Combining qualitative and quantitative research methods: considering the possibilities for enhancing the study of chronic diseases.
A L Casebeer, M J Verhoef
https://pubmed.ncbi.nlm.nih.gov/9375260Actively Recruiting
Phase Not Applicable
Age: 6Years - 12Years
All Genders
ID06860763
Clinical Study on Acupuncture Treatment for Attention Deficit Hyperactivity Disorder
Led by The Third Affiliated Hospital of Beijing University of Chinese Medicine · Updated on 2025-12-19
76
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
Sponsors
T
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Lead Sponsor
M
Mahidol University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the potential benefits of acupuncture as a treatment for children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). It compares acupuncture combined with traditional Chinese herbal treatment to herbal treatment alone, using a mixed-methods approach that includes data mining, treatment outcome assessments, and patient perspectives. The study seeks to provide a detailed understanding of acupuncture's role in managing ADHD symptoms, executive function, quality of life, and sleep quality. Participants will be assigned to either an experimental group receiving acupuncture alongside herbal medicine or a control group receiving only the herbal treatment based on Chinese Medicine clinical guidelines. Acupuncture treatments involve specific needles and techniques informed by prior data analysis of effective acupoints for ADHD. Herbal treatments follow established clinical guidelines for pediatric ADHD. The study includes three phases: acupoint data mining, clinical intervention with repeated assessments, and qualitative interviews with children, caregivers, and clinicians. During the 12-month study, children will undergo quantitative assessments such as the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL 4.0, PSQI, and CGI at baseline, post-treatment, and follow-up points to measure ADHD symptoms and related impacts. Qualitative interviews will explore treatment experiences and satisfaction. Researchers will analyze changes in symptoms, executive function, quality of life, and sleep, combining statistical methods with thematic analysis. The study starts in October 2024 and is expected to complete by May 2026.
CONDITIONS
Brief Title
Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
Who Can Participate
Age: 6Years - 12Years
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed ADHD diagnosis based on DSM-5 criteria and Chinese Medicine clinical guidelines
- Age between 6 and 12 years
- No use of other pharmacological treatments within 2 weeks before the study
- IQ score greater than 80 by Raven's Progressive Matrices test
- No participation in other clinical trials
You will not qualify if you...
- Not meeting inclusion criteria
- Comorbid psychiatric disorders or severe medical conditions affecting the study (e.g., epilepsy, severe anxiety)
- Pervasive developmental disorders or intellectual disability
- History of suicidal or self-harming behavior
- Participation in other drug clinical trials within past 3 months
- Severe cardiovascular, hepatic, renal, or hematologic diseases
- Any other condition that may interfere with treatment assessment or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 8 weeks
Participants receive either acupuncture combined with traditional Chinese herbal treatment or herbal treatment alone to evaluate effects on ADHD symptoms.
Weekly visits for up to 8 weeks
Follow-up
Duration - Post-treatment follow-up period
Participants undergo assessments to evaluate changes in ADHD symptoms, executive function, quality of life, and sleep quality after treatment completion.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine
Beijing, Chaoyang District, China, 100036
Actively Recruiting
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Research Team
T
Tananan Sangwanit, Ph.D.student
X
Xue Bai, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Can acupuncture improve objective sleep indices in patients with primary insomnia? A systematic review and meta-analysis.
Fei-Yi Zhao, Qiang-Qiang Fu, Gerard A Kennedy...
https://pubmed.ncbi.nlm.nih.gov/33610071Randomized-controlled study of treating attention deficit hyperactivity disorder of preschool children with combined electro-acupuncture and behavior therapy.
Shasha Li, Bo Yu, Zhenlang Lin...
https://pubmed.ncbi.nlm.nih.gov/21056840The efficacy of acupuncture for attention deficit hyperactivity disorder (ADHD): An overview of systematic reviews and meta-analyses.
Lulu Zhang, Chuyu Huang, Xinying Chen...
https://pubmed.ncbi.nlm.nih.gov/37562658Acupuncture for Treating Attention Deficit Hyperactivity Disorder in Children: A Systematic Review and Meta-Analysis.
Lin Ang, Jung Tae Kim, Kibong Kim...
https://pubmed.ncbi.nlm.nih.gov/36837594Effect of Liuwei Dihuang decoction, a traditional Chinese medicinal prescription, on the neuroendocrine immunomodulation network.
Wenxia Zhou, Xiaorui Cheng, Yongxiang Zhang
https://pubmed.ncbi.nlm.nih.gov/26896567Wolraich ML, Hagan JF, Allan C, et al; Subcommittee on Children and Adolescents with Attention-Deficit/Hyperactive Disorder. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019;144(4):e20192528.
https://pubmed.ncbi.nlm.nih.gov/32111626Prevalence, Patterns, and Predictors of Sleep Problems and Daytime Sleepiness in Young Adolescents With ADHD.
Joshua M Langberg, Stephen J Molitor, Lauren E Oddo...
https://pubmed.ncbi.nlm.nih.gov/28162039Objectively measured sleep continuity in children and adolescents with ADHD: A systematic review and meta-analysis.
Xiao Liang, Hui Qiu, Shirley Xin Li
https://pubmed.ncbi.nlm.nih.gov/37657199The Impact of Childhood Attention-Deficit/Hyperactivity Disorder (ADHD) on Children's Health-Related Quality of Life: A Systematic Review and Meta-Analysis.
Sithara Wanni Arachchige Dona, Nalini Badloe, Emma Sciberras...
https://pubmed.ncbi.nlm.nih.gov/36800919