Improving Self-regulation & School Readiness in Preschoolers

Executive Dysfunction Clinical Trial

Official title:

Improving Self-regulation & School Readiness in Preschoolers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225236
• Other study ID #: FP00006613
• Status: Completed
• Phase: N/A
• First received: August 22, 2014
• Last updated: January 25, 2018
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

Inclusion Criteria:

All children in preschool classrooms in selected schools.

Exclusion Criteria:

Related Conditions & MeSH terms

• Executive Dysfunction

Intervention

Behavioral:
• Classroom Intervention

Locations

Country	Name	City	State
United States	Schools in the Archdiocese of Cincinnati to be determined	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Brady Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior Rating Inventory of Executive Function-Preschool Version	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	Clinical Evaluation of Language Fundamentals - Preschool, Second Edition - Concepts and Following Directions	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)
Secondary	NEPSY- Attention/Executive Function subtests	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)
Secondary	Shape School	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)
Secondary	Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Teacher Rating Scale	Teachers will be asked to complete the SKAMP to measure impairments in classroom functioning related to disruptive behaviors.	Outcome (~9 months after baseline evaluation)