Development and Pilot Testing of a Novel Preschool Executive Function Curriculum

NCT05135728 | Completed

• 1 other identifier: Pro00014103
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Executive Dysfunction

Keywords

young children; intervention; preschool

Outcome Measures

Primary Outcomes (4)

• Feasibility of Intervention

  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.

  Through study completion, average of 20 weeks

• Feasibility - Child Attendance

  Child attendance at groups will also be tracked.

  Through study completion, average of 20 weeks

• Acceptability of Intervention

  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.

  Through study completion, average of 20 weeks

• Intervention Appropriateness

  Acceptability will be measured via interventionist ratings on the the Intervention Appropriateness Measure (IAM) at outcome.

  Through study completion, average of 20 weeks

Secondary Outcomes (2)

• Fidelity Observations

  twice throughout intervention period, average of 6 weeks between observations

• Interventionist Knowledge

  baseline, end of intervention - an average of 20 weeks between baseline and end of intervention

Other Outcomes (5)

• Child Behavior Rating Scale (CBRS)

  baseline, end of intervention - an average of 20 weeks between baseline and end of intervention

• Head-Toes-Knees-Shoulders Revised (HTKS-R)

  baseline, end of intervention - an average of 20 weeks between baseline and end of intervention

• Differential Ability Scales-II (DAS-II): Pattern Construction

  baseline, end of intervention - an average of 20 weeks between baseline and end of intervention

Study Arms (2)

Unstuck and On Target-Preschool

EXPERIMENTAL

UOT-P is based on the foundational principles of UOT for improving EF as well as evidence-based teaching methods (e.g., positive behavior supports, visual aids). Through this program, children, teachers and parents develop a shared self-regulatory vocabulary that enables children to improve EF at home and school through adult modeling and gradual scaffolding. The self-regulatory vocabulary (e.g., Flexible, Make a New Plan, Unstuck) becomes a "contagious" common language. We hypothesize this is the mechanism of change by which children will show improved EF skills, leading to increased academic readiness, improved social competence and reduced externalizing behaviors.

Behavioral: Unstuck and On Target: Preschool

Waitlist Control

ACTIVE COMPARATOR

Children at clinic sites beginning in Year 4 will be placed in Arm 2, in which a waitlist control model will be used. Assessment of participants on outcome measures will occur at pre-intervention, followed by a 16-week waitlist period, again at baseline, followed by a 16-week intervention, and then finally at endpoint. All participants in Arm 2 will receive UOT-P as their intervention (see Experimental Arm).

Behavioral: Unstuck and On Target: Preschool

Interventions

Unstuck and On Target: Preschool BEHAVIORAL

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.

Unstuck and On Target-Preschool; Waitlist Control

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• No longer enrolled at participating school or clinic site
• Insufficient English fluency or language skills to complete intervention

Sponsors & Collaborators

• Children's National Research Institute: lead
• AppleTree Institute: collaborator
• The Maddux School: collaborator

Study Sites (1)

Children's National Hospital

Silver Spring, Maryland, 20901, United States

Location

Study Officials

• Lauren Kenworthy

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist, Center for Autism Spectrum Disorders

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 26, 2021
• Study Start: November 15, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)