A Boston biotech firm has introduced a game it says is a “digital therapeutic” for ADHD behavior. However, experts are skeptical of its potential effectiveness.

Attention deficit hyperactivity disorder (ADHD) is one of the most common disorders among children in the United States.

The American Psychiatric Association estimates the disorder affects at least 5 percent of children in the country.

Children and adults with ADHD are easily distracted, have difficulty focusing for long periods of time, and behave impulsively.

According to the Centers for Disease Control and Prevention (CDC), ADHD is most commonly treated with stimulant medications, either Ritalin or Adderall, as well as behavior therapy honing skills, such as organization and time management.

A company called Akili Interactive, an affiliate of PureTech Health, is pioneering another potential option.

They’re focusing on digital therapeutics.

A video game the company has developed called AKL-T01 is designed to treat ADHD.

Company officials say they hope it becomes the first “prescription video game” for the disorder.

“Clinically validated digital therapeutics have the potential to rewrite our definition of medicine and improve patients’ lives, as standalone interventions or in association with other treatments,” Eddie Martucci, PhD, chief executive officer of Akili, wrote in an email to Healthline. “The technology in AKL-T01 has been shown in clinical studies to improve cognitive function, or our ability to filter distractions and make real-time decisions.”

Akili plans to file for clearance from the U.S. Food and Drug Administration (FDA) for AKL-T01 to be regulated as a medical device and be prescribed as a prescription treatment for ADHD, Martucci said.

“We are excited by the results of the study which we believe was one of the most rigorous clinical studies of a digital therapeutic to date,” Martucci said. “It’s an important first step but there is a lot more work to be done.”

The study by Akili involved 348 children between the ages of 8 and 12 who have received an ADHD diagnosis.

The children played “action-packed” video games on a tablet for 30 minutes a day, five days a week for four weeks, according to StatNews.

Some children were given AKL-T01 while others were given a different video game meant to serve as a placebo.

The children who played AKL-T01 saw “statistically significant improvements on metrics of attention and inhibitory control,” StatNews reported.

The game has players moving through lava and ice, activating “certain neural networks.”

However, parents and physicians “subjectively perceived about the same amount of improvement in children’s behavior whether they were playing the placebo game or the therapeutic game,” StatNews wrote.

And that lack of a marked behavioral difference is particularly important when it comes to ADHD treatment, Lara Honos-Webb, PhD, author of “The Gift of ADHD: How to Transform Your Child’s Problems Into Strengths,” told Healthline.

“There’s a really big difference between a statistically significant finding and a clinically significant finding,” said Honos-Webb.

She cited as an example a person who drinks eight beers a day and then begins drinking seven beers a day.

That person has made a statistical improvement but not a behavioral improvement. They’re still drinking a lot.

“[In Akili’s study] neither the parents nor the physicians were able to distinguish who got the control condition and who got the actual treatment,” she noted. “And to me at the end of the day, that’s all that matters.”

Treating ADHD in children usually involves hands-on assistance from key adults in a child’s life, particularly when it comes to reinforcing behaviors and teaching skills.

“Typically speaking, when a child is diagnosed with ADHD, we find that the gold standard of treatment is a combination of medication, usually a stimulant medication, and behavioral therapy,” said Dylann Gold, PhD, clinical assistant professor in the department of child and adolescent psychiatry at Hassenfeld Children’s Hospital at NYU Langone.

“We usually very much have an ‘all hands on deck’ approach, meaning we involve the parents, the teachers, any sort of caregiver that’s with the child throughout the day,” she told Healthline.

Dr. Thomas Brown, former associate director of the Yale Clinic for Attention and Related Disorders and author of five books about ADHD in children, teens, and adults, noted that “pills do not teach skills.”

Although medication helps, it’s the reinforcement of skills that particularly help children.

“I would definitely advise parents to be skeptical” of a video game treatment, Brown told Healthline. “I think it’s just buying the kids another video game, and I do not think that it could reasonably be expected to produce any significant changes in the way in which the kid’s brain functions for dealing with things like reading assignments, paying attention in class, being able to organize ideas to write things down, [and] being able to explain things to other people.”

Brown is particularly skeptical of AKL-T01 as a treatment for ADHD given the complexity of the disorder.

He said Akili is “talking about attention as though it’s one thing that crosses all these different domains and that’s nonsense… The notion to have this prescribed for treatment of ADHD is just absurd.”

As a clinician, Honos-Webb agreed, saying she was skeptical that AKL-T01 could improve the behaviors that children with ADHD struggle with.

Those skills include organization, motivation, planning and prioritizing, time management, and persistence.

“Those are the things that parents might see,” Honos-Webb explained about observable behavioral changes. “And the other thing is in terms of translating this into the classroom. A classroom is a very different setting [than a video game] in terms of measuring attention because you’re in a setting where the information’s coming at you very slowly. There’s lots of distractions and you’re being asked to take a lot of information.”

Gold concurred that the real test of whether AKL-T01 can treat meaningfully pediatric ADHD is whether it improves these other behaviors in the classroom and at home.

“I’m waiting to hear more about how did [kids’] attention change at school? How did their grades change, how did their test scores change? How did they shorten their morning routine?” she said. “Those are the outcomes that I want to see, that I’m going to be looking for.”

Whether or not AKL-T01 is eventually approved by the FDA as prescribed treatment for ADHD, Honos-Webb noted that an abundance of screen time is a significant problem for her clients.

Prescribing video games for children who may already struggle with too much screen time — or even video game addiction — is sending “mixed messages,” she said.

“Video game addiction is so common with people with ADHD,” she said.

In fact, Honos-Webb is taking continuing education courses on video game addiction because it’s “a very, very significant problem” among her clients.

In a typical week’s caseload at her practice, she said she sees that in “a minimum 20 percent of ADHD kids that I’m treating, a significant additional thing that we’re treating is simply how to get them off of video games.”

The ADHD experts who spoke with Healthline also expressed concern over how a prescription video game for ADHD may be similar to “brain training” apps like Luminosity and CogMed — the latter of which proclaims it can improve concentration.

Though these products “tout themselves as helping with executive functioning and working memory and cognitive stuff,” Gold explained, research showing their efficacy “is pretty limited.”

Indeed, the consensus on CogMed, which has been studied for years, is mixed.

While it may not harm people who use it, it may not particularly help them in the long term, either.

A concern is that parents may spend time and money on products that may not particularly help their child’s ADHD.

“A lot of my clients have gone to… brain training centers,” Honos-Webb added. “But I know all the time, a lot of clinicians, myself included, [have] clients bring in these printouts that they get from the centers that say, ‘Oh, look how much your child’s attention and an inhibitory control has approved!’”

Honos-Webb continued, “And then the parents say, ‘But the teachers say this is meaningless because there’s no difference in the classroom,’ and the parents will say [the kids] are not doing their homework.”

With brain-training apps, “you get better at playing the games, but that doesn’t really translate to, like, having a better memory or better cognitive skills in real life,” Gold explained.

Over the past century, ADHD has largely been viewed as a behavioral problem, particularly the hyperactivity.

It’s only in the past several decades that medical practitioners are better understanding the brain science behind it.

“ADHD looks for all the world like it’s a willpower problem, when in fact it’s not,” explained Brown. “The direction that the science is moving in this is to recognize that ADHD is essentially a developmental impairment of the brain’s self-management system.”

One of the main complications in ADHD can be comorbidity with other mental health disorders, particularly anxiety and depression. This is often a result of children struggling from their attention issues.

“So many people who have ADHD also have learning disorders or problems with anxiety or problems with depression, problems with obsessive compulsive disorder,” said Brown. These issues “need additional help, possibly through behavior, behavioral interventions, or some psychotherapy or just tutoring and coaching.”

While stimulant medications for children with ADHD work for many, they don’t work for everyone.

“The best estimates are someplace between about 70 percent and 90 percent of individuals with ADHD experienced some significant improvement with the treatment with medicine, if the medicine is prescribed and carefully tailored to the individual’s body chemistry,” Brown said.

When stimulants don’t improve ADHD symptoms, there are some nonstimulant medications that can be prescribed as well, Brown said.

“And there are some people where none of the stuff we have works,” he said. “But that’s true in every field of medicine. Nothing we have works for everybody for anything.”

Still, parents of children with ADHD can be desperate to help their children, particularly when it comes to succeeding in the classroom.

In his email to Healthline, Martucci noted that some parents and physicians may want to prescribe a video game precisely because it’s not a drug.

“Physicians and parents of children with ADHD are looking for safe and effective alternatives to traditional pharmaceuticals,” he said.

“Many children are inadequately managed on medication, including tolerability concerns, and additionally a significant number of parents choose not to treat their children with traditional pharmaceuticals. For these children, AKL-T01 represents a promising potential new treatment option,” he added.