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临床试验/NCT06647693
NCT06647693进行中(未招募)不适用

Do Motor Synchrony Games Improve Self Regulation?

Appalachian State University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
24
试验地点
2
主要终点
Stop and Go Sequence

研究概览

简要总结

The goal of this study is to determine if progressively more challenging playground games (motor synchrony games) improve executive function in preschool-aged children.

详细描述

Self-regulation (SR) skills in early childhood predict later academic achievement and protect against developing internalizing and externalizing problems such as depressive symptoms or aggressive behavior (McClelland et al., 2019; Robson et al., 2020). One way to target SR skills is to use a program that involves motor synchrony games (e.g., musical freeze) (Gibb et al., 2021; McClelland et al., 2019; Zelazo et al., 2018). This study seeks to implement a similar motor synchrony games protocol in mixed ability groups to target SR. The investigators plan to use a multiple baseline design, a type of single case experimental design, to characterize the growth for individual participants.

The specific aims are as follows:

Aim 1: To determine if targeted motor synchrony games can achieve an increase in SR.

Aim 2: To examine how individual participants, including those with and without disabilities, respond to the protocol.

(Protocol modified in October:) Aim 3: Determine if hurricane Helene impacted the self-regulation of participants

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Investigator and research assistant will not be blind. A second blinded research assistant will complete reliability.

入排标准

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

入选标准

  • Enrolled in the preschool classroom
  • Express at least one word
  • Runs independently

排除标准

  • Known motor disorder
  • Parents report the child cannot hear spoken language
  • Parents report the child cannot see person gesturing 10 feet away

结局指标

主要结局

Stop and Go Sequence

时间窗: Twice weekly for approximately 12 weeks

Participants are asked to "stop" and then "go" in progressively more challenging ways. The purpose is to measure self-regulation (specifically the inhibition executive function ability)

NIH Toolbox

时间窗: Implemented 5 times - initial evaluation, before beginning intervention (~6, 9, or 12 sessions), post-hurricane Helene, approximately 12 weeks after initial evaluation, approximately 2 month follow-up)

Card Sort \& Picture Vocabulary. The purpose is to measure behavioral self-regulation / executive function (Card Sort) and also language (Picture Vocabulary)

Head, Toes, Knees, Shoulders - Revised

时间窗: Implemented 5 times - initial evaluation, before beginning intervention (~6, 9, or 12 sessions), post-hurricane Helene, approximately 12 weeks after initial evaluation, approximately 2 month follow-up)

HTKS-R (Gonzales, 2021). The purpose is to measure behavioral self-regulation.

次要结局

  • Imitation Score(Twice weekly for approximately 12 weeks)
  • Patient reported outcome measures(Twice weekly for approximately 12 weeks)
  • BRIEF-P(Initial and about 12 weeks after (twice))
  • Stop latency(The investigators had initially planned four times (initial, after baseline, about 12 weeks after, and the two 2 month follow up), but due to mat availability, the investigators are only going to complete this outcome measure twice)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

George Wolford

Assistant Professor

Appalachian State University

研究点 (2)

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