Project Leo: Trauma-Informed Yoga for Preschool Children and Parents
2026年8月26日 更新者：Shahar Almog、Florida Atlantic University
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.
研究概览
研究类型
介入性
注册 (估计的)
66
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Shahar Almog, PhD
- 电话号码：+1 (561) 2973461
- 邮箱：salmog@fau.edu
研究联系人备份
- 姓名：Noga Tsur, PhD
- 邮箱：nogatsur@tauex.tau.ac.il
学习地点
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Tel Aviv、以色列
- Tel Aviv University
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接触：
- Noga Tsur, PhD
- 电话号码：0000000000
- 邮箱：nogatsur@tauex.tau.ac.il
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首席研究员：
- Noga Tsur, PhD
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Florida
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Boca Raton、Florida、美国、33431
- Florida Atlantic University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Children: Age 3-6. 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.
Exclusion Criteria:
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention
Dyadic (Child-Parent) Yoga
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Participants will attend 8 weekly group sessions of dyadic (child and parent) yoga and engage in at-home practice at bedtime.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Child's Stress Symptoms
大体时间：8 weeks
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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.
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8 weeks
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Child's Sleep Quality
大体时间：8 weeks
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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.
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8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Child-Parent Relationship: Closeness
大体时间：8 weeks
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The quality of the child-parent relationship will be assessed (parent-reported) using the Child-Parent Relationship Scale - Short Form (CPRS-SF), specifically the Closeness subscale.
The 7-item subscale yields a sum score of 7 to 35, with higher scores indicating greater closeness.
Higher closeness scores reflect better relationship between the child and the parent.
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8 weeks
|
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Child-Parent Relationship: Conflict
大体时间：8 weeks
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The quality of the child-parent relationship will be assessed (parent-reported) using the Child-Parent Relationship Scale - Short Form (CPRS-SF), specifically the Conflict subscale.
The 8-item subscale yields a sum score of 8 to 40, with higher scores indicating greater conflict.
Lower conflict scores reflect better relationship between the child and the parent.
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8 weeks
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Parent's Stress Symptoms
大体时间：8 weeks
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Presence and severity of post-traumatic stress symptoms will be assessed (self-reported) using the PCL-5 scale.
The 20-item scale yields a sum score ranging from 0 to 80, with higher scores indicating more severe post-traumatic stress symptoms.
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8 weeks
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Parent's Sleep Quality
大体时间：8 weeks
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The parent's sleep quality will be assessed (self-reported) using the Sleep Disturbance PROMIS SF 8b.
The 8-item scale yields a sum score ranging from 8 to 40, with higher scores indicating more severe sleep problems.
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8 weeks
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Parental Self-Efficacy
大体时间：8 weeks
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The parent's self-confidence in their ability to handle their child's behavior problems will be assessed (self-reported) by the Brief Parental Self-Efficacy Scale.
The 5-item scale yields a sum score ranging from 5 to 20, with higher scores indicating greater self-confidence.
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8 weeks
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Child's Pain Severity
大体时间：8 weeks
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If the child experiences pain, pain severity will be assessed (parent-reported) using one item from the Brief Pain Inventory (BPI).
Pain severity will be rated on a scale from 0 to 10, with higher rating indicating more severe pain.
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8 weeks
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Child's Pain Interference
大体时间：8 weeks
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If the child experiences pain, pain interference with routine activities will be assessed (parent-reported) using one item from the Brief Pain Inventory (BPI).
The level of how much the pain interferes with routine activities will be rated on a scale from 0 to 10, with higher ratings indicating greater interference.
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8 weeks
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Parent's Pain Severity
大体时间：8 weeks
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If the parent experiences pain, pain severity will be assessed (self-reported) using one item from the Brief Pain Inventory (BPI).
Pain severity will be rated on a scale from 0 to 10, with higher rating indicating more severe pain.
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8 weeks
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Parent's Pain Interference
大体时间：8 weeks
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If the parent experiences pain, pain interference will be assessed (self-reported) using two items from the Brief Pain Inventory (BPI).
The level of how much the pain interferes with (a) enjoyment in life and with (b) routine activities will be rated on a scale from 0 to 10, with higher ratings indicating greater interference.
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8 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility: Recruitment
大体时间：Recruitment period, from initiation until the start day of the intervention
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Recruitment will be calculated as the proportion of enrolled participants to interested individuals during the recruitment period.
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Recruitment period, from initiation until the start day of the intervention
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Feasibility: Intervention Retention
大体时间：8 weeks
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Retention will be calculated as the proportion of participants who completed the intervention to participants who gave their consent to participate.
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8 weeks
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Feasibility: Intervention Adherence
大体时间：8 weeks
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Percentage of participants completing at least 75% of the group sessions AND at least 4 at-home practices per week.
Group session attendance will be monitored by the research team.
At-home practice will be self-reported via a daily practice log.
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8 weeks
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Acceptability: Liking
大体时间：8 weeks
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Parents will be asked if they liked the intervention on a scale of 0 to 10, with higher ratings indicating greater liking and better acceptability of the intervention among parents.
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8 weeks
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Acceptability: Recommending
大体时间：8 weeks
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Parents will be asked about the likelihood that they would recommend the program to others, rated from 0 to 100%, with higher ratings indicating a greater likelihood of recommending the intervention and better acceptability of the intervention among parents.
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8 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Shahar Almog, PhD、Florida Atlantic University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月5日
初级完成 (估计的)
2027年2月10日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年8月19日
首先提交符合 QC 标准的
2026年8月26日
首次发布 (实际的)
2026年8月27日
研究记录更新
最后更新发布 (实际的)
2026年8月27日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.