Clinical trial NCT02225236: Improving Self-regulation & School Readiness in Preschoolers
Official title: Improving Self-regulation & School Readiness in Preschoolers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Executive Dysfunction
Keywords: executive functioning
metacognition
self-regulation
preschoolers
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Brady Education Foundation
First posted: 2014-08-26
Enrollment: 237
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

All children in preschool classrooms in selected schools.

Exclusion Criteria:

None

Primary outcomes:
measure: Behavior Rating Inventory of Executive Function-Preschool Version
timeFrame: Outcome assessment (~9 months after initial assessment)
Secondary outcomes:
measure: Clinical Evaluation of Language Fundamentals - Preschool, Second Edition - Concepts and Following Directions
timeFrame: Outcome evaluation (~9 months after baseline evaluation)
measure: NEPSY- Attention/Executive Function subtests
timeFrame: Outcome (~9 months after baseline evaluation)
measure: Shape School
timeFrame: Outcome (~9 months after baseline evaluation)
measure: Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Teacher Rating Scale
timeFrame: Outcome (~9 months after baseline evaluation)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Schools in the Archdiocese of Cincinnati to be determined
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Leanne Tamm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.