Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes. (ACU-ADHD)

December 13, 2025 updated by: Tananan Sangwanit, The Third Affiliated Hospital of Beijing University of Chinese Medicine

Clinical Study on Acupuncture Treatment for Attention Deficit Hyperactivity Disorder.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Attention Deficit Hyperactivity Disorder (ADHD) remains a prevalent neurodevelopmental disorder affecting children worldwide, often characterized by persistent patterns of inattention, hyperactivity, and impulsivity that significantly impair daily functioning. While conventional treatments such as stimulant medications and behavioral therapies are commonly prescribed, interest in complementary and alternative approaches, including acupuncture, has grown. This study proposes a rigorous examination of acupuncture's potential efficacy as a treatment modality for ADHD, employing a mixed-methods approach to triangulate acupoint data mining, treatment outcomes assessment, and patient perspectives.

The primary objective is to evaluate the therapeutic effects of acupuncture in children aged 6-12 years diagnosed with ADHD. The research design involves a prospective cohort study wherein participants will be allocated to receive either acupuncture combined with traditional Chinese herbal treatment or herbal treatment alone. Quantitative assessment of ADHD symptom and related impairment administered at baseline, post-treatment, and follow-up intervals. Additionally, qualitative interviews with participants, their caregivers and clinicians will explore subjective experiences, treatment satisfaction, and perceived changes in ADHD symptoms.

This prospective cohort study will recruit 6-12 year-old children diagnosed with ADHD from pediatrics department of the third affiliated hospital of Beijing University of Chinese Medicine. Participants will be randomly assigned to two groups: an experimental group receiving acupuncture alongside traditional Chinese herbal treatment, and a control group receiving only the herbal treatment. The study will adhere to ethical guidelines, ensuring informed consent from parents and assent from children.

The research content includes three parts, as follows Phase I: Acupoint data mining for core acupoints Acupoint data mining will guide personalized treatment protocols, selecting points historically used for ADHD and supported by current research.

Phase II: Clinical Trial Intervention Quantitative assessment will involve administering the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL™ 4.0 Generic Core Scales, PSQI and CGI at baseline, post-treatment, and follow-up intervals to measure changes in ADHD symptomatology, executive function, quality of life, and sleep quality.

Phase III: Qualitative Interview Qualitative methods will complement quantitative findings, capturing subjective experiences through semi-structured interviews with children, parents, and clinicians. This approach aims to provide a holistic understanding of treatment efficacy, patient satisfaction, and perceived improvements in ADHD symptoms, executive function, quality of life, and sleep patterns.

Statistical analyses will compare SNAP-IV, Conners 3-P, BRIEF-2, PSQI and PedsQL™ 4.0 Generic Core Scales scores between groups, supplemented by thematic analysis of qualitative data to explore treatment satisfaction and symptom changes.

Statistical analyses, including paired t-tests, ANOVA, and thematic analysis, will be employed to compare outcomes between treatment groups and explore correlations between acupuncture treatment, symptom alleviation, and overall well-being measures.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chaoyang District
      • Beijing, Chaoyang District, China, 100036
        • Recruiting
        • Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Acupuncture will be based on the first phase of data analysis, which identifies acupuncture point selection patterns for ADHD in school-age children.
Device: Acupuncture
The acupuncture needles used will be 0.25 mm in diameter and 25 mm in length, inserted quickly with even supplementation and reduction techniques.
Drug: Chinese herbal medicine
The 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.
Active Comparator: Chinese Herbal Medicine
Chinese herbal decoction based on the 2019 edition of the "Clinical Diagnosis and Treatment Guidelines for Pediatric ADHD" by the Chinese Society of Traditional Chinese Medicine.
Drug: Chinese herbal medicine
The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SNAP-IV
Time Frame: From enrollment to the end of treatment at 8 weeks

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).
From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BRIEF-2
Time Frame: From enrollment to the end of treatment at 8 weeks

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)
From enrollment to the end of treatment at 8 weeks
PedsQL 4.0 generic score
Time Frame: From enrollment to the end of treatment at 8 weeks

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)
From enrollment to the end of treatment at 8 weeks
PSQI
Time Frame: From enrollment to the end of treatment at 8 weeks

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)
From enrollment to the end of treatment at 8 weeks
VADRS
Time Frame: From enrollment to the end of treatment at 8 weeks

Vanderbilt ADHD Diagnostic Rating Scale.

  • Items: 55 (ADHD core symptoms + comorbid items)
  • Response Options: 0 (Never) to 3 (Very often)
  • Interpretation: Higher scores signify more severe ADHD symptoms and comorbidity (worse outcome)
From enrollment to the end of treatment at 8 weeks
CGI
Time Frame: From enrollment to the end of treatment at 8 weeks

Clinical Global Impression.

CGI-Severity (CGI-S):

  • Scale: 7 points, typically from 1 (Normal, not ill) to 7 (Among the most extremely ill)
  • Interpretation: Higher scores indicate more severe illness (worse outcome).

CGI-Improvement (CGI-I):

  • Scale: 7 points, typically from 1 (Very much improved) to 7 (Very much worse)
  • Interpretation: Lower scores indicate greater improvement, while higher scores represent worsening.
From enrollment to the end of treatment at 8 weeks
Conners 3-P
Time Frame: From enrollment to the end of treatment at 8 weeks

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)
From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Affiliated Hospital of Beijing University of Chinese Medicine

Collaborators

Mahidol University

Investigators

  • Study Director: Xia Cui, Ph.D.,Prof., Third Hospital of Beijing University of Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

March 1, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BZYSY-2024YJSKTPJ-99

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing IPD is not permitted due to privacy concerns, ethical and legal restrictions, and institutional policies. Protecting minors' confidentiality and adhering to data security standards are priorities.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Children

Clinical Trials on Acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe