An Examination of the Performance of QbMobile in Differential Diagnosis Associated With ADHD Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Identification of QbMobile Domain Profiles Using SD-Scores and Total Score (0-100)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) (Device)
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.
干预措施: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) (Device)
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.
干预措施: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) (Device)
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.
干预措施: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) (Device)
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.
干预措施: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) (Device)
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.
干预措施: Digital software application for cognitive performance and activity measurement (QbMobile, investigational device) (Device)
结局指标
主要结局
Identification of QbMobile Domain Profiles Using SD-Scores and Total Score (0-100)
时间窗: Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2)
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.)
次要结局
- 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).)
- Comparison of QbMobile Total Score (0-100) with Normative Distribution(Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).)
- Variability in Differentiation Using QbMobile Domain SD-Scores(Two QbMobile tests: at the clinic (Visit 1) and remotely the following day (Visit 2).)
- Variability in Differentiation Using QbMobile Total Score (0-100)(QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).)
- Exploratory Analysis of Additional QbMobile Domain Parameters (SD-Based)(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(Visit 1 (clinic) and Visit 2 (remote, next day).)