Attention Deficit Hyperactivity Disorder (ADHD), Healthy Volunteer, No History of ADHD
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEQbMobile
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.
Sponsors
Qbtech AB
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 60 Years
Healthy volunteers
Yes
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; * Have no documented or suspected current or lifetime diagnosis of ADHD or referred for an initial assessment for ADHD or have a diagnosis of ADHD but not currently receiving treatment; * Meet 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 the past 7 days prior to Visit 1; * A current 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 tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized QbMobile Scores of the four parameters: Attention, Impulsivity, Activity, and Movement Patterns. | 10-minute testing period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QbMobile ADHD Symptom Likelihood Score Across Diagnostic Groups | 10 minute testing period | 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. |
| Comparison of QbMobile SD-Scores Across Testing Environments | Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2) | SD-scores for attention, impulsivity, activity, and movement patterns will be compared between in-clinic and remote QbMobile tests to assess consistency and reliability. |
| Exploratory Identification of Novel QbMobile Derived Parameters Reflecting Activity, Movement, Attention, and Impulsivity | QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2). | 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. |
Countries
United States
Outcome results
None listed