A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children
Recruiting · NCT07552909 · Interventional (participants receive a specific treatment) · Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
Home-based digital therapy with brain-controlled games
What this trial is about
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.
Who can take part
Age range
7 Years to 11 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Auditory or visual illness or disorder
- Inability to use software (e.g., color blindness, impaired hand function, or disability)
- Comorbid oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, tic disorders, or other neurodevelopmental disorders
- Other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders
- Attention deficit disorder caused by organic neurological diseases or other organic diseases
- Previous regular ADHD medication use as prescribed by a doctor, but without efficacy
- Past or present gaming addiction
- Previous neurofeedback-like "brain control game" interventions
- Previous physical therapy such as magnetic stimulation.
Where it is running
1 location listed.
- Weiping Xia - Shanghai, Shanghai Municipality, China