Tablet-based NDTx-02 program to improve executive function in children with ADHD or autism
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)
Run by Neudive Inc. · NCT07242625 · Data updated 2026-11-12
This pilot test tries a tablet-based digital therapeutic called NDTx-02 alongside usual care to see if it helps executive function in children aged 5–12 with ADHD or autism.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 12 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Neudive Inc. Industry-sponsored |
| Locations | 3 sites (Daegu and 2 other locations) |
| Status | Recruiting |
| Started | October 16, 2025 |
| Main results expected | April 2026 |
| Study ends | August 2026 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07242625 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 5–12 diagnosed with ADHD or ASD by a psychiatrist, with FSIQ ≥65, able to use a tablet (alone or with guardian help), and able to commit to the 6-week, 30-session schedule while keeping existing treatments stable.
✕Probably not a fit
Children with FSIQ below 65, those unable to use a tablet or complete the required sessions, or those who need to change therapies during the study are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, waitlist-controlled pilot comparing NDTx-02 plus treatment-as-usual (TAU) versus TAU alone, with participants assigned 1:1 to immediate or delayed intervention. The immediate group uses NDTx-02 with TAU for 6 weeks then continues TAU alone, while the waitlist group receives TAU for 6 weeks followed by NDTx-02 plus TAU in the second 6-week stage. Primary analyses compare outcomes between groups in the first 6-week stage, with secondary/exploratory analyses of the delayed period. Outcomes include parent- and clinician-rated executive function and adaptive behavior scales plus cognitive tests such as BRIEF-2, VABS-II, ARS-5, Stroop, Trail Making, Digit Span, and clinical global impressions.
Why it matters
Potential benefit: If successful, the device could improve attention, working memory, and planning skills to help daily functioning and school performance.
How similar studies have gone: Some prior digital cognitive-training programs have shown modest, mixed benefits for attention and working memory, but device-specific evidence for NDTx-02 is novel and limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Daegu Catholic University Medical Center
Daegu, South Korea Recruiting -
Samsung Medical Center
Seoul, South Korea Recruiting -
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Yoo-Sook Joung, MD, PhD — Samsung Medical Center
- Study coordinator: SungJa Cho
- Email: sungja_cho@neudive.com
- Phone: +82-2-6959-9933
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.