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NCT05135728 · ClinicalTrials.gov registry record · NA
Development and Pilot Testing of a Novel Preschool Executive Function Curriculum
A NA study, sponsored by Children's National Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT05135728: Completed NA study, sponsored by Children's National Research Institute.
NCT05135728 is a NA study that has completed, run by Children's National Research Institute. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05135728, a NA study, has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
Executive function (EF) skills are a set of essential cognitive abilities that enable individuals to demonstrate their knowledge and talents, effectively complete tasks and navigate social interactions through flexible regulation of their thinking, behavior and emotions. EF is strongly linked to academic readiness and long-term educational outcomes. Children's EF is impacted by poverty-related experiences and is also impaired in the increasing number of children with developmental and emotional disabilities. Interventions targeting EF skills hold particular promise for improving children's educational trajectories by leveraging brain plasticity in the preschool period. We will directly target EF skills in preschoolers with poor EF. This project will address a key source of the achievement gap by meeting the needs of children at the highest risk, those who: 1) show early signs of EF impairment; 2) live in low-income communities and 3) are at risk for developmental and emotional disabilities (DD/ED). The intervention is a downward extension of Unstuck and On Target for elementary school (UOT; Cannon, Kenworthy, Alexander, Werner, \& Anthony, 2018), an EF intervention shown to be effective at increasing children's learning behaviors, as delivered by school staff. The research team will partner with key stakeholders to revise and iteratively refine UOT-P through a development trial, utilizing participant, teacher and parent feedback. The results of this trial will be leveraged to enable the team to apply for future federal funding for a randomized comparative effectiveness trial (NIH, Institute of Educational Sciences, Patient-Centered Outcomes Research Institute).
Primary Outcome
Interventionist ratings of feasibility will serve as the primary outcome measure. Interventionists will rate overall intervention feasibility using the Feasibility of Intervention Measure (FIM) at outcome. Scores range 4-20, where higher scores indicate higher feasibility.
Interventions
- BEHAVIORAL Unstuck and On Target: Preschool
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2024-08-01 |
| Phase | NA |
What the finished NCT05135728 record still lists
NCT05135728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Unstuck and On Target: Preschool is the first listed.
NCT05135728 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05135728 about?
NCT05135728 is a clinical study titled "Development and Pilot Testing of a Novel Preschool Executive Function Curriculum". Executive function (EF) skills are a set of essential cognitive abilities that enable individuals to demonstrate their knowledge and talents, effectively complete tasks and navigate social interactions through flexible regulation of their thinking, behavior and emotions. EF is strongly linked to aca...
What is the current status of trial NCT05135728?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2021-11-15. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT05135728?
The interventions under investigation include: Unstuck and On Target: Preschool (BEHAVIORAL).
Who is sponsoring clinical trial NCT05135728?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05135728's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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