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NCT04108273 · ClinicalTrials.gov registry record · NA
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children
A NA study of Attention Deficit Hyperactivity Disorder and ADHD, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT04108273: Completed NA study of Attention Deficit Hyperactivity Disorder and ADHD, sponsored by NYU Langone Health.
NCT04108273 is a NA study of Attention Deficit Hyperactivity Disorder and ADHD that has completed, run by NYU Langone Health. The registered enrollment target is 59 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04108273, a NA study of Attention Deficit Hyperactivity Disorder and ADHD, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
Organizational, time management and planning (OTMP) skills deficits are impairing features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD), which compromise school performance and family relations. The manualized Organizational Skills Training program (OST) was designed to target children's specific OTMP deficits. However, the brain mechanisms of treatment-induced changes remain unknown. The current study combines a training intervention (OST) with non-invasive MRI imaging in a pre-/post-design in a randomized two-arm (treatment vs. waitlist) trial to address this question.
Primary Outcome
The iFC between the two regions was measured at both baseline and follow-up by calculating the Fisher Z-transformed correlation between the average time-series of all voxels within each region of interest (positive values indicate increased iFC between the two regions, while negative values indicate decreased iFC). Then, to determine the change in iFC due to the intervention/waitlist period, the iFC between both regions at baseline was subtracted from the iFC between both regions at follow-up. T
Conditions Studied
Interventions
- BEHAVIORAL Organizational Skills Training
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2023-08-01 |
| Phase | NA |
What the finished NCT04108273 record still lists
NCT04108273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (73% lower).
The record links to 3 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention - of which Organizational Skills Training is the first listed.
NCT04108273 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04108273 about?
NCT04108273 is a clinical study titled "Brain Plasticity Underlying Acquisition of New Organizational Skills in Children". Organizational, time management and planning (OTMP) skills deficits are impairing features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD), which compromise school performance and family relations. The manualized Organizational Skills Training program (OST) was desi...
What is the current status of trial NCT04108273?
This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2019-10-01. Estimated completion is 2023-08-01.
What conditions does trial NCT04108273 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, ADHD, Neurodevelopmental Disorders.
What interventions are being tested in trial NCT04108273?
The interventions under investigation include: Organizational Skills Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04108273?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04108273 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04108273's enrollment target sits among peer trials
59 59th of 102 higher than 44 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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