Pilot Study of Digital Therapeutic NDTx-02 to Improve Executive Function in Children and Adolescents Ages 5 to 12 With ADHD or Autism Spectrum Disorder

What this Trial Is About

Researchers are evaluating the preliminary safety and effectiveness of a digital therapeutic device called NDTx-02 to help improve executive function in children and adolescents diagnosed with Attention-DeficitHyperactivity Disorder ADHD or Autism Spectrum Disorder ASD. This pilot clinical trial compares the effects of NDTx-02 combined with Treatment-As-Usual TAU to TAU alone using a randomized waitlist-control design. Participants are assigned to either an experimental group receiving NDTx-02 plus TAU for six weeks followed by TAU alone for six weeks, or a waitlist control group receiving TAU alone first and then NDTx-02 plus TAU for six weeks. The NDTx-02 intervention involves using a tablet with the software five times per week, totaling 30 sessions over six weeks. During the study, participants will undergo multiple assessments including behavior rating scales and cognitive tests like the K-BRIEF-2 and Stroop Color and Word Test. Researchers will monitor adherence to the device use schedule and evaluate changes in executive function, behavior, and clinical impressions. The primary comparison focuses on the first six weeks of intervention, and the total participation spans 12 weeks.

A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD