A Multi-center, Prospective, Compared, Randomized, Evaluator-blinded, Pilot Study to Evaluate the Effectiveness of Digital Therapeutics 'NDTx-02' on Executive Function in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)

NCT07242625 NA RECRUITING

The purpose of this study is to explore the preliminary safety and effectiveness of the digital therapeutic device 'NDTx-02' in supporting improvements of executive function in children and adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD).

Details

Lead sponsor	Neudive Inc.
Phase	NA
Status	RECRUITING
Enrolment	48
Start date	2025-10-16
Completion	2026-08

Conditions

• Attention-Deficit/Hyperactivity Disorder
• Autism Spectrum Disorder

Interventions

• NDTx-02 + TAU
• TAU

Primary outcomes

• K-BRIEF-2 (Behavior Rating Inventory of Executive Function, Second Edition) — Baseline (V2,V4), Day 42 (V4,V6)
  The K-BRIEF-2 consists of 63 items rated on a 3-point scale (Never, Sometimes, Often). The K-BRIEF-2 comprises 9 scales (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task-Monitor, Organization of Materials) organized under 3 index scores (Behavior Regulation, Emotion Regulation, Cognitive Regulation). The 9 scales collectively yield the Global Executive Composite (GEC), which reflects overall executive functioning. Higher T scores indicate greater executive function difficulties.

Countries

South Korea