A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children (NCT07552909) | Clinical Trial Compass
RecruitingNot Applicable
A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children
China146 participantsStarted 2025-08-24
Plain-language 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.
Who can participate
Age range7 Years – 11 Years
SexALL
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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.
What they're measuring
1
Inattention
Timeframe: The first week after the intervention
2
Hyperactivity-Impulsivity
Timeframe: The first week after the intervention
Trial details
NCT IDNCT07552909
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine