Multicenter randomized trial of a digital therapeutic game for executive function in children with ADHD

Significant executive function deficits mark attention-deficit/hyperactivity disorder (ADHD). Digital therapeutics (DTx) targeting cognitive control offer promising non-pharmacological options but require rigorous validation. We evaluated the efficacy and safety of STAR RUCKUS, an adaptive multitasking DTx designed to strengthen cognitive control in children with ADHD. In this multicenter, randomized, single-blind, sham-controlled trial, 122 children aged 6-12 years with DSM-5/ICD-10-diagnosed ADHD were assigned 1:1 to STAR RUCKUS or a visually matched driving-only sham intervention and completed five daily sessions for 4 weeks. The primary outcome was the change in clinician-rated Korean ADHD rating scale (K-ARS) scores. Of 122 randomized children, 114 completed the trial. At Week 4, STAR RUCKUS produced greater symptom reduction than sham (-7.50 vs. -4.00; p = 0.009), with improvements in inattention (p = 0.024) and hyperactivity/impulsivity (p = 0.015). These findings suggest statistically significant improvements of small-to-moderate magnitude (ηp² = 0.05) in clinician-rated ADHD symptoms, along with favorable adherence and tolerability. Trial registration: ClinicalTrials.gov (NCT07173439).