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

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.

1. Research Title

   A Randomized Controlled Study on the Efficacy of Home-Based Digital Therapy with Brain-Controlled Games for School-Aged Children with Attention Deficit Hyperactivity Disorder.

2. Research Objective

   To explore the efficacy of brain-controlled games as an intervention for school-aged children with mild to moderate ADHD, with the aim of providing a new evidence-based method to intervene in the core symptoms of ADHD.

3. Study Design

   Randomized Controlled Study.

4. Total Cases

5. Case Selection

   Inclusion Criteria: Children aged 7 years, 0 months to 11 years, 11 months who are diagnosed by a physician with at least the rank of attending physician in pediatric psychiatry as meeting the diagnostic criteria for ADHD according to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), have a full-scale Wechsler IQ higher than 85, and are outpatient children with ADHD who have not received any intervention (newly diagnosed within the last month or have not taken medication for at least 4 weeks). Informed consent will be obtained from the patient/guardian and from participants aged 8 years and older.

6. Exclusion Criteria

   Exclusion criteria include:

   1. Auditory or visual diseases or disorders.
   2. Inability to use the software, such as color blindness, or hand function defects or disabilities.
   3. Comorbidities with other neurodevelopmental disorders such as oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, Tourette's syndrome, etc.
   4. Patients with other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders.
   5. Attention deficit disorder caused by organic diseases of the nervous system or other organic diseases.
   6. Previous history of ineffective regular ADHD medication as prescribed by a doctor.
   7. Past or present game addiction.
   8. Previous similar brain-controlled game interventions like Neurotest.
   9. Previous physical therapy such as magnetic stimulation.

7. Treatment Protocol

   Home-based digital therapy with ADHD brain-controlled games.

8. Efficacy Assessment

   Primary Outcome Measure: ADHD SNAP-IV subscale scores (Inattention/Hyperactivity-Impulsivity).

   Secondary Outcome Measure: Executive Function (BRIEF) questionnaire scores.

9. Statistical Methods

The differences in evaluation results between the intervention group and the control group will be analyzed using a repeated measures analysis of variance from a general linear model. Missing data will be handled using the Last Observation Carried Forward (LOCF) method. The study will control for inter-group bias through measures such as random assignment, consistent training of evaluators, and blind evaluation where the evaluators are unaware of the subjects' treatment status.

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.