跳至主要内容
临床试验/NCT03991585
NCT03991585已完成不适用

Feasibility of the Musical Contour Regulation Facilitation (MCRF) Intervention to Promote Emotion Regulation in At-risk Preschoolers: A Clinical Pilot Study

University of Miami2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Change in emotional lability/negativity as measured by Emotion Regulation Checklist (ERC)

研究概览

简要总结

The purpose of this study is to see if music can help children practice how to manage their emotions.

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

  • Preschoolers aged 3 to 5 years old enrolled in a Head Start program
  • Must be able to speak fluent English
  • Must not have previously received music therapy services
  • Must regularly attend the Head Start program
  • Must have signed parental consent.

排除标准

  • Does not meet all inclusion criteria

结局指标

主要结局

Change in emotional lability/negativity as measured by Emotion Regulation Checklist (ERC)

时间窗: Baseline, 12 weeks

The Lability/Negativity subscale of the ERC is a 15-item, four-point Likert-type scale to assess emotional lability in children. Parents and teachers will complete the ERC pre- and post-intervention. Scores range from 15 to 60 points. Higher scores reflect greater emotional lability.

Change in behaviors as measured by the Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)

时间窗: Baseline, 12 weeks

The CBCL/1.5-5 is a 99-item, three-point Likert-type scale to assess internalizing behaviors, externalizing behaviors, attending behaviors, and aggressive in preschool-aged children. Parents will complete the CBCL/1.5-5 pre- and post-intervention. Scores range from 0 to 198 points. Higher scores reflect greater emotional problems.

Change in emotion regulation as measured by Emotion Regulation Checklist (ERC)

时间窗: Baseline, 12 weeks

The Emotion Regulation subscale of the ERC is an 8-item, four-point Likert-type scale to assess ER processes in children. Parents and teachers will complete the ERC pre- and post-intervention. Scores range from 8 to 32 points. Higher scores reflect greater emotion regulation.

Change in behaviors as measured by the Caregiver-Teacher Report Form (C-TRF)

时间窗: Baseline, 12 weeks

The C-TRF is a 99-item, three-point Likert-type scale to assess internalizing behaviors, externalizing behaviors, attending behaviors, and aggressive in preschool-aged children. Teachers will complete the CBCL/1.5-5 pre- and post-intervention. Scores range from 0 to 198 points. Higher scores reflect greater emotional problems.

次要结局

  • Percentage of study measures completed(12 weeks)
  • Percentage of child attendance(12 weeks)
  • Percentage of intervention components completed by interventionist(12 weeks)
  • Change in emotion regulation state as self-reported using the Self Assessment Manikin (SAM)(Pre-session, 20-minute post-session)
  • Change in emotion regulation state as observed using the Goal Attainment Scale (GAS)(Pre-session, 20-minute post-session)

研究者

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

Kimberly Sena Moore

Assistant Professor of Professional Practice

University of Miami

研究点 (2)

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