Development and Pilot Testing of a Novel Preschool Executive Function Curriculum

NCT05135728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-08-21

No results posted yet for this 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).

Conditions

  • Executive Dysfunction

Interventions

BEHAVIORAL

Unstuck and On Target: Preschool

Unstuck \& On Target: Preschool (UOT:P) is a group-based curriculum for preschool and kindergarten students that targets executive function skills using CBT techniques. The UOT-P curriculum consists of 16 child small-group or classroom-wide lessons. Each lesson follows a clear structure in which the theme for the session is introduced in a storybook, supported with manipulatives and visuals. Children implement the skills introduced in the storybook through joing play activities that require them to flexibly adjusting their plans to work together. Children learn key vocabulary and active coping and problem-solving skills, with adult modeling and scaffolding, that enable them to build early executive functioning skills for self-regulation and classroom participation.

Sponsors & Collaborators

  • AppleTree Institute

    collaborator UNKNOWN
  • The Maddux School

    collaborator UNKNOWN
  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Lauren Kenworthy · Children's National Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135728 on ClinicalTrials.gov