Attention-Deficit/Hyperactivity DisorderNCT07242625
A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
A study testing NDTx-02 + TAU and TAU in people with Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder, run by Neudive Inc. at 3 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder
- What is being tested?
- NDTx-02 + TAU and TAU
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 16 Oct 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Daegu Catholic University Medical Center
Daegu, 42472
Tae Young Choi, MD, PhD, +82-53-650-4184, tyoungchoi@cu.ac.kr
- Recruiting
Samsung Medical Center
Seoul, 06351
Yoo-Sook Joung, MD, PhD, +82-2-2258-1511, yschoung@skku.edu
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
JaeHyun Yoo, MD, PhD, jay.yoo84@gmail.com
About this study
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)
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).
Read the 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.
- Being tested
- NDTx-02 + TAU, TAU
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder, Digital therapeutics, Executive function, Children, Adolescents, Self-management skills, Cognitive Behavior Therapy, Intervention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NDTx-02 + TAUDevice
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.
TAUBehavioural
TAU (Treatment-As-Usual): Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)-related treatment/rehabilitation/education.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (V2,V4), Day 42 (V4,V6)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 42 (V4,V6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start16 Oct 2025
- Primary completionApr 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neudive Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoo-Sook Joung, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242625
- Sponsor's protocol ID
- ND-05
- Other IDs
- DIP2024BrainAI
- Status last verified
- Nov 2025
- First submitted
- 29 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07242625
- Acronym / sponsor ID
- ND-05
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder, Digital therapeutics, Executive function, Children, Adolescents, Self-management skills, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Neudive Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group (immediate intervention) | Experimental | Device: NDTx-02 + TAU, Behavioral: TAUNDTx-02 + TAU for the first 6 weeks (stage 1), followed by TAU only for the following 6 weeks (stage 2). |
| The waitlist control group (delayed intervention) | Other | Behavioral: TAUTAU only during the first 6 weeks (stage 1), followed by NDTx-02 + TAU for the following 6 weeks (stage 2). |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NDTx-02 + TAUNDTx-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. | Device | The experimental group (immediate intervention) |
| TAUTAU (Treatment-As-Usual): Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD)-related treatment/rehabilitation/education. | Behavioural | The experimental group (immediate intervention), The waitlist control group (delayed intervention) |
Primary outcome
K-BRIEF-2 (Behavior Rating Inventory of Executive Function, Second Edition)
Time frame: Baseline (V2,V4), Day 42 (V4,V6)
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.
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yoo-Sook Joung, MD, PhD principal investigator
Samsung Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NDTx-02 + TAU and TAU in people with Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder, run by Neudive Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SungJa Cho (+82-2-6959-9933, sungja_cho@neudive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
K-BRIEF-2 (Behavior Rating Inventory of Executive Function, Second Edition) (time frame: Baseline (V2,V4), Day 42 (V4,V6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.