Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Interventions
treatment group:Digital therapy product FocusPro1
control group:Common pattern recognition game software
Sponsors
BEIJING ANDING HOSPITAL CAPITAL MEDICAL UNIVERSITY
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.6 years old = age = 12 years old, no gender limit 2. Patients who meet the diagnostic criteria for ADHD in the American Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), attention deficit type or mixed type 3.SNAP-IV score =28 4.TOVA-ACS=-1.8; 5.CGI=4; 6. Do not use ADHD treatment drugs such as methylphenidate, atomoxetine, traditional Chinese medicine (such as Duodongning capsules, children's intelligence syrup, Jingling oral liquid, other traditional Chinese medicine prescriptions) or have stopped taking them 2 weeks before screening 7. Patients and/or their guardians agree to participate in this study and voluntarily sign an informed consent form. Subjects aged 8 years and above should also sign a children's informed consent form.
Exclusion criteria
Exclusion criteria: 1. Suffering from neurodevelopmental disorders such as cerebral palsy, epilepsy, adrenoleukodystrophy, etc. 2. Suffering from serious mental illnesses such as tic disorder, autism spectrum disorder, mental retardation, schizophrenia, bipolar disorder, depressive disorder, and special learning skill development disorder 3. Hearing impairment causes symptoms similar to those with attention-deficit-hyperactivity disorder in children 4. At any stage of the research, you need to take other antipsychotic, antidepressant and other central nervous system drugs (including Chinese and Western medicines, health products) 5. Patients who are still ineffective after systemic treatment with two different types of ADHD drugs 6. People who are color blind and unable to use the software normally 7. Past or current game addict 8. Those who must receive systemic psychotherapy, family therapy or transcranial magnetic therapy at the same time during the trial 9. Received non-drug treatments such as systemic behavioral therapy or physical therapy within one month before enrollment 10. Movement status that hinders intervention reported by family members or observed by researchers (such as physical deformity or dysfunction of the hand/arm, use of prostheses, etc.) 11. Those who have had suicidal thoughts or who are judged by researchers to have serious suicidal impulses 12. Those who are participating in other clinical trials within 1 month and have not yet participated in the group 13. Those who the researcher believes are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in Attention Change Index (Tova-ACS) compared to baseline at 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in attention change index (TOVA-ACS) at week 4;Changes in SNAP-IV scale parent version scores from baseline;Clinical efficacy summary scale CGI score; | — |
Countries
China
Contacts
Public ContactZheng Yi
Beijing Anding Hospital Affiliated to Capital Medical University
Outcome results
None listed