Development and Pilot Testing of a Novel Preschool Executive Function Curriculum

Executive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05135728
• Other study ID #: Pro00014103
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: July 2023
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 55
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Executive Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	Children's National Hospital	Silver Spring	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Children's National Research Institute	AppleTree Institute, The Maddux School

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Behavior Rating Scale (CBRS)	This is a development trial, and thus primary outcomes assess feasibility and acceptability. However, preliminary investigation of child-level outcomes will also be undertaken. Classroom teachers will respond complete the CBRS, which uses a Likert scale to rate children's classroom behaviors for engagement with academic tasks, adults, and peers.	baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
Other	Head-Toes-Knees-Shoulders Revised (HTKS-R)	This is a development trial, and thus primary outcomes assess feasibility and acceptability. However, preliminary investigation of child-level outcomes will also be undertaken. Trained assessors will administer the HTKS-R to child participants, which assesses self-regulation and emerging executive functioning. The HTKS-R is a short (5-8 minutes) behavioral task that assess children's working memory and impulse control through a short game in which children are introduced to paired body parts and instructed to touch the opposite body part of the one named.	baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
Other	Differential Ability Scales-II (DAS-II): Pattern Construction	This is a development trial, and thus primary outcomes assess feasibility and acceptability. However, preliminary investigation of child-level outcomes will also be undertaken. The Pattern Construction subtest of the DAS-II will be administered to child participants. It requires children to replicate a visual design with blocks under timed conditions. Performance on this task is correlated with executive functioning abilities.	baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
Other	Classroom Observations	This is a development trial, and thus primary outcomes assess feasibility and acceptability. However, preliminary investigation of child-level outcomes will also be undertaken. Trained evaluators will observe child participants' behavior over the course of 10-15 minutes in the classroom. Behaviors directly targeted in the intervention will be coded using a yes/no rating to indicate the presence or absence of a problem behavior during the observation.	baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
Other	Behavior Rating Inventory of Executive Functioning-Preschool (BRIEF-P): Selected subscales	This is a development trial, and thus primary outcomes assess feasibility and acceptability. However, preliminary investigation of child-level outcomes will also be undertaken. Parent report of child participant behavior on the Shift and Emotional Control subscales of the BRIEF-P (an age-normed parent report measure of daily executive functioning problems in preschoolers) will be used to assess change in daily executive functioning skills.	baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
Primary	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
Primary	Feasibility - Child Attendance	Child attendance at groups will also be tracked.	Through study completion, average of 20 weeks
Primary	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
Primary	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	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
Secondary	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