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Clinical Trials/NCT02225236
NCT02225236
Completed
Not Applicable

Improving Self-regulation & School Readiness in Preschoolers

Children's Hospital Medical Center, Cincinnati1 site in 1 country237 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Executive Dysfunction
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
237
Locations
1
Primary Endpoint
Behavior Rating Inventory of Executive Function-Preschool Version
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All children in preschool classrooms in selected schools.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Clinical Evaluation of Language Fundamentals - Preschool, Second Edition - Concepts and Following Directions(Outcome evaluation (~9 months after baseline evaluation))
  • NEPSY- Attention/Executive Function subtests(Outcome (~9 months after baseline evaluation))
  • Shape School(Outcome (~9 months after baseline evaluation))
  • Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Teacher Rating Scale(Outcome (~9 months after baseline evaluation))

Study Sites (1)

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