New ADHD assessment system could sharpen diagnosis in kids

NCT ID NCT07683156

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Recruiting now
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
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Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Jul 06, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study tests a new system called AHEF designed to help doctors diagnose attention-deficit/hyperactivity disorder (ADHD) in children aged 6 to 12. The trial includes children with possible ADHD symptoms as well as healthy children, and measures how accurate and safe the system is. If it works well, it could become a helpful tool for making more reliable ADHD diagnoses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AHEF (Attention-Deficit/Hyperactivity Disorder Auxiliary Evaluation System)
What this could lead to
If successful, this could provide a faster, more reliable tool to help doctors diagnose ADHD in children, reducing misdiagnosis.
What could go wrong
This is an early-stage diagnostic study, so the system may not prove accurate enough for widespread use. It is also tested only in Chinese children, so results may not apply elsewhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 570 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Chinese children aged 6 to 12

Ages

6 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Capital Center For Children's Health, Capital Medical University

    Beijing, Beijing Municipality, 100000, China

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 401122, China

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201100, China

  • Nanjing Women and Children's Healthcare Hospital

    Nanjing, Jiangsu, 210000, China

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518000, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000, China

  • West China Second University Hospital,Sichuan University

    Chengdu, Sichuan, 610000, China

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