Improving Self-regulation & School Readiness in Preschoolers

January 25, 2018 updated by: Children's Hospital Medical Center, Cincinnati
This project will develop and evaluate the initial effectiveness of an intervention training executive functioning, metacognition, and self-regulation in preschoolers attending certain high poverty Cincinnati preschools. Studies show that these skills are critical for school performance, and that children with better executive functioning have better long term outcomes. It is also important to intervene early when children are most likely to profit because their brains are rapidly developing. There are some promising programs targeting these skills in preschoolers, but few are available to teachers for implementation in the classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based program for the preschool classroom environment, and 2) to test the feasibility and initial impact of the adapted program on executive functioning and school readiness in schools with a high proportion of children from low income families.

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.

Detailed Description

We propose to translate a promising intervention, Executive-function Training for Attention and Metacognition (ETAM), originally developed for use in a clinic setting, to be delivered in the school setting, ultimately by teachers. Specifically, we propose to develop a curriculum that can be added to the classroom curriculum which will target the development of self-regulation and metacognition in preschoolers. Thus the purpose of the study is to 1) develop a teacher training program based on the principles we have found to be effective in a parent-based intervention and 2) test the feasibility and initial efficacy (i.e., reduced disruptive behaviors and increased school readiness) of the program in children from low income families. We will randomly assign 6 preschools to receive the teacher training component and 6 schools to serve as a control group (i.e., will not receive the intervention). We will conduct assessments on all preschoolers in the classroom prior to delivering the teacher training (i.e., beginning of the school year), provide the training to preschoolers in classrooms randomized to the active intervention group, and then conduct assessments at the end of the school year. Our primary aims are to assess the feasibility of a program designed to train teachers to incorporate the principles of the training program into the daily classroom environment, and to assess whether the program improves executive functioning and functional outcomes [i.e., Attention/Deficit-Hyperactivity Disorder (ADHD) symptoms, academic readiness, social competence], as compared to outcomes of children in the control schools. Although study personnel will be responsible for delivery of the intervention, preschool teachers will be closely involved in the process to provide ongoing feedback regarding the study intervention.

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.
237

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
    • Ohio
      • Cincinnati, Ohio, United States
        • Schools in the Archdiocese of Cincinnati to be determined

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 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

All children in preschool classrooms in selected schools.

Exclusion Criteria:

None

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: Prevention
  • Allocation: 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: Classroom Intervention
The intervention focuses on training executive functioning (e.g., working memory and inhibition) and metacognition (i.e., the ability to predict, check, monitor, coordinate and control cognitive operations) using play activities and structured language and reinforcement.
Behavioral: Classroom Intervention
No Intervention: No treatment control
No intervention

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
Behavior Rating Inventory of Executive Function-Preschool Version
Time Frame: Outcome assessment (~9 months after initial assessment)
Parents and teachers will complete this rating scale assessing executive function behaviors in the home and school environments, yielding T-scores on several subscales, including Inhibit, Shift, Emotional Control, Working Memory, Plan/Organize, Inhibitory Self-Control Index, Flexibility Index, Emergent Metacognition Index, and a Global Executive Composite. The scale has adequate reliability and validity as assessed in two- to five-year-olds
Outcome assessment (~9 months after initial assessment)

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
Clinical Evaluation of Language Fundamentals - Preschool, Second Edition - Concepts and Following Directions
Time Frame: Outcome evaluation (~9 months after baseline evaluation)
The Concepts and Following Directions subtest is a measure of auditory and visual attention. This subtest requires the child to interpret, recall, and execute oral commands of increasing length and complexity that contain concepts of functional language. A subscale score is computed for Concepts and Following Directions. Across ages (i.e., 3- to 7-year-olds), internal consistency ranged from .78 to .85 with an average of .82.
Outcome evaluation (~9 months after baseline evaluation)
NEPSY- Attention/Executive Function subtests
Time Frame: Outcome (~9 months after baseline evaluation)
The Visual Attention subtest is a measure of inhibition, scanning, vigilance, and impulsivity. This subtest is divided into two tasks (e.g., cats and faces, or bunnies and cats). The child is shown an exemplar at the top of the page (e.g., bunny) and is asked to circle all the bunnies amongst a number of other stimuli on the rest of the page as quickly as possible. The Statue subtest is a measure of motor persistence and inhibition. The child is asked to assume a pose and remain in it with their eyes closed for 75 seconds, ignoring distractors occurring at regular intervals. A subscale score is computed for each subtest. Reliabilities for the NEPSY at ages 3 through 7 are > .70.
Outcome (~9 months after baseline evaluation)
Shape School
Time Frame: Outcome (~9 months after baseline evaluation)
This assessment is a developmentally appropriate task developed for preschoolers assessing inhibition and switching. The child is presented with a colorful storybook of colorful circle and square figures and is administered 4 conditions (control, inhibit, switch, concurrent/both). In the control condition, the child names the colors of the figures as fast as possible. In the inhibit (response suppression) condition, the child only named the colors of the figures with happy faces and not frustrated faces. In the switch (attention control) condition, the child names the shapes of figures wearing hats. In the concurrent condition, the child is asked to name the figures (color or shape), who were both wearing hats and had happy faces. Cronbach's alpha coefficients for each condition exceeds 0.71.
Outcome (~9 months after baseline evaluation)
Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Teacher Rating Scale
Time Frame: Outcome (~9 months after baseline evaluation)
Teachers will be asked to complete the SKAMP to measure impairments in classroom functioning related to disruptive behaviors.
Outcome (~9 months after baseline evaluation)

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 Hospital Medical Center, Cincinnati

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.
Brady Education Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 1, 2015

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.
June 1, 2017

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.
December 1, 2017

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).
August 22, 2014

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.
August 22, 2014

First Posted (Estimate)

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.
August 26, 2014

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.
January 29, 2018

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.
January 25, 2018

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.
January 1, 2018

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.
  • FP00006613

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