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临床试验/NCT04171089
NCT04171089撤回不适用

Suicide Prevention in Prepubertal Children

New York State Psychiatric Institute1 个研究点 分布在 1 个国家开始时间: 2019年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Feasibility of the Child-Safety Plan Intervention

研究概览

简要总结

Suicidal ideation and behaviors are estimated to be as high as 4-16% and 1.5% (respectively) in the general 6-12-year-old population. However, there are currently no validated suicide prevention interventions specifically developed for this population.

This study aims to: (1) test the feasibility and acceptability of the Safety Planning Intervention for prepubertal Children (C-SPI) in 30 children (ages 6-12) who have made a suicide threat, suicidal behavior or reported suicidal ideation, and their parents, and (2) improve the investigator's understanding of suicidal ideation and behaviors in this age group. The results from the current project will be used to further develop the C-SPI, and to develop preliminary guidance and associated policy for clinicians to use.

详细描述

The Safety Planning Intervention (SPI) is a brief, protocol-driven and individually tailored tool that uses evidence-based practices for suicide prevention. The SPI aims to provide the individual with quick distraction and coping tools to overcome a suicidal crisis without acting upon the suicidal thoughts. The SPI was used in the Treatment for Adolescents Suicide Attempters study in youth 12-19 and has been found to be feasible and acceptable among adult patients and staff as well as among clinicians who work with adolescents. Its effectiveness in reducing suicide risk among veterans has also been confirmed. The SPI could be a good fit for children, as it uses concrete ways for the person to recognize their reaction, as well as concrete methods to cope with distress, which fits with the developmental stage of prepubertal children. Moreover, the collaborative way in which the personal safety plan is tailored to the suicidal person will allow the engagement of the child in the intervention. The SPI is an intervention that is relatively easy to administer and, therefore, if found to be appropriate for this age group, it could be implemented in different child-focused settings, including schools. The aim of the study is to evaluate the acceptability and feasibility of the Safety Planning Intervention for prepubertal Children's (C-SPI) among suicidal children and their parents. Additionally, children will be interviewed and be assessed for impulsivity, attention bias, irritability and coping skills.

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
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Suicidal thoughts or threats in the last six month or suicidal behavior in lifetime
  • The child and his parent/guardian are English speakers
  • Having a parent /guardian consent to the child participating in this study
  • The clinician confirmed that the parents are suitable to take part in the intervention

排除标准

  • Diagnosis of a psychotic disorder
  • Intellectual disability

结局指标

主要结局

Feasibility of the Child-Safety Plan Intervention

时间窗: Baseline

The Patient Satisfaction Survey is a 12-item self-report questionnaire (child and parents versions), half of the items assess the feasibility of the child-safety plan intervention in this age group.

Acceptability of the Child-Safety Plan Intervention

时间窗: Baseline

The Patient Satisfaction Survey is a 12-item self-report questionnaire (child and parents versions), half of the items assess the acceptability of the child-safety plan intervention in this age group.

次要结局

  • Child's coping skills(Baseline)
  • Child's conceptual level of death(Baseline)
  • Child's symptoms of irritability(Baseline)
  • Child's attention bias(Baseline)
  • Child's impulsivity(Baseline)

研究者

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

Beth Brodsky

Associate Director

New York State Psychiatric Institute

研究点 (1)

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