A Randomized Clinical Trial to Assess The Effectiveness and Safety of Digital Therapy for Treating Attention Deficit Hyperactivity Disorder in Children
This study is designed to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD. Investigators will also evaluate the safety of digital therapy for intervention treatment of childhood attention deficit hyperactivity disorder.
⁃ Age 8 years to 12 years, inclusive, at the time of parental informed consent.
⁃ Male or female.
⁃ Confirmed ADHD diagnosis , any presentation , at Screening based on DSM-V criteria and established via the MINI-KID administered by a trained clinician.
⁃ Screening/Baseline score on the clinician-rated ADHDRS-IV score 24.
⁃ Screening/Baseline score on the TOVA API -1.8.
⁃ Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening ; or, if undergoing pharmacolog ical treatment , must be willing and appropriate (i.e. not optimally treated in the investigator's judgment) to wash out of current regimen.
⁃ Estimated IQ score\
• 80 as assessed by Wechsler Intelligence Scale for Children-Fourth Edition ,WISC-IV.
⁃ Ability to comply with all the testing and requirements.