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

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

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.

Conflict of interest statement

Akili Interactive Labs provided research support for this study and played a role in the conceptualization and design of the trial and in the decision to publish and manuscript preparation. In addition, the authors declare the following employment and financial interests: J.L. and A.C.H. are Employees at Akili Interactive and own Stock or Equity. S.H.K. is a Consultant for Akili Interactive, owns Stock or Equity, and received Research support. A.C. served on the Advisory Board and received Research support. The views and opinions expressed within this manuscript are those of all the authors and do not necessarily represent those of the sponsor.

Figures

Fig. 1. Trial Consort Table.
Fig. 1. Trial Consort Table.
Of the three AE-related withdrawals, one was coded as AE, two were coded as subject withdrawal (one in stimulant, one in no stimulant cohort).
Fig. 2. Clinical measures of ADHD symptoms…
Fig. 2. Clinical measures of ADHD symptoms (ADHD-RS) and ADHD-related impairment (IRS) improve with AKL treatment and remain stable during a 4-week treatment pause.
▴Primary outcome in the STARS-Adjunct trial was the change in IRS from baseline (BL) to Day 28 in the two cohorts. Data distribution for each group and time point is displayed in Supplementary Fig. 1.
Fig. 3. STARS-Adjunct study overview.
Fig. 3. STARS-Adjunct study overview.
The figure shows a schematic of the design of the current study.

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