Development and Pilot Testing of a Novel Preschool Executive Function Curriculum
- Conditions
- Executive Dysfunction
- Registration Number
- NCT05135728
- Lead Sponsor
- Children's National Research Institute
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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
No longer enrolled at participating school or clinic site
• Insufficient English fluency or language skills to complete intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Feasibility of Intervention Through study completion, average of 20 weeks 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.
Acceptability of Intervention Through study completion, average of 20 weeks Acceptability will be measured via interventionist ratings on the Acceptability of Intervention Measure (AIM). Scores range from 4-20, where higher scores indicate higher acceptability.
Intervention Appropriateness Through study completion, average of 20 weeks Acceptability will be measured via interventionist ratings on the the Intervention Appropriateness Measure (IAM) at outcome.
Feasibility - Child Attendance Through study completion, average of 20 weeks Child attendance at groups will also be tracked.
- Secondary Outcome Measures
Name Time Method Interventionist Knowledge baseline, end of intervention - an average of 20 weeks between baseline and end of intervention Interventionist knowledge of executive functioning and intervention strategies will be assessed using a five-item multiple-choice survey.
Fidelity Observations twice throughout intervention period, average of 6 weeks between observations The Unstuck Treatment Implementation Measure will be used to assess interventionist fidelity. Standardized observations will be conducted, with ratings of fidelity on a Likert scale across several dimensions.
Trial Locations
- Locations (1)
Children's National Hospital
🇺🇸Silver Spring, Maryland, United States