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Recruiting NCT07552909

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

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Sex: All
Ages: 7 Years – 11 Years
Healthy volunteers: No
Phase: NA
Enrollment: 146
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Location: Weiping Xia Shanghai Shanghai Municipality

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 Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07552909). StuddyBuddy aggregates publicly available trial information.