Attention Deficit Hyperactivity Disorder
Conditions
Interventions
Intervention group:Digital therapeutics (DTx).
Participants use a music rhythm serious game called "Start Beat," which is provided through a mobile application (WeChat Mini Program). Participants are
Control group:Routine treatment.
During the 4 week study period, participants only continue their ADHD medication treatment that has been stable and routine clinical follow up management, and do not r
Sponsors
Zhangzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6–17 years, no restriction on sex; 2. Diagnosed by a professional pediatric or psychiatric physician and meeting DSM-5 diagnostic criteria for ADHD (any subtype); 3. Currently receiving ADHD pharmacological treatment for =8 weeks, with a stable medication regimen for the past 4 weeks, and symptoms still having room for improvement; 4. IQ >= 70 on intellectual level assessment; 5. No severe visual, hearing, or motor impairments, and able to understand and operate the electronic devices required for the trial; 6. No participation in other psychological or pharmacological clinical studies and other digital product treatments within the past 1 month; 7. The legal guardian signs the informed consent form, and the family can cooperate with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Comorbid with other severe mental disorders (such as autism spectrum disorder, schizophrenia, etc.) or a definite history of neurological diseases (such as epilepsy); 2. Having severe anxiety, depression, or other mood disorders at baseline that require priority management; 3. Severe visual impairment or color blindness; 4. Uncorrected hearing loss or severe auditory processing disorder; 5. Severe intellectual disability (IQ < 70); 6. The child participant or the parent is unable to comply with the study plan; 7. Other situations deemed unsuitable for participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD Rating Scale V; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weiss Functional Impairment Rating Scale;Swanson, Nolan, and Pelham Questionnaire IV;Conners Parent Rating Scale;Strengths and Difficulties;Objective improvement in attention; | — |
Countries
China
Contacts
Public ContactRuntao Fang
Zhangzhou Municipal Hospital
Outcome results
None listed