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A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled

Scott H Kollins1, Denton J DeLoss2, Elena Cañadas2

  • 1Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA; Duke Clinical Research Institute, Durham, NC, USA.

The Lancet. Digital Health
|December 18, 2020
PubMed

Insights

This study shows that AKL-T01, a digital therapeutic, improved attention in children with ADHD. The treatment was well-tolerated, with minimal side effects observed in the trial.

Area of Science:

  • Neuroscience
  • Digital Therapeutics
  • Pediatric Health

Background:

  • Attention-deficit hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder impacting children and families.
  • Digital therapeutics offer novel approaches to address cognitive deficits in ADHD, potentially overcoming barriers to traditional treatments.
  • AKL-T01 is an investigational digital therapeutic designed to improve attention and cognitive control in pediatric ADHD patients.

Purpose of the Study:

  • To evaluate the efficacy of AKL-T01 in improving attentional performance in pediatric patients diagnosed with ADHD.
  • To assess the safety and tolerability of AKL-T01 in the target population.

Main Methods:

  • The Software Treatment for Actively Reducing Severity of ADHD (STARS-ADHD) trial was a randomized, double-blind, controlled study.
  • Paediatric patients (8-12 years) with ADHD and low TOVA API scores were randomized to AKL-T01 or a digital control.
  • The primary outcome was the change in Test of Variables of Attention (TOVA) Attention Performance Index (API) from baseline to post-intervention.

Main Results:

  • A statistically significant improvement in TOVA API was observed in the AKL-T01 group compared to the control group (p=0.0060).
  • The mean change in TOVA API was 0.93 in the AKL-T01 group versus 0.03 in the control group.
  • AKL-T01 demonstrated a favorable safety profile, with mild, infrequent adverse events such as frustration and headache.

Conclusions:

  • AKL-T01 shows promise as a digital intervention for improving objectively measured inattention in pediatric ADHD.
  • The digital therapeutic was well-tolerated, with minimal adverse events reported.
  • Further research is warranted to fully establish the role of AKL-T01 in ADHD management.
Abstract

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