Attention-DeficitNCT07683156
Diagnostic Accuracy and Safety of the Attention-Deficit/Hyperactivity Disorder Auxiliary Evaluation System (AHEF) in Chinese Children Aged 6 to 12
An observational study of Attention-Deficit and Hyperactivity Disorder, run by Chongqing Jinsaixing Medical Technology Co., Ltd at 8 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit, Hyperactivity Disorder
- What is being tested?
- AHEF
- How many people
- 570 participants
- Where
- 8 sitesChina
- Study dates
- 31 Jul 2026to 4 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Chinese children aged 6 to 12
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites
Capital Center For Children's Health, Capital Medical University
Beijing, Beijing Municipality, 100000
The First Hospital of Jilin University
Changchun, Jilin, 130000
West China Second University Hospital,Sichuan University
Chengdu, Sichuan, 610000
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 401122
Shirong Cai, 023-68370035/023-63664659, chcmull@163.com
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Nanjing Women and Children's Healthcare Hospital
Nanjing, Jiangsu, 210000
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201100
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518000
About this study
Official title: 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.
- Conditions
- Attention-Deficit, Hyperactivity Disorder
- Being tested
- AHEF
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHEFDiagnostic test
Assisted assessment system for attention deficit hyperactivity disorder: All participants who pass the screening must undergo the assessment using this assisted system.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Sensitivity.
Measured: Day 1
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Specificity.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion4 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-DeficitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Jinsaixing Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683156
- Sponsor's protocol ID
- JSX-1003-PCT01
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07683156
- Acronym / sponsor ID
- JSX-1003-PCT01
- Conditions
- Attention-Deficit, Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Chongqing Jinsaixing Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 4 Apr 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Chinese children aged 6 to 12
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHEFAssisted assessment system for attention deficit hyperactivity disorder: All participants who pass the screening must undergo the assessment using this assisted system. | Diagnostic test | – |
Primary outcome
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Sensitivity.
Time frame: Day 1
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Specificity.
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-Deficit and Hyperactivity Disorder, run by Chongqing Jinsaixing Medical Technology Co., Ltd at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Wang (+86 13596169192, wangmin@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the diagnostic efficacy of the Attention Deficit Hyperactivity Disorder Auxiliary Evaluation System (AHEF) including Sensitivity. (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.