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Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study

2026年9月3日 更新者：Liat Itzhaky、Columbia University

The goal of this study is to finalize a version of the Safety Planning Intervention suitable for 6-12-year-old children. This intervention provides individuals with strategies to reduce the risk of suicidal behavior.

The main questions it aims to answer are:

  1. Does the intervention appear clear and acceptable to the children and caregivers?
  2. Does the intervention work to reduce suicidal behavior? Researchers will compare the group that received the intervention to a group that did not receive it, and to a group that received it and reported daily on its use.

Participants will:

  1. Children and parents will respond to questions in an interview and through self-reports in an in-person meeting
  2. Children and parents will receive the intervention (those in the intervention groups)
  3. Parents will report daily for one month (only those in the intervention + reporting group)
  4. Children and parents will meet with the study team through a video call at 1 and 3 months from the first meeting for an interview.

研究概览

地位

邀请报名

条件

干预/治疗

研究类型

介入性

注册 (估计的)

90

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。

学习地点

  • 美国
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Children Hospital of Philadelphia

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

接受健康志愿者

不

描述

Inclusion Criteria:

  • Children aged 6-12
  • Active suicidal ideation or a suicidal behavior in the last month
  • The child and their caregiver are English speakers
  • The child will be in an outpatient treatment at CHOP at the time of enrollment and baseline procedures

Exclusion Criteria:

  • Child received a diagnosis of a psychotic disorder or intellectual disability
  • Child is suffering from active mania

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：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：照常治疗 (TAU)
实验性的：Child-safety planning intervention (C-SPI) + TAU
Child - Safety Planning Intervention
行为的：Child - Safety Planning Intervention
The Child Safety Planning Intervention (C-SPI) provides psychoeducation to children and caregivers about emotions, thoughts, and behaviors, emphasizing how these interact and change over time. Suicidal thoughts are framed as temporary reactions to triggers that can be recognized and managed. The intervention reviews a recent suicidal crisis to identify triggers, thoughts, feelings, and behaviors, which are then used to help the child recognize warning signs in the future. These signs are organized into levels (green, yellow, red), each linked to specific action steps.
其他名称：
  • C-SPI
其他：C-SPI + TAU + ecological momentary assessment
Child - Safety Planning Intervention and daily reporting
行为的：Child - Safety Planning Intervention
The Child Safety Planning Intervention (C-SPI) provides psychoeducation to children and caregivers about emotions, thoughts, and behaviors, emphasizing how these interact and change over time. Suicidal thoughts are framed as temporary reactions to triggers that can be recognized and managed. The intervention reviews a recent suicidal crisis to identify triggers, thoughts, feelings, and behaviors, which are then used to help the child recognize warning signs in the future. These signs are organized into levels (green, yellow, red), each linked to specific action steps.
其他名称：
  • C-SPI
行为的：C-SPI+ecological momentary assessment
C-SPI and daily, self-reported use of C-SPI
其他名称：
  • 欧洲市场协会
  • C-SPI

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
Feasibility and acceptability of the C-SPI
大体时间：At baseline (following the intervention), and at 1 and 3 months follow-ups
Whether intervention is clear and perceived as helpful on a scale of 1-5 (higher score indicates better perception of helpfulness)
At baseline (following the intervention), and at 1 and 3 months follow-ups
Utilization of the C-SPI
大体时间：Daily for a month (through EMA), and at 1 and 3 month follow-ups
Whether the C-SPI was used or not (0 or 1)
Daily for a month (through EMA), and at 1 and 3 month follow-ups
Suicidal behavior
大体时间：1 and 3 months
Whether suicidal behavior was present and how many times (count variable beginning with zero; higher score indicating worse outcome)
1 and 3 months
Suicidal ideation severity
大体时间：1 and 3 months
On a scale of 0-5 with higher score indicating worse outcome
1 and 3 months

次要结果测量

结果测量
措施说明
大体时间
Mental health treatment engagement/service utilization
大体时间：1 and 3 months
Number of contact with mental health providers (count variable beginning with zero; higher score indicating better outcome)
1 and 3 months

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。

赞助

Columbia University

合作者

Children's Hospital of Philadelphia
American Foundation for Suicide Prevention

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9月9日

初级完成 (估计的)

2027年5月31日

研究完成 (估计的)

2027年5月31日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AAAV3403

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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