An Investigational Study Examining the Cross-Validation of QbMobile in ADHD and Normative Populations
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 700
- 试验地点
- 5
- 主要终点
- Standardized QbMobile Scores of the four parameters: Attention, Impulsivity, Activity, and Movement Patterns.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
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;
- •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.
排除标准
- •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.
研究组 & 干预措施
This single cohort includes subjects with and without ADHD.
Eligible participants that do not have a documented or suspected current or lifetime diagnosis of ADHD will be recruited from the general population using different recruitment activities (letters, posted flyers, etc.).
Eligible participants being referred for their initial assessment or have a diagnosis of ADHD 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: QbMobile (Device)
结局指标
主要结局
Standardized QbMobile Scores of the four parameters: Attention, Impulsivity, Activity, and Movement Patterns.
时间窗: 10-minute testing period
QbMobile generates standardized scores (SD-scores) for attention, impulsivity, activity, and movement patterns using age and sex at birth adjusted norms. These scores provide objective data collected during the 10-minute test session and are automatically included in a standardized report generated immediately upon test completion. This supports evaluation of test validity for ADHD-related symptom measurement.
次要结局
- QbMobile ADHD Symptom Likelihood Score Across Diagnostic Groups(10 minute testing period)
- Comparison of QbMobile SD-Scores Across Testing Environments(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(QbMobile completed at Visit 1 (Day 1) and Visit 2 (Day 2).)