Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Dec 22, 2023
Date Accepted: Apr 25, 2024
A Digital Cognitive-Physical Intervention for Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial
ABSTRACT
Background:
Attention-deficit/hyperactivity disorder (ADHD) is prevalent among school children, often lead to functional impairment and co-occur with psychological disorders. The primary treatment for ADHD is pharmacotherapy, supplemented by behavioral interventions. While medication effectively manages symptoms in the short-term, adherence is impacted by concerns over effectiveness and dependency fears. Digital treatments offer an accessible alternative with fewer side-effects. Additionally, exercise therapy enhances ADHD children’s physical and psychological health, and haven been linked with improvements in neurocognitive and executive function (EF). However, the combined impact of digital and exercise therapies is still under research.
Objective:
To determine whether Brainfit, a novel digital cognitive-physical intervention can reduce ADHD symptoms and executive functions (EFs) in children with ADHD.
Methods:
In a single site pilot randomized controlled trial (ChiCTR2300070521), 90 children (6-12 years of age) who met the diagnostic criteria of ADHD (DSM-5) were randomized 1:1 to 12 sessions of Brainfit intervention (n=44) or a waitlisted control (n=46) between April and August 2022. Intervention was delivered in an outpatient clinic with iPads and under clinician supervision. The primary outcomes were parent-rated symptoms of attention, hyperactivity (SNAP-IV) and executive functions (BRIEF), evaluated at pre- and post- intervention. The intention-to-treat analysis was performed on 80 children after attrition. The non-parametric resampling-based permutation test was used to conduct hypothesis testing of intervention effects.
Results:
Assessors were blinded to group assignments. At post-intervention, participants in the intervention group had a statistically significant improvement in ADHD symptoms (beta=-8.47, p=0.002), while participants in the control group showed a slight decline (beta=-0.28, p=0.002). There was no severe intervention-related adverse event.
Conclusions:
These findings support the benefit of a novel digital cognitive-physical intervention for children with ADHD. A larger efficacy trial with longer follow-up is warranted to confirm these findings and to assess durability of treatment effects. Clinical Trial: ChiCTR2300070521, https://www.chictr.org.cn/
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.