A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD
NCT07242625, Not applicable, Recruiting, Neudive Inc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Pilot Study on Efficacy of Digital Therapeutic NDTx-02 for Executive Function in Children and Adolescents With ADHD or ASD | ClinicalTrials.gov |
| NCT number | NCT07242625 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Neudive Inc. | ClinicalTrials.gov |
| Conditions | Attention-Deficit/Hyperactivity Disorder, Autism Spectrum Disorder | ClinicalTrials.gov |
| Interventions | NDTx-02 + TAU, TAU | ClinicalTrials.gov |
| First posted | 2025-11-21 | ClinicalTrials.gov |
| Last updated | 2025-11-21 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | K-BRIEF-2 (Behavior Rating Inventory of Executive Function, Second Edition) | 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. | ClinicalTrials.gov |
| Secondary | K-ARS-5 (Korean ADHD Rating Scale, 5th Edition) | Baseline (V2,V4), Day 42 (V4,V6) | 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. | ClinicalTrials.gov |
| Secondary | K-VABS-II (Korean Vineland Adaptive Behavior Scales-II) | Baseline (V2,V4), Day 42 (V4,V6) | 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. | ClinicalTrials.gov |
| Secondary | KAT (Korean Attention Test System) | Baseline (V2,V4), Day 42 (V4,V6) | 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. | ClinicalTrials.gov |
| Secondary | WMT (Working Memory Test for Children) | Baseline (V2,V4), Day 42 (V4,V6) | 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. | ClinicalTrials.gov |
| Secondary | C-TMT (Color Trail Making Test for Children) | Baseline (V2,V4), Day 42 (V4,V6) | 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. | ClinicalTrials.gov |
| Secondary | Stroop Color and Word Test - Children's Version | Baseline (V2,V4), Day 42 (V4,V6) | 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. | ClinicalTrials.gov |
| Secondary | Digit Span Test | Baseline (V2,V4), Day 42 (V4,V6) | 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. | ClinicalTrials.gov |
| Secondary | CGI-S (Clinical Global Impression-Severity) | Baseline (V2,V4), Day 42 (V4,V6) | 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. | ClinicalTrials.gov |
| Secondary | CGI-I (Clinical Global Impression-Improvement) | Day 42 (V4,V6) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)