A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD

Prior treatment

• Serious trauma or surgery performed within 4 weeks before the screening date
• Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date
• Change in the dosage or regimen of medications that may significantly affect cognitive function within 4 weeks prior to the baseline visit
• Change in participation in treatment/education/rehabilitation programs that may significantly affect cognitive function within 4 weeks prior to the baseline visit
• Participation in a clinical trial of, or prior experience using, cognitive improvement or daily living improvement software within 12 weeks prior to the baseline visit

Other illness

• Severe acute/chronic medical or mental illness
• Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)

Other

• A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process
• In other cases where the investigator determines that participation in the clinical trial is inappropriate due to ethical reasons or the possibility of influencing the results of the clinical trial

• Children and adolescents aged 5 to 12 years at the time of screening
• Diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)\* by a psychiatrist according to DSM-5 diagnostic criteria
  • \*For ASD, diagnosis can be supported by the Autism Diagnostic Interview-Revised (ADI-R) or the Autism Diagnostic Observation Schedule (ADOS), either version 1 or 2
• Full-Scale Intelligence Quotient (FSIQ) of 65 or higher
• Able to use the 'NDTx-02' installed on a tablet, alone or with the assistance of a guardian
• Able to comply with the recommended application schedule for the investigational device (6 weeks, 30 sessions, 5 times per week)
• Agree not to add or change any treatment/education/rehabilitation programs or medications, including Applied Behavior Analysis (ABA) or cognitive therapy, during the study period (continuation of pre-existing TAU \[Treatment-As-Usual\] is allowed)
• Participant and parent (or legal guardian) voluntarily decide to join the trial and provide written informed consent
• Participants willing to comply with the clinical trial procedures