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A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children

Randomized Controlled Study on Home-Based Digital Therapy Intervention for School-Aged Children with Attention Deficit Hyperactivity Disorder Based on Brain-Controlled Games

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112312
Enrollment
Unknown
Registered
2025-11-12
Start date
2025-08-24
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention deficit hyperactivity disorder

Interventions

control group:Accept routine clinical interventions, health education from outpatient doctors, family support, interactive guidance, etc. After completing the evaluation at 8 weeks, receive the same i
Intervention group:Home-Based Brain-Controlled Game Digital Therapy

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 7 years 0 months to 11 years 11 months, diagnosed with ADHD by a physician at or above the level of attending child psychiatrist, meeting the diagnostic criteria for ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). These children must have a Wechsler Intelligence Scale for Children (WISC) Full Scale IQ (FSIQ) above 85 and be outpatient children who have been diagnosed with ADHD but have not received any intervention (newly diagnosed within the last month or not having taken medication for at least 4 weeks). Informed consent must be obtained from the patient/guardian and from participants aged 8 years and older.

Exclusion criteria

Exclusion criteria: 1. Auditory or visual illness or disorder; 2. Inability to use software (e.g., color blindness, impaired hand function, or disability); 3. Comorbid oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, tic disorders, or other neurodevelopmental disorders; 4. Other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders; 5. Attention deficit disorder caused by organic neurological diseases or other organic diseases; 6. Previous regular ADHD medication use as prescribed by a doctor, but without efficacy; 7. Past or present gaming addiction; 8. Previous neurofeedback-like "brain control game" interventions; 9. Previous physical therapy such as magnetic stimulation.

Design outcomes

Primary

MeasureTime frame
Inattention / Hyperactivity-Impulsivity;

Secondary

MeasureTime frame
executive function;

Countries

China

Contacts

Public ContactXia Weiping

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

summertree20@163.com+86 21 2507 6686

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026