Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
Recruiting · NCT06860763 · Interventional (participants receive a specific treatment) · Lead sponsor: The Third Affiliated Hospital of Beijing University of Chinese Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed.
- Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine - Beijing, Chaoyang District, China