Exploratory study of dual-task digital device in children and adolescents with attention-deficit/hyperactivity disorder

Aim: The study aimed to assess the efficacy and safety of SDT-001, a digital therapeutic, in Japanese children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Methods: This phase 2, multicenter, randomized, double-blind, sham-controlled study (jRCT1080225158) was conducted for a duration of up to 14 weeks. After screening, eligible participants were randomized to receive SDT-001 or single-task intervention for 25 min/day for 6 weeks and followed for 4 weeks after the intervention. A post hoc analysis was also performed to compare the effects of SDT-001 or a single-task to a nonrandomized, open-labeled, observational group (as the reference follow-up group; without single- or dual-task training; and continuing psychosocial treatment, including environmental adjustment). Results: Overall, 262 participants were enrolled in the study between July 2020 and July 2021. Of these, 261 participants were included in the analysis (SDT-001, n = 108; single-task, n = 107; observation, n = 46). ADHD Rating Scale-IV (ADHD-RS-IV) scores (physician's assessment) decreased gradually, with greater reduction in SDT-001 versus the single-task group at week 6 (ADHD-RS-IV-Total score, least-squares mean change from baseline [95% confidence interval] -7.5 [9.0, -6.1] vs. -6.5 [-7.9, -5.0], P = 0.2112). Reductions in inattention and hyperactivity/impulsivity scores were maintained during 4-week follow-up after treatment completion. At week 6, the scores of both groups improved compared to the nonrandomized observation group in post hoc analysis. Conclusion: These findings suggest SDT-001 as a promising treatment option, addressing the challenges of psychosocial treatment and pharmacotherapy in Japanese children and adolescents with ADHD.