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Recruiting NCT07242625

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

No phase Interventional Attention-Deficit/Hyperactivity Disorder Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NDTx-02 + TAU, TAU.
Who it may be relevant to
Registry conditions: Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder. Basic parameters: 5 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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).

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.

Interventions

  • 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.

Primary outcome measures

  • K-BRIEF-2 (Behavior Rating Inventory of Executive Function, Second Edition) [Time frame: Baseline (V2,V4), Day 42 (V4,V6)]
Secondary outcome measures (9)
  • K-ARS-5 (Korean ADHD Rating Scale, 5th Edition) [Time frame: Baseline (V2,V4), Day 42 (V4,V6)]
  • K-VABS-II (Korean Vineland Adaptive Behavior Scales-II) [Time frame: Baseline (V2,V4), Day 42 (V4,V6)]
  • KAT (Korean Attention Test System) [Time frame: Baseline (V2,V4), Day 42 (V4,V6)]
  • WMT (Working Memory Test for Children) [Time frame: Baseline (V2,V4), Day 42 (V4,V6)]
  • C-TMT (Color Trail Making Test for Children) [Time frame: Baseline (V2,V4), Day 42 (V4,V6)]
  • Stroop Color and Word Test - Children's Version [Time frame: Baseline (V2,V4), Day 42 (V4,V6)]
  • Digit Span Test [Time frame: Baseline (V2,V4), Day 42 (V4,V6)]
  • CGI-S (Clinical Global Impression-Severity) [Time frame: Baseline (V2,V4), Day 42 (V4,V6)]
  • CGI-I (Clinical Global Impression-Improvement) [Time frame: Day 42 (V4,V6)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

South Korea · 3 centers
  • Daegu Catholic University Medical Center — Daegu
  • Samsung Medical Center — Seoul
  • The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul

Identifiers

NCT: NCT07242625 · ND-05 · DIP2024BrainAI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗