A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorNeudive Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
NDTx-02 + TAU
DeviceNDTx-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
BehavioralTAU (Treatment-As-Usual): Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)-related treatment/rehabilitation/education.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: The experimental group (immediate intervention)Experimental treatment 2 interventions
Group B: The waitlist control group (delayed intervention)Other 1 intervention
Trial outcomes
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.
Time frame
Baseline (V2,V4), Day 42 (V4,V6)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov