Attention Deficit Disorder (ADD), Attention Deficit Disorder With Hyperactivity (ADHD)
Conditions
Brief summary
The current study will investigate if QbMobile can be used to improve the accuracy and objective identification of reduced ADHD symptoms in tests scores once treatment has been initiated.
Detailed description
This 4-week study will evaluate QbMobile's performance in monitoring ADHD treatment response. 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 before beginning their ADHD medication treatment. At week 2 and week 4, participants will take QbMobile remotely at least 1 hour after taking their ADHD medication and no longer than 4 hours post dose.
Interventions
OTHERobservational study
observational study
Sponsors
Qbtech AB
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent (including parent/legal guardians consent when this is required for individuals under 18 years old and assent as is required based on the age of participant) for QbMobile; * Aged \> 6 years and \< 60 years old; * Referred for an ADHD assessment or has a diagnosis of ADHD but not currently receiving any type of stimulant or nonstimulant medication treatment; * Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactivity/impulsive presentation) per sites standard clinical care evaluation; * Qbtech Rating Scale total score of \>24 at Visit 1; * Have adequate sensory and physical ability to complete QbMobile; * Possess or has access to an iPhone model that supports QbMobile.
Exclusion criteria
* Intellectual disability designated by IQ\<75); * Has used psychostimulant medication within 7 days prior to Visit 1; * A concurrent medical diagnosis that could significantly affect test performance (brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g., vascular dementia, Alzheimer disease, etc); * Other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain); * Substance use (e.g., alcohol, drugs) that may affect performance on the day of the test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in QbMobile Total Score from Baseline at Visit 3 and Visit 4 | Baseline, Visit 3 (Week 2), and Visit 4 (Week 4) | Change in the QbMobile Total Score from baseline (Visit 2) will be assessed at Visit 3 and Visit 4 to evaluate treatment related responses over time. The QbMobile produces a Total Score number ranging from 0 to 100, where 0 indicates a low likelihood of exhibiting ADHD symptoms and 100 indicates a high likelihood of exhibiting ADHD symptoms. This score is automatically generated in a standard report immediately upon completion of QbMobile. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QbMobile SD-scores from Baseline at Visit 3 and Visit 4 | Baseline, Visit 3 (Week 2), and Visit 4 (Week 4) | Change in the QbMobile SD-scores (Standard Deviation scores) from baseline (Visit 2) will be assessed at Visit 3 and Visit 4 to evaluate treatment-related effects over time. QbMobile SD-scores are standardized metrics derived from the main parameters (attention, impulsivity, activity and movement). These scores are calculated using and age and sex at birth adjusted normative dataset. The SD-scores are produced in the QbMobile report generated after completion of QbMobile. |
Countries
United States
Outcome results
None listed