Development and Pilot Testing of a Novel Preschool Executive Function Curriculum

Study Overview
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Brief Summary
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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).

Official Title
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Development and Pilot Testing of a Novel Preschool Executive Function Curriculum Development of an Executive Function Intervention for Adolescents With Autism Spectrum Disorders

Conditions
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Executive Dysfunction

Intervention / Treatment
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* Behavioral: Unstuck and On Target: Preschool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: No longer enrolled at participating school or clinic site • Insufficient English fluency or language skills to complete intervention

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unstuck and On Target-Preschool<br>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<br>* 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.<br>|
| Active Comparator: Waitlist Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fidelity 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. | twice throughout intervention period, average of 6 weeks between observations | 
| Interventionist Knowledge | Interventionist knowledge of executive functioning and intervention strategies will be assessed using a five-item multiple-choice survey. | baseline, end of intervention - an average of 20 weeks between baseline and end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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young children, intervention, preschool