Currently submitted to: JMIR Serious Games
Date Submitted: Mar 7, 2026
Open Peer Review Period: Mar 10, 2026 - May 5, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy and Safety of Focus Run, a Game-based Digital Therapeutic for Children with Attention Deficit Hyperactivity Disorder: A Prospective Single-Arm Pilot Study
ABSTRACT
Background:
Attention-Deficit/Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental disorder. First-line treatments are often associated with adverse effects and limited accessibility. Game-based digital therapeutics (DTx) have emerged as promising adjunctive treatments.
Objective:
This pilot study aimed to evaluate the preliminary efficacy, feasibility, and safety of Focus Run, a novel game-based digital therapeutic (DTx) designed to improve core symptoms and executive function in Chinese children with ADHD.
Methods:
This prospective, single-arm pilot study enrolled 25 children aged 4–14 years with ADHD. Participants completed a 4-week home-based intervention using Focus Run (25 minutes/day, 5 days/week). We assessed outcomes at baseline and week 4, including parent-reported symptom and function scales (SNAP-IV, WFIRS, BRIEF), objective cognitive tests (DCT, BOKE STARS), and prefrontal hemodynamics measured by fNIRS during a Go/No-Go task. Changes from baseline to post-intervention were analyzed using paired t-tests or Wilcoxon signed-rank tests.
Results:
After the 4-week intervention, the SNAP-IV total score decreased significantly from baseline (mean reduction of 7.96 points; 95% CI -10.76 to -5.16; P < .001; Cohen's d = 1.17), with the largest effect size on the inattention subscale (Cohen's d = 1.30, P < .001). The response rate, defined as ≥30% improvement from baseline, was 40% for the inattention subscale and 20% for the total score. Significant improvements were also observed in specific domains of WFIRS and BRIEF (P < .05). The DCT showed improved accuracy (P < .001), and fNIRS revealed enhanced Go trial accuracy (P = .001) without significant hemodynamic changes. The intervention was highly feasible, with a mean adherence rate of 110.65% to the prescribed training duration. Three participants (12%) reported mild, transient visual fatigue; no serious adverse events occurred.
Conclusions:
This study provides preliminary evidence that Focus Run is a safe and effective digital therapeutic for improving core ADHD symptoms and specific executive functions in Chinese children, supporting its potential as a feasible adjunctive intervention. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2500104023; https://www.chictr.org.cn/showproj.html?proj=198625
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.