Improving Self-regulation & School Readiness in Preschoolers

NCT ID: NCT02225236

Last Updated: 2018-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Executive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Classroom Intervention

Intervention Type: BEHAVIORAL

No treatment control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Classroom Intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

All children in preschool classrooms in selected schools.

Exclusion Criteria

None

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brady Education Foundation

UNKNOWN

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leanne Tamm, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Schools in the Archdiocese of Cincinnati to be determined

Cincinnati, Ohio, United States

Countries

United States

References

Tamm L, Peugh J. Concordance of teacher-rated and performance-based measures of executive functioning in preschoolers. Child Neuropsychol. 2019 Apr;25(3):410-424. doi: 10.1080/09297049.2018.1484085. Epub 2018 Jun 14.

Reference Type: DERIVED

PMID: 29902951 (View on PubMed)

Other Identifiers

FP00006613

Identifier Type: -

Identifier Source: org_study_id