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The purpose of this study is to investigate QbMobile ability to collect and provide accurate and objective data which can be used to facilitate assessment and treatment procedures for ADHD in a clinical setting as well as remotely.
This study aims to evaluate the performance of QbMobile in children, adolescents, and adults from the normative population, those referred for an initial ADHD assessment, and individuals with an ADHD diagnosis who are not currently receiving ADHD 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.
For participants referred for an ADHD assessment or a has an ADHD diagnosis, QbMobile must be completed prior to initiating any ADHD treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| This single cohort includes subjects with and without ADHD. | Eligible participants that do not have a documented or suspected current or lifetime diagnosis of ADHD will be recruited from the general population using different recruitment activities (letters, posted flyers, etc.). Eligible participants being referred for their initial assessment or have a diagnosis of ADHD 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 |
|---|---|---|---|---|
| QbMobile | Device | QbMobile is a software application that can be installed on a smartphone device used to measure activity, attention, impulsivity, and movement patterns in participants over a two-day period. |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized QbMobile Scores of the four parameters: Attention, Impulsivity, Activity, and Movement Patterns. | QbMobile generates standardized scores (SD-scores) for attention, impulsivity, activity, and movement patterns using age and sex at birth adjusted norms. These scores provide objective data collected during the 10-minute test session and are automatically included in a standardized report generated immediately upon test completion. This supports evaluation of test validity for ADHD-related symptom measurement. | 10-minute testing period |
| Measure | Description | Time Frame |
|---|---|---|
| QbMobile ADHD Symptom Likelihood Score Across Diagnostic Groups | QbMobile Total score (0-100 where 0 indicates a low likelihood of exhibiting ADHD symptoms and 100 indicates a high likelihood of exhibiting ADHD symptoms) will be compared across participants assessed for ADHD, diagnosed but untreated, and normative participants to evaluate differentiation in ADHD symptom likelihood. This score is automatically generated in the QbMobile report upon test completion. |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prodigy Psychiatric Group | San Jose | California | 95138 | United States | ||
| Bokhari Medical Consortium |
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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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 10 minute testing period |
| Comparison of QbMobile SD-Scores Across Testing Environments | SD-scores for attention, impulsivity, activity, and movement patterns will be compared between in-clinic and remote QbMobile tests to assess consistency and reliability. | Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2) |
| Exploratory Identification of Novel QbMobile Derived Parameters Reflecting Activity, Movement, Attention, and Impulsivity | Exploratory analyses will be conducted on raw QbMobile data collected at Visit 1 and Visit 2 to identify potential additional parameters that may serve as indices of activity, attention, impulsivity, and movement. These parameters will be evaluated for their potential association with ADHD symptomatology. | QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2). |
| Largo |
| Florida |
| 33770 |
| United States |
| Nona Pediatric Center | Orlando | Florida | 32832 | United States |