An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms
1 other identifier
observational
300
1 country
1
Brief Summary
The purpose of this study is to evaluate QbMobile's ability to collect objective data to identify specific symptom profiles in differential diagnoses (ASD, MDD, Bipolar Disorder and Anxiety Disorder) that are common with ADHD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
May 6, 2026
May 1, 2026
10 months
December 11, 2025
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of QbMobile Domain Profiles Using SD-Scores and Total Score (0-100)
QbMobile is a software application that measures cognitive performance and activity levels, including attention, impulsivity, activity, and movement patterns. The study will identify statistically distinct QbMobile domain profiles for each diagnostic group (ASD, MDD, Bipolar Disorder, Anxiety Disorder) using domain SD-scores and the QbMobile Total Score (0-100). (Component metrics are listed as secondary outcomes to meet single-measure reporting requirements.)
Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
Secondary Outcomes (10)
QbMobile Domain SD-Scores (Attention, Impulsivity, Activity, Movement) - Group Differences
Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
QbMobile Total Score (0-100) - Group Differences
Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
Classification Accuracy Using QbMobile Domain SD-Scores
Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
Classification Accuracy Using QbMobile Total Score (0-100)
QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2)
Comparison of QbMobile Domain SD-Scores with Normative Dataset
Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).
- +5 more secondary outcomes
Study Arms (6)
ASD
Eligible participants being referred for their initial assessment or have a diagnosis of ASD but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
Bipolar disorder
Eligible participants being referred for their initial assessment or have a diagnosis of Bipolar Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
MDD
Eligible participants being referred for their initial assessment or have a diagnosis of MDD but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
Separation Anxiety Disorder
Eligible participants being referred for their initial assessment or have a diagnosis of Separation Anxiety Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
Social Anxiety Disorder
Eligible participants being referred for their initial assessment or have a diagnosis of Social Anxiety Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
Generalized Anxiety Disorder
Eligible participants being referred for their initial assessment or have a diagnosis of Generalized Anxiety Disorder but currently not receiving treatment who are attending a clinic visit at study sites will be approached by a clinic research staff about the study or contacted prior to their appointment.
Interventions
Participants will complete two non-invasive, 10-minute digital tests using the QbMobile Investigational Device-one at the clinic and one at home the following day. The tests objectively measure cognitive performance and activity levels and will not influence clinical diagnosis or treatment in this study.
Eligibility Criteria
Potential study participants who meet the eligibility criteria will be identified through referrals and recruitment efforts at the participating study sites.
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 initial assessment for ASD, MDD, Bipolar Disorder or Anxiety Disorder (Separation Anxiety Disorder, Social Anxiety Disorder, Generalized Anxiety Disorder (GAD)) or has a prior diagnosis of one of the included disorders but is not currently receiving treatment;
- Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ASD, MDD, Bipolar Disorder or Anxiety Disorder per sites standard clinical procedures;
- Have adequate sensory and physical ability to complete QbMobile;
- Possess or have access to an iPhone model that supports QbMobile.
You may not qualify if:
- Intellectual disability designated by IQ\<70;
- Has a DSM-5 or ICD-11 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder;
- Has a primary diagnosis of ADHD (combined, inattentive, or hyperactivity/impulsive presentation);
- Has a concurrent medical diagnosis that could significantly affect test performance such as brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g. vascular dementia, Alzheimer disease, etc);
- Has other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);
- Use of prescription medications (e.g., anxiolytics, sedative medications) taken on the day before completing QbMobile that could significantly affect performance;
- Substance use (e.g., alcohol, drugs) that may affect performance on the day of the tests.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qbtech ABlead
Study Sites (1)
CCM Clinical Research Group
Miami, Florida, 33133, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2025
First Posted
January 9, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Due to the nature of the research, limited access to supporting data may be granted upon reasonable request under confidentiality agreements from the corresponding sponsor.