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Tratamiento de acupuntura para el TDAH: minería de datos de acupuntos a través de la revisión de la literatura, la efectividad clínica, la seguridad y las entrevistas cualitativas para explorar los resultados y las ideas del tratamiento (ACU-ADHD). (ACU-ADHD)

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

Estudio clínico sobre el tratamiento de acupuntura para el trastorno por déficit de atención hiperactividad.

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.

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Xue Bai, Ph.D.
  • Número de teléfono: +8618810212203
  • Correo electrónico: baixue8912@163.com

Ubicaciones de estudio

    • Chaoyang District
      • Beijing, Chaoyang District, Porcelana, 100036
        • Reclutamiento
        • Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 años a 12 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
SNAP-IV
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Conners 3-P
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de octubre de 2024

Finalización primaria (Estimado)

15 de diciembre de 2026

Finalización del estudio (Estimado)

31 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de marzo de 2025

Primero enviado que cumplió con los criterios de control de calidad

5 de marzo de 2025

Publicado por primera vez (Actual)

6 de marzo de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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