An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QbMobile.
- Who it may be relevant to
- Registry conditions: No History of ADHD, Attention Deficit Hyperactivity Disorder (ADHD), Healthy Volunteer. Basic parameters: 6 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device QbMobile
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.
Primary outcome measures
- Standardized QbMobile Scores of the four parameters: Attention, Impulsivity, Activity, and Movement Patterns. [Time frame: 10-minute testing period]
Secondary outcome measures (3)
- QbMobile ADHD Symptom Likelihood Score Across Diagnostic Groups [Time frame: 10 minute testing period]
- Comparison of QbMobile SD-Scores Across Testing Environments [Time frame: 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 [Time frame: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Prodigy Psychiatric Group — San Jose
- Bokhari Medical Consortium — Largo
- Nona Pediatric Center — Orlando
Identifiers
NCT: NCT07220330 · 00082479 / QB24-01