Peer-reviewed article
Cross-training digital therapeutics for pediatric ADHD: study protocol for a randomized controlled trial.
Zhao X, Cai Y, Zhang X, Xu T, Qian Y et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a study protocol for a randomized controlled trial testing digital therapeutics (game-based computer and smartphone treatments) for children aged 6-12 with ADHD. The trial will compare three groups: children receiving digital training alone, medication alone, or both together, measuring improvement in ADHD symptoms over 8 weeks. The digital treatment combines neurofeedback and executive function training to address multiple aspects of ADHD. The study aims to determine whether digital therapeutics could offer a non-pharmacological alternative or supplement to medication for managing ADHD in children.
Key points
- 210 children will be randomly assigned to three groups: digital therapeutics only, medication only, or both combined
- The digital therapeutics use a cross-training approach integrating neurofeedback and executive function training delivered via home-based computers and smartphones
- Primary outcome is change in SNAP-IV total score (measuring core ADHD symptoms) from baseline to 8 weeks
- Non-inferiority testing will determine if digital therapeutics are as effective as medication; superiority testing will assess if combining both approaches is better than medication alone
- The study aims to provide evidence for non-pharmacological intervention or supplementary treatment options for pediatric ADHD
Limitations
This is a study protocol describing a planned trial, not results. The document does not provide any actual outcome data, participant demographics, baseline characteristics, or information about the specific digital therapeutics being tested. The effectiveness of the intervention remains unknown until the trial is completed.
Abstract
Background Attention-deficit/hyperactivity disorder (ADHD) in children can result in academic and occupational failure, poor socialization, and an increased risk of accidental injuries. Digital therapeutics (DTx) leverage computers and smartphones to provide game-based treatments targeting ADHD's cognitive and behavioral aspects. Although the evidence base for DTx in ADHD is expanding, most DTx focus on a single mechanism without leveraging potential synergies between them. This study aims to evaluate the effectiveness of a cross-training DTx for children aged 6-12 with ADHD. Methods The DTx study is a multicenter, open-label, randomized controlled trial that employs a cross-training approach integrating neurofeedback and executive function training. A total of 210 participants will be randomly assigned to one of three groups: the medication group (MED), the DTx group (DTX), or the combination group (COM). DTX will receive home‑based digital training, MED will receive methylphenidate, and COM will receive both. The primary outcome is change in Swanson, Nolan, and Pelham Rating Scale (SNAP‑IV) total score from baseline to 8 weeks post-randomization. Non‑inferiority will be tested between DTX and MED with a non-inferiority margin of Δ = 4 points; superiority between COM and MED will be defined as the lower bound of the two‑sided 95% confidence interval for the difference being greater than 0. Discussion The clinical trial protocol presented here outlines a randomized controlled trial that evaluates DTx utilizing cross-training approach. The aim of this trial is to assess the efficacy and acceptability of the cross-training DTx for children aged 6 to 12 years with ADHD. The primary outcome is the degree of improvement in the core symptoms of ADHD (measured by SNAP‑IV). Additionally, we will evaluate compliance and potential side effects associated with the DTx. The results of this study may provide an optional non-pharmacological intervention/supplementary treatment option for children with ADHD. Trial registration NCT06369714. Registered on 17 April 2024. https://clinicaltrials.gov/study/NCT06369714 .
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Cross-training digital therapeutics integrating neurofeedback and executive function training, delivered via home-based computers and smartphones
- Population
- Children aged 6-12 years with ADHD
Key finding
Study protocol registered (NCT06369714) but no results yet available