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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-12
SponsorChongqing Jinsaixing Medical Technology Co., Ltd

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • AHEF

    Diagnostic test

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Sensitivity.

Time frame
Day 1
2

Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Specificity.

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: