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What kind of video game is being studied?
EndeavorRx, previously studied under the names Project:EVO and AKL-T01, is prescription software delivered as an adaptive video-game experience on a mobile device. Its algorithms adjust task difficulty as a child plays. The FDA-reviewed regimen is about 25 minutes a day, five days a week.
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This is not evidence for commercial games generally, nor for “brain-training” apps as a category. The FDA’s 2020 De Novo review describes the original indication for children ages 8–12 with primarily inattentive or combined-type ADHD and a demonstrated attention issue. The manufacturer’s current research and safety page lists ages 8–17; that current age range should not be confused with the population described in the original FDA-reviewed evidence.
What did the three studies find?
The title’s “three studies” does not identify a unique set: the FDA review describes five clinical studies. These three illustrate both the positive attention findings and the differences in how they were obtained.
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1. STARS-ADHD: the pivotal controlled trial
The FDA’s 2020 review reports that 348 children ages 8–12 with demonstrated attention issues were randomized to EndeavorRx or a digital control for four weeks. The primary outcome was change in the Attention Performance Index (API) on the Test of Variables of Attention (TOVA), a computer-based attention test. The treatment group’s API improved by 0.93 points, compared with 0.03 points in the digital-control group (p=0.006).
This supports an effect on that specified measure in the studied group. Participants were off ADHD medication at baseline, and the result does not establish broad remission of ADHD or improvement in every symptom. The manufacturer also reports that 73% of children in the pivotal study said their attention improved in an exit survey; that is manufacturer-reported survey data, distinct from the trial’s primary objective test outcome.
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2. STARS-Adjunct: treatment alongside stimulant medication
The FDA describes a treatment month, a one-month pause, and a second treatment month in a study of children who were on or off stimulant medication. The manufacturer reports that 68% of parents reported improved ADHD-related impairment after two months. This is a parent-reported measure presented on the company’s research page, not a general response rate or proof that the software works better than medication.
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Forty children with ADHD and 40 healthy controls completed a four-week at-home intervention. The FDA reports a mean TOVA API improvement of 1.43 in the ADHD group (p=0.03), with no significant change in controls. Unlike STARS-ADHD, this was not described as a randomized comparison against a digital control, so it provides a different and less direct basis for judging treatment effect.
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What does “improvement” mean here?
The FDA’s indication focuses on attention function measured by computer-based testing. In its De Novo summary, the FDA says: “Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity.” In practical terms, a better score on a sustained- and selective-attention test is not the same as demonstrating that a child’s overall ADHD symptoms, school functioning, or daily life have improved.
The studies summarized here do not provide a head-to-head comparison with medication, behavioral therapy, or another digital treatment. They also do not establish that the game should be used alone. The FDA labeling says EndeavorRx is not a substitute for medication; it is framed as part of a therapeutic program.
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Safety, cautions and suitability
The FDA’s 2020 review reports no serious adverse events in its clinical studies. Across 538 EndeavorRx-treated participants, 50 (9.3%) experienced treatment-related adverse events, generally described as transient. Separately, the manufacturer reports that 17 of 342 participants (4.97%) in two trials supporting the age 8–17 authorization experienced treatment-related events, including decreased frustration tolerance and headache. These figures use different participant groups and trial groupings, so they should not be treated as interchangeable estimates.
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How to interpret the evidence as a parent
- Keep the claim specific: the clearest controlled finding is improvement on a defined computer-based attention measure, not proof of a cure or resolution of all ADHD symptoms.
- Check what was actually studied: EndeavorRx is a prescription adaptive software product; the findings do not transfer automatically to ordinary video games or other apps.
- Ask how it fits the care plan: the FDA labeling does not present it as a medication replacement, and the evidence here does not establish comparative superiority over medication or behavioral therapy.
- Discuss risks and practical fit: ask the child’s healthcare provider about the cautions, device use, and how progress will be assessed.
Sources and further reading
- U.S. Food and Drug Administration: De Novo Summary DEN200026 (2020) — indication, trial designs, outcomes, labeling and safety findings.
- EndeavorRx manufacturer: Research and safety information — current posted age range, safety language and company-reported survey figures.
- ClinicalTrials.gov: NCT05991167 — prospective registry intended to describe real-world prescribing, treatment patterns and outcomes; a registry record is not itself proof of efficacy.
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