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

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Attention-Deficit/Hyperactivity Disorder
• Intervention / Treatment: Device: NDTx-02 + TAU; Behavioral: TAU

Detailed Description

This pilot clinical trial aims to evaluate the preliminary safety and effectiveness of NDTx-02 in combination with Treatment-As-Usual (TAU) compared with TAU alone (waitlist control).

The study will employ a randomized waitlist-control design, in which participants will be assigned to either experimental group (immediate intervention) or waitlist control group (delayed intervention) with a 1:1 ratio.

• Experimental group (immediate intervention): NDTx-02 + TAU for the first 6 weeks (stage 1), followed by TAU only for the following 6 weeks (stage 2).
• Waitlist control group (delayed intervention): TAU only during the first 6 weeks (stage 1), followed by NDTx-02 + TAU for the following 6 weeks (stage 2).

Efficacy will be assessed using the K-BRIEF-2, K-VABS-II, K-ARS-5, KAT, WMT, C-TMT, Stroop Color and Word Test Children's Version, Digit Span test, CGI-S, and CGI-I.

The primary efficacy analysis will compare the experimental group and the waitlist control group during Stage 1 (weeks 0-6). The delayed intervention period (Stage 2) will be analyzed as secondary/exploratory.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SungJa Cho; Phone Number: +82-2-6959-9933; Email: sungja_cho@neudive.com

Study Locations

• South Korea
  • Daegu, South Korea, 42472
    • Recruiting
    • Daegu Catholic University Medical Center
    • Contact: Tae Young Choi, MD, PhD; Phone Number: +82-53-650-4184; Email: tyoungchoi@cu.ac.kr
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Yoo-Sook Joung, MD, PhD; Phone Number: +82-2-2258-1511; Email: yschoung@skku.edu
  • Seoul, South Korea, 06591
    • Recruiting
    • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Contact: JaeHyun Yoo, MD, PhD; Email: jay.yoo84@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group (immediate intervention); 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; 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.; Behavioral: TAU; TAU (Treatment-As-Usual): Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)-related treatment/rehabilitation/education.
Other: The waitlist control group (delayed intervention); TAU only during the first 6 weeks (stage 1), followed by NDTx-02 + TAU for the following 6 weeks (stage 2).	Behavioral: TAU; TAU (Treatment-As-Usual): Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)-related treatment/rehabilitation/education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
K-ARS-5 (Korean ADHD Rating Scale, 5th Edition)	The K-ARS-5 is a parent-rated scale for children aged 5-12, developed based on DSM-5 diagnostic criteria for ADHD. It contains 30 items that assess the frequency and severity of ADHD symptoms, including inattention and hyperactivity/impulsivity. Higher scores indicate greater ADHD symptom severity.	Baseline (V2,V4), Day 42 (V4,V6)
K-VABS-II (Korean Vineland Adaptive Behavior Scales-II)	The K-VABS-II is a clinician-administered tool for individuals from 0 to 99 years of age, assessing social and adaptive functioning across Communication, Daily Living Skills, Socialization, and Motor Skills, as well as a Maladaptive Behavior Index. It consists of 433 items. Standard scores range from 55 to 145, with higher scores reflecting better adaptive functioning.	Baseline (V2,V4), Day 42 (V4,V6)
KAT (Korean Attention Test System)	The KAT is an assessment tool for children aged 5-15 that systematically evaluates visual and auditory attention. It provides measures such as omission errors, commission errors, mean reaction time, and ADHD indices, and is designed to identify attention deficits and impulsivity.	Baseline (V2,V4), Day 42 (V4,V6)
WMT (Working Memory Test for Children)	The WMT is an assessment tool for children aged 5-15, designed to measure working memory capacity. It evaluates performance in forward and backward sequencing tasks, as well as longest span achieved. Scores provide insight into attention and working memory deficits, particularly for ADHD diagnosis.	Baseline (V2,V4), Day 42 (V4,V6)
C-TMT (Color Trail Making Test for Children)	The C-TMT is an assessment tool for children aged 5-15 that measures executive function and cognitive flexibility. It assesses completion times, sequencing errors, and interference indices. Poorer performance (longer completion time, more errors) indicates executive dysfunction, often associated with ADHD.	Baseline (V2,V4), Day 42 (V4,V6)
Stroop Color and Word Test - Children's Version	The Stroop Children's Test assesses frontal lobe function and inhibitory control in children aged 5-14. It evaluates words, color, color-word, and interference scores. It is used in the diagnosis of ADHD, tic disorders, learning disabilities, and autism spectrum disorder, as well as in assessing neuropsychological deficits.	Baseline (V2,V4), Day 42 (V4,V6)
Digit Span Test	The Digit Span subtest of the K-WISC-V assesses auditory attention and working memory. It includes Digit Span Forward, Digit Span Backward, and Digit Span Sequencing, as well as the longest span achieved in each category. Higher scores indicate better memory capacity and attentional control.	Baseline (V2,V4), Day 42 (V4,V6)
CGI-S (Clinical Global Impression-Severity)	The CGI-S is a clinician-rated scale assessing overall illness severity on a 7-point scale (1 = normal, 7 = extremely severe). Clinicians rate current severity relative to past patients with the same diagnosis, providing a standardized severity assessment.	Baseline (V2,V4), Day 42 (V4,V6)
CGI-I (Clinical Global Impression-Improvement)	The CGI-I is a clinician-rated scale assessing overall improvement or worsening of the patient's condition compared to baseline. It is rated on a 7-point scale (1 = very much improved, 7 = very much worse). Lower scores indicate greater clinical improvement.	Day 42 (V4,V6)

Collaborators and Investigators

• Sponsor: Neudive Inc.
• Investigators: Principal Investigator: Yoo-Sook Joung, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Children; Intervention; Autism Spectrum Disorder; Attention-Deficit/Hyperactivity Disorder; Executive function; Cognitive Behavior Therapy; Digital therapeutics; Self-management skills
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Attention Deficit and Disruptive Behavior Disorders; Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: ND-05; DIP2024BrainAI (Other Grant/Funding Number: Daegu Digital Innovation Promotion Agency (DIP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No