Trial reportTranslational psychiatry2024
Real-time cognitive performance metrics derived from a digital therapeutic for inattention predict ADHD-related clinical outcomes: Replication across three independent trials of AKL-T01.
Trial report in Translational psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Controlled, Parallel-group, Intervention Study to Assess At-home, Game-based Digital Therapy for Treating Pediatric Participants Ages 8 to 12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
A Single Arm Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adolescents, Aged 13-17 Years Old, Diagnosed With Attention Deficit Hyperactive Disorder (ADHD)
A Single Arm, Adaptive Design, Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adults Diagnosed With Attention Deficit Hyperactive Disorder
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Multimodal Digital Therapeutics Enhanced by Task Design and AI for Attention-Deficit/Hyperactivity Disorder Core Symptoms and Executive Functions in Children and Adolescents: Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.Journal of medical Internet research · 2026Pooled it
- Developing digital biomarker for predicting cognitive response to multi-domain intervention.Scientific reports · 2026Trial
- Data-driven mechanistic analysis of digital therapeutic-assisted training and evaluation of personalized protocol effects in children with attention deficit/hyperactivity disorder.Frontiers in psychiatry · 2026Trial
- Eye-Tracking-Based Digital Therapeutic for ADHD in Children: Development and Preliminary Evaluation of an Adaptive Learning Guide.Healthcare (Basel, Switzerland) · 2026Article
- The impact of electronic product use on children with tic disorders and ADHD, and management strategies: a review.Frontiers in psychiatry · 2025Review
- Personalized Game-Based Content and Performance: A Pilot Study on a Digital Intervention for Children with ADHD.Bioengineering (Basel, Switzerland) · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
AKL-T01 is a digital therapeutic (DTx) that targets attention by generating conflict at dynamically updated difficulty levels during a multitasking game. Clinical trials support AKL-T01's efficacy in attention-deficit/hyperactivity disorder (ADHD), but there is a need to understand how in-game data can be used to monitor patient changes in cognition. We aimed to derive a real-time measure of attention from AKL-T01 gameplay data and validate it against clinical outcomes. Trials of AKL-T01 included: STARS-ADHD-Adult (NCT05183919), a 6-week trial in adults 18 and older (n = 221; M age = 39.9; 70% female); STARS-ADHD-Adolescent (NCT04897074), a 4-week trial in adolescents ages 13-17 (n = 162; M age = 14.4; 41% female); and STARS-ADHD (NCT02674633), a 4-week trial in children ages 8-12 (n = 180; M age = 9.7; 31% female). A cognitive metric was derived from targeting response speed, targeting sensitivity (d-prime), and navigation skill level. Using multiple linear regression models, we analyzed relationships between cognitive metric change and changes in the Test of Variables of Attention (TOVA)-Attention Comparison Score (ACS), controlling for TOVA-ACS baseline, cognitive metric baseline, age, and sex. We explored associations with ADHD symptoms and quality of life. Increases in the cognitive metric significantly predicted increases in TOVA-ACS in the adult (β = 0.16, p < 0.001), adolescent (β = .09, p = 0.007), and pediatric (β = 0.06, p = 0.014) trials. Cognitive metric changes additionally related to self-reported quality of life in adults and clinician-rated ADHD symptoms in adolescents. Findings support the clinical validity of a real-time measure of attention derived from AKL-T01 patient-device interactions.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.