Development and Pilot Testing of a Novel Preschool Executive Function Curriculum

August 19, 2024 updated by: Allison Ratto, Children's National Research Institute

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Silver Spring, Maryland, United States, 20901
        • Children's National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Unstuck and On Target-Preschool
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
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.
Active Comparator: Waitlist Control
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention
Time Frame: 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.
Through study completion, average of 20 weeks
Feasibility - Child Attendance
Time Frame: Through study completion, average of 20 weeks
Child attendance at groups will also be tracked.
Through study completion, average of 20 weeks
Acceptability of Intervention
Time Frame: 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.
Through study completion, average of 20 weeks
Intervention Appropriateness
Time Frame: Through study completion, average of 20 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fidelity Observations
Time Frame: 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.
twice throughout intervention period, average of 6 weeks between observations
Interventionist Knowledge
Time Frame: 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.
baseline, end of intervention - an average of 20 weeks between baseline and end of intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child Behavior Rating Scale (CBRS)
Time Frame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
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
Head-Toes-Knees-Shoulders Revised (HTKS-R)
Time Frame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
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
Differential Ability Scales-II (DAS-II): Pattern Construction
Time Frame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
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
Classroom Observations
Time Frame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
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
Behavior Rating Inventory of Executive Functioning-Preschool (BRIEF-P): Selected subscales
Time Frame: baseline, end of intervention - an average of 20 weeks between baseline and end of intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's National Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AppleTree Institute
The Maddux School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lauren Kenworthy, Children's National

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00014103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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