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临床试验/NCT02225236
NCT02225236已完成不适用

Improving Self-regulation & School Readiness in Preschoolers

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
237
试验地点
1
主要终点
Behavior Rating Inventory of Executive Function-Preschool Version

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children in preschool classrooms in selected schools.

排除标准

  • 未提供

研究组 & 干预措施

Classroom Intervention

Experimental

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.

干预措施: Classroom Intervention (Behavioral)

No treatment control

No Intervention

No intervention

结局指标

主要结局

Behavior Rating Inventory of Executive Function-Preschool Version

时间窗: 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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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