An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations

An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations

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.

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.