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FDA Approves First-Ever Video Game Treatment for ADHD

But don’t throw away all the established approaches just yet.

Up until now, video games have been seen more as the problem rather than the solution when it comes to attention skills in children and those who meet criteria for Attention Deficit Hyperactivity Disorder (ADHD). On June 15, 2020, however, the FDA gave approval for the first video game treatment, more technically called a “game based digital therapeutic device,” for the treatment of ADHD. The approval came after a series of clinical trials with one of the more prominent ones being published very recently in the journal Lancet Digital Health.

The program or game, now called EndeavorRX but formerly known as AKL-T01, involves steering various crafts through obstacle courses as you try to collect targets and avoid hazards like fire pits or underwater mines. It’s designed to help children stay develop improved abilities to sustain attention, filter out distractions, and efficiently shift from one task to another. Originally, it required a physician prescription, although apparently this requirement has been waived during COVID.

The manufacturer, Akili Interactive, reports that it has been tested in more than 600 children already, with many of them described in this Lancet Digital Health study, funded by Akili Interactive, that involved 20 different sites and 348 children between the ages of 8-12 with a confirmed diagnosis of ADHD.

Unlike most treatment studies of ADHD, however, the primary variable of interest wasn’t a rating scale of ADHD symptoms as judged by a parent, teacher or doctor but rather the score on a computerized test of attention called the Test of Variables of Attention (TOVA). Even more, subjects were not allowed entry into the study unless they performed sufficiently badly on this computerized test, even if they had a confirmed diagnosis of ADHD. The more typical rating scales of ADHD symptoms were obtained but, prior to the study’s start, were deemed secondary measures.

The subject’s design was a rigorous randomized double-blind design to limit bias in ratings between how subjects improved between the AKL-T01 treatment and a control condition that consisted of playing various word games on an Ipad. Subjects were randomized to either the control or AKL-T01 condition and instructed to do each for 25 minutes each day, 5 days a week, for 4 weeks.

At the end of the study, all subjects did the TOVA again. Those who had been “playing” the ALK-T01 program saw a 1-point improvement in their TOVA score (from a baseline of about 5) while those in the control condition had virtually no improvement at all. This difference was statistically significant. However, the measures of ADHD symptoms rated by parents or clinicians showed little difference between the AKL-TO1 group and the control group and were not statistically significant. For example, a more global rating scale of ADHD symptoms as rated by parents showed that 24% of children the ALK-T01 had a substantive improvement in symptoms (which meant at least a 30% reduction in total score) versus 19% in the control group.

Side effects in both groups, as might be expected, were mild and consisted of things like frustration and headache in about 2-3% of the participants.

The authors of the study concluded that there was enough evidence to support the use of game as something that could improve at least objectively rated attention measures but not enough to recommend it as an alternative for more established treatments.

The approval of EndeavorRx will likely be welcome news to many parents and clinicians. While medications are often used for ADHD and can be effective, they certainly can have some significant side effects, and some youth show little improvement. Some types of psychotherapy are also effective, as can engaging in some healthier behaviors related to things like exercise and sleep, though who wants to do that when you can just play a video game instead?

Not so fast. Before getting too excited, it important to keep in mind a few things about this study. First, the lack of improvement in more global assessments of ADHD is a problem and suggests a limitation that has plagued other supposedly therapeutic games designed to boost cognition which is that it can be hard to demonstrate that people get better at much more than the game itself. Secondly, one might argue in this trial that the study “stacked the deck” by not enrolling ADHD subjects who had the diagnosis but didn’t do sufficiently poorly on a computerized attention measure before being given a computerized treatment.

All told, this is an intriguing option that I’m sure we’ll learn more about as the game becomes more widely used. In the meantime, I’ll keep talking to patients and their families about things like increasing physical activity and sleep, good nutrition—and, somewhat ironically, reducing screen time.


Kollins SH, DeLoss DJ, et al. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomized controlled trial. Lancet Digital Health 2020: Volume 2, Issue 4, E168-e178.