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<p>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; <i>p</i> = 0.009), with improvements in inattention (<i>p</i> = 0.024) and hyperactivity/impulsivity (<i>p</i> = 0.015). These findings suggest statistically significant improvements of small-to-moderate magnitude (<i>ηp</i>² = 0.05) in clinician-rated ADHD symptoms, along with favorable adherence and tolerability. Trial registration: ClinicalTrials.gov (NCT07173439).</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月27日

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  • Sojung Lee,
  • You Bin Lim,
  • Wooseok Choi,
  • Sohyun Park,
  • Bo-Ram Han,
  • Seonyoung Lee,
  • Suhjung Lee,
  • You Kyung Lim,
  • Seungbee Lim,
  • Eunice Jiun Chung,
  • Dongwon Kang,
  • Inyoung Son,
  • Jungsang Min,
  • Johanna Inhyang Kim,
  • Bung-Nyun Kim

摘要

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).