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.
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.
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.
Parallel
Chinese herbal medicine
DrugThe general treatment strategy will follow principles of clearing excess and replenishing deficiency, regulating the internal organs, and balancing yin and yang. Based on the patient's specific syndrome in TCM.
Acupuncture
DeviceThe acupuncture needles used will be 0.25 mm in diameter and 25 mm in length, inserted quickly with even supplementation and reduction techniques.
SNAP-IV
Swanson, Nolan, and Pelham Rating Scale. * Items: 18 (9 inattention + 9 hyperactivity/impulsivity). * Response Options: 0 = Not at all, 1 = Just a little, 2 = Quite a bit, 3 = Very much. * Interpretation: Higher scores mean more severe ADHD symptoms (worse outcome).
Conners 3-P
Conners 3rd Edition-Parent Rating Scale. * Items: 48 * Response Options: 0 (Not true at all) to 3 (Very much true) * Interpretation: Higher scores reflect more severe ADHD-related problems (worse outcome)
BRIEF-2
Behavior Rating Inventory of Executive Function, Second Edition. * Items: 63 * Response Options: 0 (Never) to 2 (Always) * Scoring: Raw scores are converted to T-scores; T-scores over 65 indicate a clinically elevated level * Interpretation: Higher T-scores denote greater executive function difficulties (worse outcome)
PedsQL 4.0 generic score
Pediatric Quality of Life Inventory. * Items: 23 * Response Options: 0 (Never), 2 (Sometimes), 4 (Always). Score Range: Original responses are transformed into a 0-100 scale * Interpretation: Higher scores indicate better quality of life (better outcome)
PSQI
Pittsburgh Sleep Quality Index. * Items: 18 total * Response Options: For 14 of those items, 0 (Never), 1 (\<1 time/week), 2 (2 times/week), 3 (≥3 times/week) * Score Range: 0-21 for the global score * Interpretation: Higher scores indicate poorer sleep quality (worse outcome)
Click on the lead sponsor to view all of their trials.
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Lead sponsor
Mahidol University
Collaborator
