Clinical Study on Acupuncture Treatment for Attention Deficit Hyperactivity Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- SNAP-IV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Chinese herbal medicine (Drug)
Acupuncture
Acupuncture will be based on the first phase of data analysis, which identifies acupuncture point selection patterns for ADHD in school-age children.
干预措施: Chinese herbal medicine (Drug)
Acupuncture
Acupuncture will be based on the first phase of data analysis, which identifies acupuncture point selection patterns for ADHD in school-age children.
干预措施: Acupuncture (Device)
结局指标
主要结局
SNAP-IV
时间窗: 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).
次要结局
- VADRS(From enrollment to the end of treatment at 8 weeks)
- 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)
- CGI(From enrollment to the end of treatment at 8 weeks)
研究者
Tananan Sangwanit
Principal Investigator (PI)
The Third Affiliated Hospital of Beijing University of Chinese Medicine