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临床试验/NCT04686162
NCT04686162Unknown不适用

Bae: A Smartphone Application for a Better Following Adolescents at Risk of Suicidal

University Hospital, Montpellier0 个研究点目标入组 100 人开始时间: 2021年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Acceptability

研究概览

简要总结

Suicidal behavior among adolescents is a major public health problem. Exacerbation of suicidal risk most often occurs when the young person is in his or her natural environment, far from the health care system. Therefore, real-time risk detection would make it possible to deploy immediate action interventions. A smartphone application for personalized assessment and intervention would enable patients to better anticipate and manage suicidal crises and stay connected to the healthcare system. The increasing use of smartphones and mobile applications among adolescents supports the feasibility and value of such follow-up among young people. In a first phase of this project, investigators first undertook to develop bae: a smartphone application adapted to a population of adolescents collecting information on their suicidal behaviour in a contextualized manner, with the added benefit of offering emotion management modules as well as personalized psychoeducational messages and alerts delivered to young people in the event of a crisis. The application is intended to be a complementary tool to the usual treatment. Before testing its effectiveness and due to the novelty of the intervention, a rigorous feasibility study in a real clinical context is necessary to ensure acceptability and satisfaction with the use of the bae application.

The objective is to evaluate, over a 6-month period, the acceptability of a follow-up of a population of 100 adolescents (12-17 years) at risk of suicidal driving via the bae smartphone application.

详细描述

100 patients having recently attempted suicide or having suicidal ideation will be recruited. They will be asked to use the application bae during 6 months and will be followed up during this period.

Initial visit (inclusion) : clinical assessment and installation of the application bae.

Last visit (6th month) : clinical assessment.

研究设计

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

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Criteria for inclusion
  • •All subjects will be required to meet the following inclusion criteria:
  • •Having consulted in the context of a suicidal crisis according to the criteria defined according to the consensus conference of the High Authority of Health (HAS 2000) ("psychic crisis for which the major risk is suicide. It can be represented as the trajectory that goes from the pejorative feeling of being in a situation of failure to a perceived impossibility of escaping this impasse. It is accompanied by suicidal ideas that become more and more pervasive and pervasive until the eventual act is carried out") in the previous 7 days.
  • •Possess a compatible smartphone (operating system: iOs or Androïd)
  • •Subject affiliated to or beneficiary of a French social security scheme
  • •Be able to understand the nature, purpose and methodology of the study
  • •Informed consent signed by the patient and his/her parent(s) or legal representative(s)

排除标准

  • •Patient deprived of liberty (by judicial or administrative decision)
  • •Inability to understand, speak and write French
  • •Participation in another study with an exclusion period.

研究组 & 干预措施

Group using the smartphone application bae

Experimental

Patients with personal history of suicide attempt or with suicidal ideation, will use the application during 6 months.

干预措施: bae application (Other)

结局指标

主要结局

Acceptability

时间窗: at 6 months

Rate of completion of the ecological momentary assessment questionnaires.

次要结局

  • Prevention modules use(6 months)
  • Satisfation(1, 2, 3, 4, 5 and 6 months)
  • Satisfaction(6 months)
  • Call module use(6 months)
  • Occurrence of a suicidal event(6 months)

研究者

申办方类型
Other
责任方
Sponsor

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