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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Explore the interventional effects of neurofeedback games on school-aged children with mild to moderate ADHD, with the aim of providing evidence-based new methods for intervening in the core symptoms of ADHD in children.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 11
Healthy Volunteers: f
View:
• Children aged 7 years 0 months to 11 years 11 months
• Clinical diagnosis of ADHD made by a child psychiatrist at the attending level or above
• Wechsler Intelligence Scale for Children (WISC) Full Scale IQ (FSIQ) above 85
• 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
Locations
Other Locations
China
Weiping Xia
RECRUITING
Shanghai
Contact Information
Primary
Weiping Xia, PhD
summertree20@163.com
+8613761137709
Backup
Yiting Wu, Master
estherwyt@163.com
+8618201750534
Time Frame
Start Date: 2025-08-24
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 146
Treatments
No_intervention: control group
Control group: Participants will receive standard clinical care, with treatment strategies determined by the clinician based on their clinical experience, professional knowledge, and the specific condition of the school-aged child with ADHD. This includes outpatient guidance and ADHD health education from the doctor. No study-specific interventions will be applied during this period, and participants will be followed up at predetermined time points.
Experimental: Intervention group
For children in the intervention group, the entire training process will be completed at home. Each training session will last for 30 minutes, and a total of 30 sessions will be completed within 2 months of enrollment. All training frequency and duration will be presented in a quantifiable format.
Related Therapeutic Areas
Sponsors
Leads: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine