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

NCT06860763 | Recruiting DMC

• 1 other identifier: BZYSY-2024YJSKTPJ-99
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acupuncture; ADHD - Attention Deficit Disorder With Hyperactivity; Children; Interview; Executive Functioning; Quality of Life (QOL)

Keywords

Acupuncture; ADHD; Executive functioning; Interview; TCM; PedsQL

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (6)

• Conners 3-P

  From enrollment to the end of treatment at 8 weeks

• BRIEF-2

  From enrollment to the end of treatment at 8 weeks

• PedsQL 4.0 generic score

  From enrollment to the end of treatment at 8 weeks

• PSQI

  From enrollment to the end of treatment at 8 weeks

• VADRS

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Chinese Herbal Medicine

ACTIVE COMPARATOR

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

Acupuncture

EXPERIMENTAL

Acupuncture will be based on the first phase of data analysis, which identifies acupuncture point selection patterns for ADHD in school-age children.

Drug: Chinese herbal medicine; Device: Acupuncture

Interventions

Acupuncture DEVICE

The acupuncture needles used will be 0.25 mm in diameter and 25 mm in length, inserted quickly with even supplementation and reduction techniques.

Acupuncture

Chinese herbal medicine DRUG

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.

Acupuncture; Chinese Herbal Medicine

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following 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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Beijing University of Chinese Medicine: lead
• Mahidol University: collaborator

Study Sites (1)

Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine

Beijing, Chaoyang District, 100036, China

RECRUITING

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Xia Cui, Ph.D.,Prof.

  Third Hospital of Beijing University of Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Tananan Sangwanit, Ph.D.student

CONTACT

+8615201052193; tananan.sangwanit@gmail.com

Xue Bai, Ph.D.

CONTACT

+8618810212203; baixue8912@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (PI)

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: October 15, 2024
• Primary Completion: April 15, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)