An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms

Official title

An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms.

Overview

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.

Detailed description

This study aims to evaluate the performance of QbMobile in children, adolescents, and adults assessed for and diagnosed with ASD (Autism Spectrum Disorder, MDD (Major Depressive Disorder), Bipolar Disorder, or Anxiety Disorder, or has a prior diagnosis of one of the included disorders but is not currently receiving 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. Participants will be asked to complete QbMobile prior to initiating any treatment.

Note on Outcome Measures Presentation:

The IRB-approved protocol defines endpoints broadly (e.g., identification of QbMobile domain profiles, classification accuracy, variability, and exploratory analyses). To comply with ClinicalTrials.gov requirements that each outcome measure represent a single assessment with a single unit of measure, these endpoints are operationalized into separate outcome measures corresponding to individual QbMobile metrics (domain SD-scores, Total Score \[0-100\], accuracy percentages, variability estimates).

This operationalization does not introduce new scientific endpoints or alter study objectives, design, or analyses. It ensures clarity and compliance for registry reporting while maintaining alignment with the approved protocol.

Interventions

• Device Digital software application for cognitive performance and activity measurement (QbMobile, investigational device)
  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.

Primary outcome measures

• Identification of QbMobile Domain Profiles Using SD-Scores and Total Score (0-100) [Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)]

Secondary outcome measures (10)

• QbMobile Domain SD-Scores (Attention, Impulsivity, Activity, Movement) - Group Differences [Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)]
• QbMobile Total Score (0-100) - Group Differences [Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)]
• Classification Accuracy Using QbMobile Domain SD-Scores [Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)]
• Classification Accuracy Using QbMobile Total Score (0-100) [Time frame: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2)]
• Comparison of QbMobile Domain SD-Scores with Normative Dataset [Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).]
• Comparison of QbMobile Total Score (0-100) with Normative Distribution [Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).]
• Variability in Differentiation Using QbMobile Domain SD-Scores [Time frame: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).]
• Variability in Differentiation Using QbMobile Total Score (0-100) [Time frame: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).]
• Exploratory Analysis of Additional QbMobile Domain Parameters (SD-Based) [Time frame: QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).]
• Exploratory Analysis of Additional QbMobile Parameters from Total Score and Raw Performance Data [Time frame: Visit 1 (clinic) and Visit 2 (remote, next day).]

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;
• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

United States · 1 center

• CCM Clinical Research Group — Miami

Identifiers

NCT: NCT07329673 · Pro00090568 QB25-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗