Actively Recruiting
A Pilot Study to Evaluate the Effectiveness of Digital Therapeutic NDTx-02 on Executive Function in Children and Adolescents With ADHD or Autism Spectrum Disorder
Led by Neudive Inc. · Updated on 2025-11-21
48
Participants Needed
3
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary safety and effectiveness of a digital therapeutic device called NDTx-02 to help improve executive function in children and adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD). This pilot clinical trial compares the effects of NDTx-02 combined with Treatment-As-Usual (TAU) to TAU alone using a randomized waitlist-control design. Participants are assigned to either an experimental group receiving NDTx-02 plus TAU for six weeks followed by TAU alone for six weeks, or a waitlist control group receiving TAU alone first and then NDTx-02 plus TAU for six weeks. The NDTx-02 intervention involves using a tablet with the software five times per week, totaling 30 sessions over six weeks. During the study, participants will undergo multiple assessments including behavior rating scales and cognitive tests like the K-BRIEF-2 and Stroop Color and Word Test. Researchers will monitor adherence to the device use schedule and evaluate changes in executive function, behavior, and clinical impressions. The primary comparison focuses on the first six weeks of intervention, and the total participation spans 12 weeks.
CONDITIONS
Brief Title
A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 5 to 12 years at screening
- Diagnosed with ADHD or Autism Spectrum Disorder by a psychiatrist using DSM-5 criteria
- For ASD, diagnosis supported by ADI-R or ADOS assessments
- Full-Scale Intelligence Quotient of 65 or higher
- Able to use the NDTx-02 tablet software alone or with help
- Able to follow the device use schedule (5 times per week for 6 weeks, total 30 sessions)
- Agree not to change other treatments or therapies during the study (continuing existing treatments allowed)
- Participant and parent/legal guardian provide written informed consent
- Willing to comply with all clinical trial procedures
You will not qualify if you...
- Significant behavioral or emotion regulation problems that interfere with treatment
- Severe acute or chronic medical or mental illness
- Recent serious trauma or surgery within 4 weeks before screening
- Other disabilities such as severe neurological diseases
- Currently enrolled or recently participated in another clinical trial within 30 days
- Recent changes in medications affecting cognitive function within 4 weeks before baseline
- Recent changes in treatment or therapy programs affecting cognitive function within 4 weeks before baseline
- Prior use or participation in cognitive improvement software trials within 12 weeks before baseline
- Investigator determines participation is inappropriate for ethical or result integrity reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants use the NDTx-02 digital therapeutic on a tablet five times per week for six weeks, combined with their usual ADHD or ASD treatment during this period. Participants in the waitlist control group receive usual treatment without NDTx-02 during these six weeks.
Weekly visits for up to 6 weeks
Duration - 6 weeks
Participants who were in the waitlist control group during the first stage begin using NDTx-02 combined with their usual treatment for six weeks. Participants who used NDTx-02 in the first stage continue with usual treatment only during this period.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 3 locations
1
Daegu Catholic University Medical Center
Daegu, South Korea, 42472
Actively Recruiting
2
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
3
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
Research Team
S
SungJa Cho
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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