Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder (NCT05810636) | Clinical Trial Compass
By InvitationNot Applicable
Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder
Taiwan200 participantsStarted 2022-02-16
Plain-language summary
Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. Clinical diagnosis of this disorder depends of history taking, parent report, and questionnaire. Attention test such as continuous performance test can provide quantitative measurement on attention deficits; however, there is a lack of objective tool to quantify the activity level. This study aims to assess activity level in children with ADHD. We plan to recruit 50 children with ADHD and 50 neurotypical children. The activity level measured by wearable device will be compared between ADHD and neurotypical children. The correlation between behavior rating on questionnaire and quantitative data measured by wearable device will be analyzed.
Who can participate
Age range
6 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
ADHD group:
Inclusion criteria:
* DSM-5 Attention-deficit hyperactivity disorder
* 7\~18 years old
* Willing to carry smartwatch and smartphone most of the time during one-month study period
Exclusion criteria:
* Comorbid with major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder)
* Unable to use smartwatch and smartphone
Neurotypical group:
Inclusion criteria:
* 7\~18 years old without a diagnosis of Attention-deficit hyperactivity disorder
* Willing to carry smartwatch and smartphone most of the time during one-month study period
Exclusion criteria:
* Have a diagnosis of major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder)
* Unable to use smartwatch and smartphone
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is measuring 'acceleration' in children with ADHD — can you explain what that means in practice, and whether it involves wearable devices or movement tracking that my child would need to wear during daily life?
2Since this trial is enrolling by invitation only, can you tell me whether my child might be eligible to be invited, and what criteria are typically used to select participants?
3This study is listed as Phase NA, which suggests it may be observational rather than a treatment trial — does that mean my child wouldn't be receiving any new medication or therapy as part of participating?
4If this study is mainly about assessing or measuring hyperactivity rather than treating it, how would participating benefit my child directly, or is the primary purpose to contribute to research that helps future patients?
5While we consider whether this study is worth pursuing, what standard ADHD treatments are currently available that we should be discussing at the same time, so my child's care isn't delayed?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.