About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Chinese children aged 6 to 12
Trial design
Other
Prospective
Treatments tested in this trial
AHEF
Diagnostic testAssisted assessment system for attention deficit hyperactivity disorder: All participants who pass the screening must undergo the assessment using this assisted system.
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Sensitivity.
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Specificity.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: