An Open-Label Study of a Wearable Device Targeting ADHD, Executive Function, and Academic Performance

This was an open-label pilot study to test the feasibility and preliminary efficacy of a wearable digital intervention developed to improve on-task behavior. This was an exploratory study to test for specificity of response on parent- and teacher-reported symptom outcomes in attention and hyperactive/impulsive symptoms, as well as domains of functional impairment, including school behavior and learning and executive function.

Participants included 38 children aged 8-12 years with a parent-reported past diagnosis of ADHD. Following baseline ratings from parents (N = 38) and teachers (N = 26), participants wore the device to school for four weeks. Parent and teacher ratings of ADHD symptoms, executive function, and functional impairment were repeated at the end of the four-week intervention period.

Statistically significant improvement was seen in the total scores for all parent and nearly all teacher outcomes, with moderate effect size improvements in attention, organization and planning, self-monitoring, school functioning, and teacher-reported academic performance.

Preliminary evidence from this open-label pilot study suggests that having a child interact with a wearable device to self-monitor attention is feasible. This exploratory, open-label pilot study found real-world improvement in functional domains, including academic performance. Future research will require a blinded, randomized, controlled trial using an appropriate sham comparator to confirm these findings.