FDA Permits Marketing of Digital Game to Improve Attention in ADHD Children (2020)

https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd

by luu • 2 years ago

41 19 2 years ago

fda.gov

tech234a• 2 years ago

(2020)

qdot76367• 2 years ago

Akili Interactive, who made the product this 2020 report is about, eventually SPAC’d their way public but ended up being sold off to private equity in March 2024.

https://www.fiercebiotech.com/medtech/adhd-game-developer-ak...

iterance2• 2 years ago

Is there independent clinical data to support this approach? Surficially the gameplay looks like a slightly less enjoyable version of Mario Kart. This says the FDA "reviewed data," but not that it found the data compelling, only that the risks associated were minor.

doctorpangloss• 2 years ago

Yes: https://www.thelancet.com/journals/landig/article/PIIS2589-7...

If you are looking for a flaw in the study, it's that they compared their game to Boggle. I mean they don't call it that, but that sounds like what it is.

The control was designed to match AKL-T01 on expectancy, engagement, and time on task in the form of a challenging and engaging digital word game, targeting cognitive domains not targeted by the AKL-T01 intervention and not primarily associated with ADHD. The user was instructed to find and connect letters on a grid to spell words; points are awarded on the basis of number of words formed, word length, and the use of unusual letters.

Would it have performed as well if it were compared to a game that is more popular with kids? Average age was 9.7 years. 10 year olds do not like Boggle or word games. They like Fortnite, which was massively popular when this was released.

Does Fortnite reduce ADHD? I don't know. I know for sure kids hate boggle. But Fortnite is free, this treatment is not. It's monumental that they got a game approved for medicine. But the reality, as it bore out, is that regular, top commercial games probably also "treat" ADHD. They probably "treat" a ton of problems kids have.

iterance2• 2 years ago

Well, in this case the control does not really match the treatment group at all, so I would suggest that may be a serious flaw. If the hypothesis is that the proprietary algorithm is responsible for the change in the treatment group, it is an odd choice to use an entirely different game as a control, rather than the same game with the proprietary adaptive algorithm removed. (Evidently it is possible to remove just the algorithm, as the demo version lacks the treatment algorithm.) I'm a bit skeptical of the utility of the study.

(I also take minor issue with a study "sponsored by Alkili" being reasonably construed as independent, given that "the funder had a role in study conception and design, confirming data and statistical analyses, and conducting the study." But this of course does not necessarily invalidate the underlying science.)

mrguyorama2• 2 years ago

AKL-T01 is an investigational digital therapeutic that uses a proprietary algorithm designed to improve attention and related cognitive control processes, by training interference management at an adaptive and personalised high degree of difficulty. Interference is instantiated through a video game-like interface displaying two tasks that are to be done in parallel (multitasking): a perceptual discrimination targeting task in which users respond to the instructed stimulus targets and ignore the stimulus distractors (similar to a Go–No-Go task) and a sensory motor navigation task in which users continuously adjust their location to interact with or avoid positional targets.

It seems the crux of their "tech" is simply a game that tries to get you to balance your focus between two tasks and punish/reward you for performance on that. Reviews claim the game feels like it was thrown together in a couple weeks because it probably was, because "multitask two different things and train yourself to manage the distractions they produce" is such a trivial concept that it already exists as at least one video game I know of (https://store.steampowered.com/app/640290/Super_Multitasking...) and it's been a genre for at least decades, and the only novelty they have introduced is an "algorithm" that is most likely "as they succeed at managing the distractions, make it harder", otherwise known as "dynamic difficulty" which goes back to at least the mid-2000s.

People rarely play these games for fun because practicing managing your attention is really hard and stressful and is basically the opposite of what most people are doing video games for. The reviews for example point out that the game is extremely hard very quickly, and they don't seem to realize that's the point: To explicitly challenge your ability to respond to distractions as practice.

Most games IMO do not fit this pattern enough to help ADHD. Further looking, I see their entire test of outcomes was a singular ADHD test called "TOVA", which primarily tests reaction time to a stimulus.

So, their paper (not an independent study BTW) says that if you play a game that challenges your reaction time for 20 minutes every day, you will do better on a test that asks you to have good reaction time for 21.6 (why) minutes.

Wow

IMO selling such a game as a subscription and "medicine" is pretty abhorrent. The only reason to do so is to charge absurd prices for a very simple game.

Animats2• 2 years ago

"The current cost for EndeavorRx is $99 for a 30 day prescription."[1]

Here's what it looks like.[2] Very 1990s.

[1] https://www.endeavorrx.com/

[2] https://www.youtube.com/watch?v=wCXKNCKTmTg

meowster2• 2 years ago

The "adult verson" looks like it has the same 30 second commercial, is OTC (no prescription-needed), and is only $130/year or $25 for just one month.

https://www.endeavorotc.com

mrguyorama2• 2 years ago

I posted elsewhere an excerpt from their paper. Their game looks like a demo you'd create following a tutorial because it basically is.

The crux of their tech is just a game where you juggle two tasks and get distractions thrown at you, and the better you do, the more it tries to distract you. They probably barely modified a few stock assets and added a single chunk of code to implement that dynamic difficulty.

It really makes me want to re-implement this exact project. It's literally a weekend thing.

Of note, their test they supposedly improved on was TOVA, "Test of variable attention", and anecdotally more so tests your ability to stay focused on a response time test.

That is not confidence inspiring. Being able to do better on a response time test after playing a game that challenges your response time at higher difficulties is not new science. This also does nothing for those like me with utterly broken executive functioning.

blueyes• 2 years ago

I play this game.

https://www.endeavorotc.com

Duke replicated Gazzaley's results.

The first section of his book is good at explaining attention:

https://www.amazon.com/Distracted-Mind-Ancient-Brains-High-T...

drilbo• 2 years ago

I remember learning about this a few years ago and being really interested, then I read the reviews on Google Play

https://play.google.com/store/apps/details?id=com.akiliinter...

Edit: seems they've added a (also terrible) version for adults: https://play.google.com/store/apps/details?id=com.akiliinter...

0xEF• 2 years ago

Maybe I am misreading, but I am seeing mostly bad reviews complaining that the app can only be installed on a single device? Otherwise the game/treatment has a net positive effect?

meowster2• 2 years ago

It looks like the adult version which doesn't require a prescription has in-game purchases (Google Play subscription?), so assuming it was bought that way, it seems like it wouldn't be restricted to one device. I can see the kid version being restricted if they only sell prescriptions outside of the Play Store.

I wonder what the difference is between the adult and kid versions, just the prescription requirement maybe?

userbinator• 2 years ago

The most common adverse events observed with EndeavorRx are: frustration, headache, dizziness, emotional reaction, and aggression.

I'm sure all of us who've played any games at all have experienced those. Especially the first one.

AStonesThrow• 2 years ago

Imagine if the FDA were tasked with cataloging and publishing side effects reported from any and all video games.

https://youtu.be/GmqeZl8OI2M?si=M9fYsW_S3sMm5pNl

gonn• 2 years ago

This seems like a privacy nightmare. If this is aimed at teenagers there shouldn't share any data with third parties IMO. Then again https://www.akiliinteractive.com/privacy-notice#consumer-hea...

I can't see many people trying to defend this for the sake of "move fast, break things".

hulitu• 2 years ago

FDA Permits Marketing of Digital Game to Improve Attention in ADHD Children (2020)

Aren't all games "stealing" attention ?

Spivak• 2 years ago

From https://news.ycombinator.com/item?id=42010939

It seems the crux of their "tech" is simply a game that tries to get you to balance your focus between two tasks and punish/reward you for performance on that.

If you have ADHD and want to give this a shot with more fun games here's some recommendations.

* PlateUp — run a restaurant managing the cooking and serving simultaneously. Hacker friendly with fun automation.

* Binding of Isaac / Enter the Gungeon — run based bullet hell games, huge amounts of novelty, dodging and attacking are related but mostly independent tasks.

* Don't Starve (Together) / Oxygen Not Included — manage a huge amount of resources trying to not get killed by the environment, lots of tasks you have to balance simultaneously.

* FTL — be a Star Trek captain. Lots of things you have to do simultaneously and you get a pause button.

* Starcraft (PvP) / They Are Billions (PvE) — Real time base builders.

Source: Have ADHD and love these games for the task balancing.

FDA Permits Marketing of Digital Game to Improve Attention in ADHD Children (2020)

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