imply?
In general, random allocation helps balance measured and unmeasured characteristics across groups on average. A non-randomized comparison does not have that protection. Differences between groups may reflect ADHD status, other group characteristics, or how participants entered the study. The registry record says the arms are not a like-for-like control comparison. It describes age- and gender-matched controls, but does not report how matching was carried out or how it entered the statistical analysis. A methodologically appropriate analysis would need to consider the design and the question being asked; the registry record does not specify such a method.
Double masking is recorded, but masking is not fully described. In general, masking can reduce the influence of knowledge about group status on measurement or assessment. To assess that protection, readers need to know which people were masked and how masking was maintained. This information is not reported in the registry record.
What do the planning assumptions mean?
The record's planning approach is described as an illustration based on the observed effect, not as the study's own design. It specifies a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation, with planning scenarios for fractions of the observed effect. These are assumptions used for planning illustrations; they do not establish that the trial was designed with those assumptions or that the study achieved any particular power. Sample-size illustrations are planning quantities, not observed power.
In general, a significance level defines a threshold used in a specified testing procedure, while power concerns the chance of detecting an effect of a stated size under assumptions about the design and data. A sample-size calculation depends on the target effect, variability or event frequency, allocation, and analysis method. The registry record does not report the trial's own sample-size justification or statistical plan. It also does not report the observed primary outcome values needed to assess an effect estimate from the posted results.
For binary outcomes, event counts may be modeled with methods suited to the data and design. In general, over-dispersion occurs when the observed variability exceeds what a simple model assumes; accounting for it can affect uncertainty estimates. The registry record does not report a model, dispersion assessment, confidence interval, or inferential test for the primary endpoint. Therefore, no particular model or correction can be attributed to this study.
A confidence interval, in general, expresses the range of values compatible with an estimate under the assumptions of the method. Its width conveys precision: wider intervals indicate less precision. No primary outcome confidence interval is reported in the registry record. Without an estimate and its uncertainty, the magnitude and precision of any association or group contrast cannot be assessed.
The registry lists 3 outcome measures and 3 analyses. It does not report the analysis methods or whether the analyses correspond one-to-one with outcomes. Because the results and analysis plan are unavailable in the registry record, readers cannot evaluate model choice, multiplicity handling, or whether analyses were prespecified. Those limits make the design description informative, but not sufficient for reproducing or independently assessing the statistical analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 3 outcome measures and 3 analyses, but does not identify the outcomes and analyses in enough detail to determine their relationship. It does not report whether a primary analysis was prespecified beyond naming the primary endpoint, or whether any adjustment for multiple testing was planned or applied. When several outcomes or analyses are considered, multiplicity can increase the chance of at least one apparently unusual result under a null model. General methods for addressing this include adjusting the testing procedure or clearly designating primary and exploratory analyses. No such approach is reported in the registry record.
Missing-data methods are also not reported. The record does not state how incomplete checklist assessments, unavailable game records, or participants without an assessable outcome were handled. It does not report analysis populations or the number of participants contributing to the primary endpoint. Without these details, readers cannot assess whether the analyzed participants differed from those enrolled or how missing observations might affect results.
The record notes that the company no longer exists and no longer has access to data collected, and that only information from a draft publication is available. Numerical endpoint results and supporting analysis details are not reported in the registry record. Consequently, the extent of missing outcome information and the consequences for statistical inference cannot be evaluated.
11. What the Result Does, and Does Not, Mean
The record supports a description of the intended study question and design: adults with ADHD and controls played Groundskeeper on Sifteo cubes, and the primary endpoint counted participants meeting a checklist symptom threshold by ADHD type. It also documents a completed, parallel, non-randomized, double-masked study with enrollment of 18.
It does not show how many participants met the endpoint, how results differed between groups, or how precisely any estimate was measured. The registry record does not report numerical primary outcome results, uncertainty intervals, or measures of classification performance. As a result, it cannot establish whether game data predicted checklist status or how well the game distinguished symptom categories.
The design description also does not support a causal interpretation of a group contrast. Allocation was non-randomized, and the record cautions that the arms are not a like-for-like control comparison. The age- and gender-matching description does not by itself resolve potential differences between groups, and the analysis method for matching is not reported.
These limits do not mean the game performed well or poorly. They mean that the posted registry information is insufficient to assess performance or draw a statistical conclusion about the primary question. The endpoint definition and design details are available, but the outcome evidence required to answer the question is not reported in the registry record.
12. Why This Trial Matters Statistically
This study raises a statistical question about whether an interactive, motion-sensitive game can provide information related to ADHD symptoms beyond responses to a checklist. The brief description highlights a general measurement issue: conventional computer-based tasks may not capture accessory movements such as restlessness, while reading demands or subjective reporting can affect other assessments. The study's use of Sifteo cubes and Groundskeeper is intended to bring movement-sensitive interaction into that context.
Statistically, however, a plausible measurement concept and a defined endpoint are not evidence of predictive performance. The endpoint counts participants meeting a checklist threshold; assessing prediction would require results connecting the game data to those checklist classifications, with appropriate measures of performance and uncertainty. Those results are not reported in the registry record.
The study also illustrates why design details matter. Non-randomized allocation can leave group differences entangled with characteristics other than the condition of interest. Matching is mentioned, but the matching method and analysis are not reported. Masking is recorded, but who was masked is not specified. Such omissions make it difficult to assess bias even before considering the absence of outcome estimates.
The record is therefore useful for understanding the proposed measurement question and the limits of the available evidence. It identifies a completed study and a primary endpoint, while leaving the statistical findings unavailable. That distinction is important: a registered question and an endpoint definition are not a substitute for posted results.
13. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
A central limitation is that the registry record does not report numerical primary outcome results, despite identifying the endpoint. The record states that the company no longer exists and no longer has access to data collected, with only information from a draft publication available. Consequently, the outcome counts, denominators, uncertainty estimates, and analysis needed to assess the primary question are unavailable in the registry record.
The endpoint is a checklist-based symptom classification, not a reported measure of game accuracy or predictive performance. The registry record does not explain how the game data were linked to checklist classifications, nor does it report diagnostic or prediction performance measures. The primary endpoint's 10 minutes timeframe and the brief description's 30 minute game sessions are both recorded, but their relationship is not explained.
The allocation is non-randomized, and the registry record explicitly warns that the arms are not a like-for-like control comparison. Although the arm descriptions refer to age- and gender-matched controls, the record does not describe how matching was done or analyzed. The double-masked designation is not accompanied by details about who was masked. Recruitment, eligibility criteria, participant flow, analysis populations, and the treatment of missing data are not reported.
The registry lists 3 outcome measures and 3 analyses but does not describe the statistical methods or multiplicity handling. It does not report a trial-specific sample-size justification or interim-analysis plan. These gaps, together with the unavailable outcome data, limit independent assessment, reproducibility, and interpretation of the study.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices in Adults — NCT02127931.
- Registry record last updated 2020-01-14; status last verified 2020-01.
- Results first posted 2020-01-14.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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17. Record Summary
NCT02127931 is a completed study sponsored by CogCubed, Corp, with enrollment of 18. The registry records a parallel, non-randomized, double-masked design and lists the phase as NA. The recorded start is 2014-03, and primary completion is 2016-12-01.
Participants in both the ADHD and control groups played Groundskeeper on Sifteo cubes. The primary endpoint counts participants with 6 or more symptoms by ADHD type on the Adult ADHD DSM IV-TR Checklist, with a listed timeframe of 10 minutes. The record describes the game as intended for adults aged 18 and over and refers to 30 minute sessions.
The registry record does not report numerical primary outcome results or statistical analysis details. It notes that the company no longer exists and no longer has access to the collected data, and that only information from a draft publication is available. The record also cautions that the non-randomized arms are not a like-for-like control comparison.