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临床试验/NCT07790588
NCT07790588尚未招募不适用

Project Leo: Trauma-Informed Yoga for Preschool Children and Parents

Florida Atlantic University2 个研究点 分布在 2 个国家目标入组 66 人开始时间: 2026年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
试验地点
2
主要终点
Child's Stress Symptoms

研究概览

简要总结

The goal of this pilot clinical trial is to examine feasibility, acceptability, and direction of effect of a dyadic (child and parent) trauma-informed yoga intervention on stress symptoms and sleep in young children (age 3-6) after war. The main questions it aims to answer are:

  • Is the intervention feasible and liked by the participants?
  • Does the child-parent yoga intervention reduce the child's stress symptoms and improve their sleep?
  • Does the child-parent yoga intervention improve the child-parent relationship?

Participants (child-parent dyads) will:

  • Children and parents will participate together in 8 weekly group yoga sessions.
  • Children and parents will engage together in a short daily at-home practice before bedtime.
  • Parents will complete online surveys before and after the 8-week program, and at one-month follow-up.
  • Parents will complete a daily practice-sleep log.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Children: Age 3-
  • Per the parent's report, the child exhibits at least one stress-related symptom.
  • Parents: Preferably, the same parent can attend all group sessions. Having internet access at home to complete online surveys.

排除标准

  • Children: Any physical disability that prevents participating safely in yoga sessions.
  • Parents: Self-reported pregnancy. Any physical disability that prevents participating safely in gentle yoga sessions.

结局指标

主要结局

Child's Stress Symptoms

时间窗: 8 weeks

Presence and severity of stress symptoms will be assessed (parent-reported) using the Young Child PTSD Checklist (YCPC). The 30-item scale yields a sum score ranging from 0 to 120, with higher scores indicating more severe stress symptoms.

Child's Sleep Quality

时间窗: 8 weeks

The child's sleep quality will be assessed (parent-reported) using the Children's Sleep Habits Questionnaire Abbreviated (CSHQ). The 22-item scale yields a sum score ranging from 0 to 88, with higher scores indicating more severe sleep problems.

次要结局

  • Child-Parent Relationship: Closeness(8 weeks)
  • Child-Parent Relationship: Conflict(8 weeks)
  • Parent's Stress Symptoms(8 weeks)
  • Parent's Sleep Quality(8 weeks)
  • Parental Self-Efficacy(8 weeks)
  • Child's Pain Severity(8 weeks)
  • Child's Pain Interference(8 weeks)
  • Parent's Pain Severity(8 weeks)
  • Parent's Pain Interference(8 weeks)

研究者

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

Shahar Almog

Senior Research Fellow

Florida Atlantic University

研究点 (2)

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