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Tratamento da acupuntura para TDAH: mineração de dados de pontos de acupuntura por meio de revisão da literatura, eficácia clínica, segurança e entrevistas qualitativas para explorar resultados e insights de tratamento (ACU-ADHD). (ACU-ADHD)

3 de novembro de 2026 atualizado por: Tananan Sangwanit, The Third Affiliated Hospital of Beijing University of Chinese Medicine

Estudo clínico sobre tratamento de acupuntura para transtorno do déficit de atenção hiperatividade.

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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

120

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

6 anos a 12 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.

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.

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.

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.

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
SNAP-IV
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Conners 3-P
Prazo: 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
BRIEF-2
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Colaboradores

Investigadores

  • Diretor de estudo: Xia Cui, Ph.D.,Prof., Third Hospital of Beijing University of Chinese Medicine

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de outubro de 2024

Conclusão Primária (Estimado)

15 de dezembro de 2026

Conclusão do estudo (Estimado)

31 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de março de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de março de 2025

Primeira postagem (Real)

6 de março de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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