Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Tre… (NCT06860763) | Clinical Trial Compass
RecruitingNot Applicable
Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
China120 participantsStarted 2024-10-15
Plain-language summary
This study aims to evaluate the efficacy of acupuncture as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6-12 years. Using a mixed-methods approach, the research will triangulate data from acupoint data mining, treatment outcomes assessment, and patient perspectives to provide a comprehensive analysis of acupuncture's potential therapeutic benefits for ADHD.
This prospective cohort study will recruit children diagnosed with ADHD, assigning them to receive either acupuncture combined with traditional Chinese herbal treatment or herbal treatment alone. Quantitative assessments using the the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL™ 4.0 Generic Core Scales, PSQI and CGI that will be complemented by qualitative interviews to capture nuanced patient experiences and treatment outcomes.
The study will span 12 months, commencing on March 1st, 2025 with an expected completion by February 28th, 2026. By integrating quantitative assessments with qualitative insights, it aims to provide comprehensive evidence on acupuncture's role in ADHD management. Findings may inform clinical guidelines and enhance patient-centered care approaches.
Who can participate
Age range
6 Years – 12 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.
Inclusion Criteria:
Patients will be considered for enrolment if they meet the criteria of:
* A confirmed diagnosis of ADHD based on the DSM-5 criteria for ADHD (Western medical diagnosis) and in accordance with the ADHD Chinese Medicine Clinical Trial Design and Evaluation Technical Guidelines.
* Aged between 6 and 12 years.
* No use of any other pharmacological treatments (both Western and traditional Chinese medicine) within the two weeks prior to the start of the study.
* An IQ score of greater than 80, as determined by the Raven's Progressive Matrices test.
* The participant has not participated in any other clinical trials.
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
* Do not meet the inclusion criteria
* Have comorbid psychiatric disorders, severe medical or psychiatric conditions that may interfere with the study (e.g., epilepsy, severe anxiety), pervasive developmental disorders, intellectual disability, or a history of suicidal or self-harming behavior
* Have participated in any other drug clinical trials within the past 3 months.
* Have severe comorbid conditions such as cardiovascular, hepatic, renal, or hematologic diseases.
* Have any other conditions that the researchers believe may interfere with the assessment of treatment efficacy or safety.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
SNAP-IV
Timeframe: From enrollment to the end of treatment at 8 weeks
Trial details
NCT IDNCT06860763
SponsorThe Third Affiliated Hospital of Beijing University of Chinese Medicine