<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01711372</url>
  </required_header>
  <id_info>
    <org_study_id>131209-12</org_study_id>
    <nct_id>NCT01711372</nct_id>
  </id_info>
  <brief_title>Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices</brief_title>
  <official_title>Predictive Executive Functioning Models Using Interactive Tangible-Graphical Interface Devices, Phase 2 Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CogCubed, Corp</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CogCubed, Corp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A new company called CogCubed has created a new game based on the Sifteo Cube&#xD;
      (http://www.sifteo.com) platform. These new hands-on digitized cubes are unique,&#xD;
      motion-sensitive wireless blocks that contain multiple sensors that can interact with one&#xD;
      another. CogCubed is providing the data for this study. The game will be played in a 30&#xD;
      minute sessions by subjects ages 6-17. Subjects recruited to play the game will be those with&#xD;
      ADHD and those without, matched by gender and age. Those with comorbidities of developmental&#xD;
      delay, mental retardation, psychosis, schizophrenia, bipolar disorder and substance use&#xD;
      disorders will be excluded, as well as any physiological disability that affects upper limb&#xD;
      movement and/or coordination. Informed consent will be obtained from parents and patient&#xD;
      prior to administering the game. Parents will fill out a Conner's Brief Rating Scale and a&#xD;
      Conner's Brief Rating Scale, Teacher's version will also be supplied to be filled out at&#xD;
      school. The hypothesis is that by analyzing data generated from this new gaming platform&#xD;
      named Sifteo for which a game was created, which uses auditory and visual stimuli and&#xD;
      distracters, the investigators expect that they will be able to provide a more accurate&#xD;
      profile of impulsivity and inattention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current diagnostic aids used in treating ADHD are currently expensive, time intensive, and&#xD;
      provide little information about accessory movements in response to a stimulus. One in ten&#xD;
      children, ages 5 to 17, has been diagnosed with ADHD.&#xD;
&#xD;
      Tests such as the Conners' Rating Scale require subjective responses from parents and&#xD;
      teachers, making coordination difficult. The computerized Conners' Continuous Performance&#xD;
      Test (CPT) provides objective data in regards to inattention and impulsive patterns of&#xD;
      response. However, it does not provide data regarding accessory movements such as&#xD;
      restlessness, hyperactivity, and other inappropriate movements. If the subject taking the&#xD;
      exam has a reading disorder, it will impair his or her ability to respond accurately and it&#xD;
      will increase response time. The T.O.V.A. is another computer based test used as a diagnostic&#xD;
      aid for ADHD, which uses a microswitch to record responses. It does utilize auditory and&#xD;
      visual stimuli, which removes the reading level limitation. However, it is unable to measure&#xD;
      to measure accessory movements that may be contributing to reaction time and errors of&#xD;
      omission and commission.&#xD;
&#xD;
      Because of these limitations, a new company called CogCubed has created a new game based on&#xD;
      the Sifteo Cube (http://www.sifteo.com) platform. These new hands-on digitized cubes are&#xD;
      unique, motion-sensitive wireless blocks that contain multiple sensors that can interact with&#xD;
      one another. CogCubed is providing the data for this study. The game will be played in a 30&#xD;
      minute sessions by subjects ages 6-17. Subjects recruited to play the game will be those with&#xD;
      ADHD and those without, matched by gender and age. Those with comorbidities of developmental&#xD;
      delay, mental retardation, psychosis, schizophrenia, bipolar disorder and substance use&#xD;
      disorders will be excluded, as well as any physiological disability that affects upper limb&#xD;
      movement and/or coordination. Informed consent will be obtained from parents and patient&#xD;
      prior to administering the game. Parents will fill out a Conner's Brief Rating Scale and a&#xD;
      Conner's Brief Rating Scale, Teacher's version will also be supplied to be filled out at&#xD;
      school.&#xD;
&#xD;
      The hypothesis is that by analyzing data generated from this new gaming platform named Sifteo&#xD;
      for which a game was created, which uses auditory and visual stimuli and distracters, the&#xD;
      investigators expect that they will be able to provide a more accurate profile of impulsivity&#xD;
      and inattention. The investigators expect that inattention will have more errors of omission&#xD;
      and less tilt movements than control and impulsivity will be represented as more commission&#xD;
      and greater tilting movements than control. This trial builds on the previous results of our&#xD;
      phase 1 trials used to create the predictive algorithms to analyze the data and predict the&#xD;
      likelihood of ADHD diagnosis based on patterns of game play behavior.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Actual">December 5, 2016</completion_date>
  <primary_completion_date type="Actual">December 5, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The person having the patient play the came did not know if the patient had ADHD or not.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game</measure>
    <time_frame>30 minutes</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)</measure>
    <time_frame>30 minutes</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)</measure>
    <time_frame>30 minutes</time_frame>
    <description>CPT measures sustained attention. Participants were asked to press the space bar whenever any letter except the letter &quot;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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>Controls who played Groundskeeper game</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probands played groundskeeper game</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Groundskeeper game for controls</intervention_name>
    <description>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.</description>
    <arm_group_label>Controls who played Groundskeeper game</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Groundskeeper game for ADHD</intervention_name>
    <description>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.</description>
    <arm_group_label>Probands played groundskeeper game</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 6-17, males and females&#xD;
&#xD;
          -  Individuals with ADHD&#xD;
&#xD;
          -  Individuals without ADHD&#xD;
&#xD;
          -  Depressive Disorders&#xD;
&#xD;
          -  Anxiety Disorders&#xD;
&#xD;
          -  Oppositional Defiant Disorder&#xD;
&#xD;
          -  Panic Disorder&#xD;
&#xD;
          -  Eating Disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Developmental Delay&#xD;
&#xD;
          -  IQ below 70&#xD;
&#xD;
          -  Low functioning Autism Spectrum Disorders&#xD;
&#xD;
          -  Psychosis&#xD;
&#xD;
          -  Substance Use Disorders&#xD;
&#xD;
          -  Medical comorbidities that involve any motoric disability that affects upper-limb&#xD;
             movement and/or strength&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monika D Roots, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CogCubed, Corp</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaideep Srivastava, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CogCubed, Corp</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groves Academy</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Egli Assessment</name>
      <address>
        <city>Waconia</city>
        <state>Minnesota</state>
        <zip>55387</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>27105181</PMID>
  </results_reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <results_first_submitted>January 26, 2016</results_first_submitted>
  <results_first_submitted_qc>November 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 3, 2019</results_first_posted>
  <last_update_submitted>November 12, 2019</last_update_submitted>
  <last_update_submitted_qc>November 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADHD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>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.</recruitment_details>
      <pre_assignment_details>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.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>ADHD Group</title>
          <description>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.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The patients who completed all screening tests and intervention for this trial were 113 patients. Company no longer exists. Only information in published study results available.</population>
      <group_list>
        <group group_id="B1">
          <title>ADHD Group</title>
          <description>Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities.&#xD;
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.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Controls played a go/no go task on Sifteo Cubes to asses for attentional capabilities.&#xD;
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.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="66"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="113"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Psychiatric Disorders</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Anxiety Disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mood Disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disruptive Behavior Disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Autism Spectrum Disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reading Disability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game</title>
        <description>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).</description>
        <time_frame>30 minutes</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants in the Study With and Without ADHD</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game</title>
          <description>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).</description>
          <population>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.</population>
          <units>Proportion of accurate ADHD Diagnoses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>AUC or ROC for Groundskeeper Game</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>AUC of ROC is 0.78</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)</title>
        <description>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).</description>
        <time_frame>30 minutes</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants in the Study With and Without ADHD</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)</title>
          <description>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).</description>
          <population>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.</population>
          <units>Proportion of accurate ADHD Diagnoses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <other_analysis_desc>AUC of ROC. Proportion of accurate ADHD diagnoses is 0.76</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)</title>
        <description>CPT measures sustained attention. Participants were asked to press the space bar whenever any letter except the letter &quot;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).</description>
        <time_frame>30 minutes</time_frame>
        <population>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.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants in the Study With and Without ADHD</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)</title>
          <description>CPT measures sustained attention. Participants were asked to press the space bar whenever any letter except the letter &quot;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).</description>
          <population>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.</population>
          <units>Proportion of accurate ADHD Diagnoses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>AUC of ROC</non_inferiority_desc>
            <other_analysis_desc>AUC of ROC. Proportion of accurate ADHD diagnosis is 0.62</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Company no longer exits. Only information in published study results available. No information available on monitoring/frequency of Adverse Events</time_frame>
      <desc>Company no longer exits. Only information in published study results available. No information available on monitoring/frequency of Adverse Events</desc>
      <group_list>
        <group group_id="E1">
          <title>ADHD Group</title>
          <description>Patient with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities.&#xD;
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.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Patient with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities.&#xD;
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.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>00</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Monika Roots, Chief Medical Officer</name_or_title>
      <organization>CogCubed</organization>
      <phone>6173082009</phone>
      <email>monika@cogcubed.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01711372
org study id: 131209-12
nct id: NCT01711372
lead sponsor: 
has dmc: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Screening
masking: Double (Investigator, Outcomes Assessor)
masking description: The person having the patient play the came did not know if the patient had ADHD or not.
measure: Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game
time frame: 30 minutes
description: 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).
measure: Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)
time frame: 30 minutes
description: 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).
measure: Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)
time frame: 30 minutes
description: 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).
arm group label: Controls who played Groundskeeper game
arm group type: Placebo Comparator
description: Controls played a go/no go task on Sifteo cubes to asses for attentional capabilities.
arm group label: Probands played groundskeeper game
arm group type: Active Comparator
description: Patients with ADHD played a go/no go task on Sifteo cubes to asses for attentional capabilities
intervention type: Device
intervention name: Groundskeeper game for controls
description: 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.
arm group label: Controls who played Groundskeeper game
intervention type: Device
intervention name: Groundskeeper game for ADHD
description: 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.
arm group label: Probands played groundskeeper game
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Monika D Roots, MD
role: Principal Investigator
affiliation: CogCubed, Corp
last name: Jaideep Srivastava, PhD
role: Principal Investigator
affiliation: CogCubed, Corp
facility: 
facility: 
country: United States
citation: 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
responsible party type: Sponsor
mesh term: Attention Deficit Disorder with Hyperactivity
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 