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

NCT07242625 | Recruiting

• 2 other identifiers: ND-05DIP2024BrainAI
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Attention-Deficit/Hyperactivity Disorder; Autism Spectrum Disorder

Keywords

Attention-Deficit/Hyperactivity Disorder; Autism Spectrum Disorder; Digital therapeutics; Executive function; Children; Adolescents; Self-management skills; Cognitive Behavior Therapy; Intervention

Outcome Measures

Primary Outcomes (1)

• K-BRIEF-2 (Behavior Rating Inventory of Executive Function, Second Edition)

  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.

  Baseline (V2,V4), Day 42 (V4,V6)

Secondary Outcomes (9)

• K-ARS-5 (Korean ADHD Rating Scale, 5th Edition)

  Baseline (V2,V4), Day 42 (V4,V6)

• K-VABS-II (Korean Vineland Adaptive Behavior Scales-II)

  Baseline (V2,V4), Day 42 (V4,V6)

• KAT (Korean Attention Test System)

  Baseline (V2,V4), Day 42 (V4,V6)

• WMT (Working Memory Test for Children)

  Baseline (V2,V4), Day 42 (V4,V6)

• C-TMT (Color Trail Making Test for Children)

  Baseline (V2,V4), Day 42 (V4,V6)

Study Arms (2)

The experimental group (immediate intervention)

EXPERIMENTAL

NDTx-02 + TAU for the first 6 weeks (stage 1), followed by TAU only for the following 6 weeks (stage 2).

Device: NDTx-02 + TAU; Behavioral: TAU

The waitlist control group (delayed intervention)

OTHER

TAU only during the first 6 weeks (stage 1), followed by NDTx-02 + TAU for the following 6 weeks (stage 2).

Behavioral: TAU

Interventions

NDTx-02 + TAU DEVICE

NDTx-02 intervention: Participants will be provided with a tablet pre-installed with NDTx-02 and instructed to use the device five times per week for six weeks, for a total of 30 sessions.

The experimental group (immediate intervention)

TAU BEHAVIORAL

TAU (Treatment-As-Usual): Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)-related treatment/rehabilitation/education.

The experimental group (immediate intervention); The waitlist control group (delayed intervention)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children and adolescents aged 5 to 12 years at the time of screening
• Diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)\* by a psychiatrist according to DSM-5 diagnostic criteria
• \*For ASD, diagnosis can be supported by the Autism Diagnostic Interview-Revised (ADI-R) or the Autism Diagnostic Observation Schedule (ADOS), either version 1 or 2
• Full-Scale Intelligence Quotient (FSIQ) of 65 or higher
• Able to use the 'NDTx-02' installed on a tablet, alone or with the assistance of a guardian
• Able to comply with the recommended application schedule for the investigational device (6 weeks, 30 sessions, 5 times per week)
• Agree not to add or change any treatment/education/rehabilitation programs or medications, including Applied Behavior Analysis (ABA) or cognitive therapy, during the study period (continuation of pre-existing TAU \[Treatment-As-Usual\] is allowed)
• Participant and parent (or legal guardian) voluntarily decide to join the trial and provide written informed consent
• Participants willing to comply with the clinical trial procedures

You may not qualify if:

• A risk of clinically significant behavioral problems, emotion regulation problems, psychotic symptoms, self-harm, or other harm at a level that affects the treatment process
• Severe acute/chronic medical or mental illness
• Serious trauma or surgery performed within 4 weeks before the screening date
• Participants with other disabilities such as severe neurological diseases (e.g. brain lesions, mental disorders, etc.)
• Participants who are currently participating in another clinical trial or have participated in another clinical trial within 30 days before the screening date
• Change in the dosage or regimen of medications that may significantly affect cognitive function within 4 weeks prior to the baseline visit
• Change in participation in treatment/education/rehabilitation programs that may significantly affect cognitive function within 4 weeks prior to the baseline visit
• Participation in a clinical trial of, or prior experience using, cognitive improvement or daily living improvement software within 12 weeks prior to the baseline visit
• In other cases where the investigator determines that participation in the clinical trial is inappropriate due to ethical reasons or the possibility of influencing the results of the clinical trial

Sponsors & Collaborators

• Neudive Inc.: lead

Study Sites (3)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Study Officials

• Yoo-Sook Joung, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SungJa Cho

CONTACT

+82-2-6959-9933; sungja_cho@neudive.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 21, 2025
• Study Start: October 16, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)