An Investigational Study Examining the Efficacy of QbMobile in Treatment Monitoring in Individuals With ADHD

NCT07217977 | Enrolling By Invitation

• 1 other identifier: 00082513/QB24-02
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 7

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.

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD); Attention Deficit Disorder (ADD)

Outcome Measures

Primary Outcomes (1)

• Change in QbMobile Total Score from Baseline at Visit 3 and Visit 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.

  Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)

Secondary Outcomes (1)

• Change in QbMobile SD-scores from Baseline at Visit 3 and Visit 4

  Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)

Study Arms (1)

ADHD

Other: observational study

Interventions

observational study OTHER

observational study

ADHD

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from referrals or participating site's ADHD data base.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qbtech AB: lead

Study Sites (7)

Focus-MD

Mobile, Alabama, 36607, United States

Location

Prodigy Psychiatric Group

San Jose, California, 95138, United States

Location

Bokhari Medical Consortium

Largo, Florida, 33770, United States

Location

CCM Clinical Research Group

Miami, Florida, 33133, United States

Location

Nona Pediatric Center

Orlando, Florida, 32829, United States

Location

Godwin Psychiatry

Goldsboro, North Carolina, 27534, United States

Location

MindWell Urgent Care

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Observation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 20, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)