A Multi-center, Prospective, Compared, Randomized, Evaluator-blinded, Pilot Study to Evaluate the Effectiveness of Digital Therapeutics 'NDTx-02' on Executive Function in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)
The purpose of this study is to explore the preliminary safety and effectiveness of the digital therapeutic device 'NDTx-02' in supporting improvements of executive function in children and adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD).
• 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