Diagnostic Accuracy and Safety of the Attention-Deficit/Hyperactivity Disorder Auxiliary Evaluation System (AHEF) in Chinese Children Aged 6 to 12

Официальное название

A Multicenter Prospective Clinical Study: Evaluating the Diagnostic Efficacy and Safety of the Attention-Deficit/Hyperactivity Disorder Auxiliary Evaluation System (AHEF) in Chinese Children Aged 6 to 12

Обзор

This clinical trial aims to evaluate the diagnostic efficacy and safety of the Attention Deficit Hyperactivity Disorder Assessment System (AHEF) in children aged 6 to 12 in China, while ensuring the safety of the subjects and maintaining the scientific integrity of the clinical trial.

Вмешательства

• Диагностический тест AHEF
  Assisted assessment system for attention deficit hyperactivity disorder: All participants who pass the screening must undergo the assessment using this assisted system.

Первичные конечные точки

• Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Sensitivity. [Срок оценки: Day 1]
• Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Specificity. [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Age range: 6-12 years old, gender not restricted;
• For children presenting for an initial ADHD diagnostic visit: presenting with common symptoms of ADHD such as inattention, hyperactivity, impulsivity, learning difficulties, behavioral problems, etc., and requiring a comprehensive assessment to confirm the diagnosis; Normal children: showing no obvious abnormal manifestations in family and school life, such as parents or teachers' initial assessment indicating basic health and normal neurodevelopmental behavioral performance, with no relevant medical history;
• Normal intelligence (Wechsler Intelligence Scale for Children IQ ≥ 85);
• The patient and/or their guardian have agreed to participate in the study and have signed the informed consent form; for participants aged 8 and above, a pediatric informed consent form must also be signed.

Критерии исключения

• Suffering from mental disorders or other neurodevelopmental disorders (such as autism spectrum disorder, schizophrenia, bipolar disorder, depressive disorder, tic disorder, reading disorder, anxiety disorders or stress-related disorders that still meet the diagnostic criteria within the last 6 months), neurological diseases such as epilepsy, and brain organic diseases, etc.;
• Acute stage of respiratory, digestive, circulatory, urinary, immune, endocrine system diseases or acute episodes of chronic diseases (such as common acute symptoms like fever, breathing difficulties, diarrhea, etc.) and those judged by the investigator to potentially affect the research results;
• Hearing impairment with corrected hearing not within the normal range, visual impairment with corrected vision not within the normal range, visual impairments such as color blindness, and other visual or hearing problems affecting software users;
• Those previously diagnosed with ADHD or suspected ADHD;
• Those who have received, are receiving, or plan to receive any psychological treatment for ADHD or non-drug treatment for the nervous system, or other cognitive, psychological-related behavioral intervention treatments in the past 6 months;
• Those who have received neurological drug treatment (especially ADHD treatment drugs) and are still within 5 half-lives after the last medication at the time of enrollment; those who are currently receiving or plan to receive any ADHD or neurological drug treatment during the trial;
• Those who have had gaming addiction in the past;
• Motor conditions (e.g., hand dysfunction) reported by family members or observed by the investigator that would interfere with the trial procedures.
• Those who have had suicidal thoughts or the investigator judges that they have suicidal impulses, non-suicidal self-harm impulses;
• Those who are participating in other clinical trials or have not completed other trials within 1 month;
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 8 центров

• Capital Center For Children's Health, Capital Medical University — Пекин
• Children's Hospital of Chongqing Medical University — Чунцин
• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• Shenzhen Children's Hospital — Шэньчжэнь
• Nanjing Women and Children's Healthcare Hospital — Нанкин
• The First Hospital of Jilin University — Changchun
• Children's Hospital of Fudan University — Шанхай
• West China Second University Hospital,Sichuan University — Чэнду

Идентификаторы

NCT: NCT07683156 · JSX-1003-PCT01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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