NCT05135728Completed
Development and Pilot Testing of a Novel Preschool Executive Function Curriculum
Development and Pilot Testing of a Novel Preschool Executive Function Curriculum Development of an Executive Function Intervention for Adolescents With Autism Spectrum Disorders
Source: ClinicalTrials.gov · Last updated 21 Aug 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 6 Oct 2021
- Start date
- 15 Nov 2021
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- Children's National Research Institute
- Diseases
- Autism
- NCT number
- NCT05135728
What you commit to
- Study type: Interventional
- Participants enrolled: 63
- From 15 Nov 2021 to the primary completion date, 1 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- No longer enrolled at participating school or clinic site
- Insufficient English fluency or language skills to complete intervention
Who the study is looking for
- Enrolled as a student at a participating school site OR as a patient at a participating clinic site
- Chronological age between 3-6 years at enrollment
- English as a primary language
- Roughly age-appropriate core language skills as determined by referring school staff or provider
- Identified by school staff or provider as having problems with flexibility
Age in the registry: 3 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Hospital Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.