JMIR Publications

ABSTRACT

Background:

Game-based digital therapeutics may provide scalable adjunctive support for children with attention-deficit/hyperactivity disorder (ADHD), but findings from one product cannot be generalized to another because serious games differ in task design and intervention context. Focus Run is a tablet-based serious game using an adaptive dual-task paradigm combining sensorimotor navigation with perceptual discrimination and response inhibition.

Objective:

To evaluate the feasibility, safety, usability, and preliminary outcome patterns of a 4-week home-based Focus Run intervention in Chinese children with ADHD.

Methods:

This prospective single-arm, open-label pilot study recruited a convenience sample from the pediatric rehabilitation outpatient clinic of Shanghai Children’s Hospital between June 15 and July 22, 2025. Eligible children were aged 4 to 14 years, had a specialist clinician diagnosis of ADHD according to DSM-5, had a full-scale IQ score greater than 80, and could complete training with caregiver support. Focus Run was delivered on an 8.4-inch tablet and prescribed as 25 minutes per day, 5 days per week, for 4 weeks. Assessments were conducted at baseline and week 4. Training logs were recorded automatically, and weekly telephone follow-ups monitored adherence and adverse events. The post hoc specified primary clinical outcome was change in SNAP-IV total score. Secondary exploratory outcomes included WFIRS, BRIEF, DCT, and BOKE STARS. Within-participant changes were analyzed using paired t tests or Wilcoxon signed-rank tests. Two-sided P<.05 was considered significant for the primary outcome, with Benjamini-Hochberg correction applied across the secondary outcomes.

Results:

Of 30 children assessed, 27 were enrolled and 25 completed the week-4 assessment, corresponding to a completion rate of 92.6% (25/27; 95% CI 75.7%-99.1%). The analyzed sample had a mean age of 7.56 years (SD 1.45); 20 of 25 participants were male (80.0%; 95% CI 59.3%-93.2%), 15 had combined presentation ADHD, 10 had inattentive presentation ADHD, and 24 were medication-naïve (96.0%; 95% CI 79.6%-99.9%). The SNAP-IV 26-item total score decreased from 43.64 (SD 10.09) to 33.76 (SD 9.89), with a mean difference of 9.88 points (95% CI 6.48 to 13.28; P<.001; Cohen’s dz=1.20, 95% CI 0.67 to 1.71). Secondary outcomes showed selective FDR-adjusted changes in WFIRS Life Skills and Social Activities, selected BRIEF scores, selected DCT indices, and BOKE STARS raw reaction time. The mean adherence was 110.66% of the prescribed training duration (SD 10.13 percentage points; range 93.35%–135.74%). No serious adverse events or discontinuations due to adverse events occurred.

Conclusions:

Focus Run showed acceptable short-term feasibility, adherence, tolerability, and usability, with preliminary decreases in parent-reported ADHD symptoms and exploratory changes in selected outcomes. This study provides product-specific pilot evidence for a home-based adaptive dual-task serious game delivered without standardized adjunctive behavioral parent training. These findings inform outcome selection, intervention optimization, and future randomized controlled trials and suggest potential value as a scalable home-deliverable adjunctive intervention. Clinical Trial: The trial was registered with the Chinese Clinical Trial Registry on June 10, 2025, before enrollment of the first participant on June 15, 2025 (ChiCTR2500104023; https://www.chictr.org.cn/showproj.html?proj=276012). No separate prespecified statistical analysis plan was registered. The SNAP-IV 26-item total score was selected post hoc as the primary clinical outcome, and WFIRS, BRIEF, DCT, and BOKE STARS outcomes were analyzed as secondary exploratory outcomes. No major deviations from the planned intervention delivery procedures occurred. Deviations related to outcome specification and reporting are described below.