A recent clinical study published in Nature Scientific Reports indicates that MindPro1, a digital therapeutic intervention, shows promise in treating Attention Deficit Hyperactivity Disorder (ADHD) in children. The study, involving 52 participants aged 8.50 ± 1.38 years, assessed the effectiveness and safety of MindPro1 over a 4-week period. The results suggest that the digital therapy can significantly improve ADHD symptoms and cognitive performance.
Efficacy of MindPro1
The primary efficacy endpoint was the treatment response rate based on the 18-item SNAP-IV-Parent Scale, with a response defined as a ≥30% improvement from baseline. The Full Analysis Set (FAS) showed a response rate of 46.15% (95% CI: 32.23-60.53%). In the Per Protocol Set (PPS), the response rate was 50% (95% CI: 35.56-65.44%).
"The lower limit of the 95% confidence interval of the response rate in this study is ≥ the target value of 27.5%, which is better than the overall response rate of 27.2% of the similar American product EndeavorRx® under the same conditions," the study authors noted.
Secondary efficacy indicators also showed significant improvements. The SNAP-IV scores improved significantly after 4 weeks of intervention (p < 0.001), and the TOVA-ACS scores also showed statistically significant improvement (P < 0.05).
Parental Acceptance and Compliance
An overwhelming majority (100%) of parents reported acceptance of the MindPro1 treatment, indicating high satisfaction with the intervention. The average compliance rate was 89% ± 23% in the FAS and 95% ± 12% in the PPS, demonstrating good adherence to the digital therapy regimen.
Safety Profile
The safety evaluation revealed that 19.23% of participants experienced mild adverse events, with only 7.69% potentially related to the device. These events were resolved by suspending training and observation for 2 days. Importantly, no serious adverse events or game addiction were reported.
Study Details
The study enrolled 52 children with ADHD, with a male to female ratio of 6.4:1. The baseline SNAP-IV score was 35.31 ± 8.56, and the baseline TOVA-ACS score was -3.16 ± 3.11. The primary outcome measure was the change in SNAP-IV-Parent Scale score after 4 weeks. Secondary outcomes included changes in TOVA-ACS scores, parental acceptance, and compliance rates.
Implications
These findings suggest that MindPro1 could be a valuable non-pharmacological intervention for managing ADHD symptoms in children. The high parental acceptance and compliance rates further support its potential as a practical and well-received treatment option. Further research with larger sample sizes and longer follow-up periods is warranted to confirm these findings and explore the long-term benefits of digital therapy for ADHD.
