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The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.
This study aims to evaluate the performance of QbMobile in children, adolescents, and adults assessed for and diagnosed with ASD (Autism Spectrum Disorder, MDD (Major Depressive Disorder), Bipolar Disorder, or Anxiety Disorder, or has a prior diagnosis of one of the included disorders but is not currently receiving treatment. Participants will complete the 10-minute QbMobile test on their personal device during a scheduled clinical visit. They will then repeat the test remotely the following day at the same time as the previous test +/-3 hours. Participants will be asked to complete QbMobile prior to initiating any treatment.
Note on Outcome Measures Presentation:
The IRB-approved protocol defines endpoints broadly (e.g., identification of QbMobile domain profiles, classification accuracy, variability, and exploratory analyses). To comply with ClinicalTrials.gov requirements that each outcome measure represent a single assessment with a single unit of measure, these endpoints are operationalized into separate outcome measures corresponding to individual QbMobile metrics (domain SD-scores, Total Score [0-100], accuracy percentages, variability estimates).
This operationalization does not introduce new scientific endpoints or alter study objectives, design, or analyses. It ensures clarity and compliance for registry reporting while maintaining alignment with the approved protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASD | Eligible participants being referred for their initial assessment or have a diagnosis of ASD but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment. |
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| Bipolar disorder | Eligible participants being referred for their initial assessment or have a diagnosis of Bipolar Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment. |
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| MDD | Eligible participants being referred for their initial assessment or have a diagnosis of MDD but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment. |
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| Separation Anxiety Disorder | Eligible participants being referred for their initial assessment or have a diagnosis of Separation Anxiety Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) | Device | Participants will complete two non-invasive, 10-minute digital tests using the QbMobile Investigational Device-one at the clinic and one at home the following day. The tests objectively measure cognitive performance and activity levels and will not influence clinical diagnosis or treatment in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of QbMobile Domain Profiles Using SD-Scores and Total Score (0-100) | QbMobile is a software application that measures cognitive performance and activity levels, including attention, impulsivity, activity, and movement patterns. The study will identify statistically distinct QbMobile domain profiles for each diagnostic group (ASD, MDD, Bipolar Disorder, Anxiety Disorder) using domain SD-scores and the QbMobile Total Score (0-100). (Component metrics are listed as secondary outcomes to meet single-measure reporting requirements.) | Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2) |
| Measure | Description | Time Frame |
|---|---|---|
| QbMobile Domain SD-Scores (Attention, Impulsivity, Activity, Movement) - Group Differences | QbMobile is a software application that measures cognitive performance and activity levels. Domain scores will be analyzed as SD-scores to assess differences among diagnostic groups (ASD, MDD, Bipolar Disorder, Anxiety Disorder). | Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2) |
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Inclusion Criteria:
Exclusion Criteria:
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Potential study participants who meet the eligibility criteria will be identified through referrals and recruitment efforts at the participating study sites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Nolen | Contact | 18325370300 | robert.nolen@qbtech.com | |
| Ragini Sanyal | Contact | ragini.sanyal@qbtech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCM Clinical Research Group | Recruiting | Miami | Florida | 33133 | United States |
Due to the nature of the research, limited access to supporting data may be granted upon reasonable request under confidentiality agreements from the corresponding sponsor.
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| Social Anxiety Disorder | Eligible participants being referred for their initial assessment or have a diagnosis of Social Anxiety Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment. |
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| Generalized Anxiety Disorder | Eligible participants being referred for their initial assessment or have a diagnosis of Generalized Anxiety Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment. |
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| QbMobile Total Score (0-100) - Group Differences | QbMobile is a software application that measures cognitive performance and activity levels. The Total Score (0-100; higher values indicate greater likelihood of ADHD symptomatology) will be compared across diagnostic groups to assess differences. | Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2) |
| Classification Accuracy Using QbMobile Domain SD-Scores | QbMobile is a software application that measures cognitive performance and activity levels. Classification accuracy among diagnostic groups will be evaluated using domain SD-scores; metrics will include sensitivity, specificity, and predictive values. | Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2) |
| Classification Accuracy Using QbMobile Total Score (0-100) | QbMobile is a software application that measures cognitive performance and activity levels. Classification accuracy among diagnostic groups will be evaluated using the Total Score; metrics will include sensitivity, specificity, and predictive values based on prespecified thresholds. | QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2) |
| Comparison of QbMobile Domain SD-Scores with Normative Dataset | QbMobile is a software application that measures cognitive performance and activity levels. Domain SD-scores will be compared with the age- and sex-adjusted normative dataset to identify differences between diagnostic groups and normative patterns. | Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2). |
| Comparison of QbMobile Total Score (0-100) with Normative Distribution | QbMobile is a software application that measures cognitive performance and activity levels. Total Scores will be compared with the normative distribution to identify deviations from expected values. | Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2). |
| Variability in Differentiation Using QbMobile Domain SD-Scores | QbMobile is a software application that measures cognitive performance and activity levels. Variability in group differentiation will be assessed using domain SD-scores (e.g., confidence intervals and variance estimates across repeated measures). | Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2). |
| Variability in Differentiation Using QbMobile Total Score (0-100) | QbMobile is a software application that measures cognitive performance and activity levels. Variability will be assessed using Total Scores (e.g., confidence intervals and variance estimates across repeated measures). | QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2). |
| Exploratory Analysis of Additional QbMobile Domain Parameters (SD-Based) | Consistent with the protocol statement that "all data collected from QbMobile during this study will be available to explore additional domain parameters," exploratory analyses will examine QbMobile domain data using SD-based metrics to identify additional parameters for further analysis. | QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2). |
| Exploratory Analysis of Additional QbMobile Parameters from Total Score and Raw Performance Data | Consistent with the protocol statement that "all data collected from QbMobile… will be available to explore additional domain parameters," exploratory analyses will use the QbMobile Total Score (0-100) and raw performance data (e.g., response time, error counts, movement traces) to identify additional parameters for further analysis. | Visit 1 (clinic) and Visit 2 (remote, next day). |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000067877 | Autism Spectrum Disorder |
| D001010 | Anxiety, Separation |
| D000072861 | Phobia, Social |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001008 | Anxiety Disorders |
| D010698 | Phobic Disorders |
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