Clinical trial NCT06860763: Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
Official title: Clinical Study on Acupuncture Treatment for Attention Deficit Hyperactivity Disorder.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acupuncture
ADHD - Attention Deficit Disorder With Hyperactivity
Children
Interview
Executive Functioning
Quality of Life (QOL)
Keywords: Acupuncture
ADHD
Executive functioning
Interview
TCM
PedsQL
Lead sponsor: The Third Affiliated Hospital of Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: National Institute for Child and Family Development, Mahidol University
name: Mahidol University
First posted: 2025-03-06
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SNAP-IV
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Conners 3-P
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: BRIEF-2
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: PedsQL 4.0 generic score
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: PSQI
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: VADRS
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: CGI
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine
state: Chaoyang District
Study officials:
affiliation: Third Hospital of Beijing University of Chinese Medicine
name: Xia Cui, Ph.D.,Prof.
role: STUDY_DIRECTOR
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