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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperactivity Disorder; Attention-Deficit
• Intervention / Treatment: Diagnostic test: AHEF

• Study Type: Observational
• Enrollment (Estimated): 570

Contacts and Locations

• Study Contact: Name: Min Wang; Phone Number: +86 13596169192; Email: wangmin@genscigroup.com

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 401122
      • Children's Hospital of Chongqing Medical University
      • Contact: Shirong Cai; Phone Number: 023-68370035/023-63664659; Email: chcmull@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Chinese children aged 6 to 12

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Sensitivity.	Day 1
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Specificity.	Day 1

Collaborators and Investigators

• Sponsor: Chongqing Jinsaixing Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): April 4, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: JSX-1003-PCT01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No