Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD

Scott H Kollins,Andrew C Heusser,Jacqueline Lutz,Ann Childress

doi:10.1038/s41746-021-00429-0

Abstract

STARS-Adjunct was a multicenter, open-label effectiveness study of AKL-T01, an app and video-game-based treatment for inattention, as an adjunct to pharmacotherapy in 8–14-year-old children with attention-deficit/hyperactivity disorder (ADHD) on stimulant medication (n = 130) or not on any ADHD medication (n = 76). Children used AKL-T01 for 4 weeks, followed by a 4-week pause and another 4-week treatment. The primary outcome was change in ADHD-related impairment (Impairment Rating Scale (IRS)) after 4 weeks. Secondary outcomes included changes in IRS, ADHD Rating Scale (ADHD-RS). and Clinical Global Impressions Scale—Improvement (CGI-I) on days 28, 56, and 84. IRS significantly improved in both cohorts (On Stimulants: −0.7, p < 0.001; No Stimulants: −0.5, p < 0.001) after 4 weeks. IRS, ADHD-RS, and CGI-I remained stable during the pause and improved with a second treatment period. The treatment was well-tolerated with no serious adverse events. STARS-Adjunct extends AKL-T01’s body of evidence to a medication-treated pediatric ADHD population, and suggests additional treatment benefit.

Highlights

Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder of persistent impaired attention, hyperactivity, and impulsivity that negatively affects daily functioning and quality of life
A previous randomized controlled trial (STARS-ADHD), for example, demonstrated AKL-T01, a video-game based digital therapeutic, administered for 4 weeks at home, significantly improved attentional functioning as measured by the Test of Variables of Attention (TOVA®) in children diagnosed with ADHD, and a greater proportion of children on AKL-T01 showed evidence of improved ADHD-related impairment (IRS)[14] compared to a digital control intervention after 4 weeks of treatment
Despite severe comorbidities being exclusionary, around 20% of the included participants still presented with at least one comorbidity according to DSM

Summary

Introduction

Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder of persistent impaired attention, hyperactivity, and impulsivity that negatively affects daily functioning and quality of life. Front-line treatment for ADHD includes pharmacological and non-pharmacological interventions, which have demonstrated short-term efficacy[4,5,6]. There are limitations to both modalities of treatment[7,8,9,10,11,12,13]. Digital therapeutics may offer improved access, minimal side effects, and low potential for abuse while providing targeted treatment options for improving cognitive functions, such as attention. A previous randomized controlled trial (STARS-ADHD), for example, demonstrated AKL-T01, a video-game based digital therapeutic, administered for 4 weeks at home, significantly improved attentional functioning as measured by the Test of Variables of Attention (TOVA®) in children diagnosed with ADHD, and a greater proportion of children on AKL-T01 showed evidence of improved ADHD-related impairment (IRS)[14] compared to a digital control intervention after 4 weeks of treatment.

Methods

Results

Conclusion