An interventional study of NDTx-02 + TAU and TAU in Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder, sponsored by Neudive Inc.. Recruiting at 3 sites in South Korea. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Neudive Inc. · Not applicable, Interventional, and Treatment
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).
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.
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's planned enrollment of 48 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Neudive Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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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
Exclusion Criteria:
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
TAU only during the first 6 weeks (stage 1), followed by NDTx-02 + TAU for the following 6 weeks (stage 2).
Behavioral: 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.
TAU (Treatment-As-Usual): Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)-related treatment/rehabilitation/education.
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.
Time frame: Baseline (V2,V4), Day 42 (V4,V6)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 42 (V4,V6)
Plan to share: No
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