跳至主要内容
临床试验/NCT04642157
NCT04642157招募中不适用

Online Referral and Intervention to Prevent Adolescent and Young Adult Suicide

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 396 人开始时间: 2022年10月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
396
试验地点
1
主要终点
the change of the intensity of the severest suicidal ideation experienced in the past week by the participants.

研究概览

简要总结

ORIAS is a randomized controlled trial designed to study the efficacy of the ELIOS system in reducing suicidality in the AYA, reinforcing their motivation to seek help and making them access to care.

As ELIOS would be the first suicide prevention system worldwide entirely tailored to the AYA contemporaneous modes of interaction on social media, ORIAS was designed to address the challenge of deciding whether this innovation is worth adding to the current national and international prevention arsenal. While randomized control trials are crucially lacking in the field of suicide prevention, especially on the Internet, the high-level evidence that ORIAS is expected to bring could have a decisive influence on how the French prevention strategies will seize the social media.

详细描述

ELIOS will consist in a digital system that distressed users can contact via different social media or traditional communication channels. Participants randomized to the ELIOS group will be offered to interact online with a web-clinician who will deliver adapted interventions to alleviate their distress and refer them to appropriate care.The ELIOS web-clinicians will be psychologists and nurses supervised by a psychiatrist, specially trained to carry out crisis, counselling and motivational at distance interventions with AYA. In addition, they will receive a special training module dedicated to the interaction constraints and possibilities that the social media imply, but also to the textual and iconographic communication modalities. Human resources of ELIOS will be shared with those of the VigilanS program.

The ORIAS study primarily aims at showing the superiority of the ELIOS system in decreasing suicidality at 3 months in comparison to simple professional contact delivery among the AYA who seek help online for suicidal ideations.

With that purpose, participants will be randomly allocated to 2 parallel arms

  • In addition to receiving the same generic mental health resources as in the control group, the participants of the ELIOS arm will benefit from the intervention of the ELIOS team. This includes an initial systematic contact with an ELIOS web-clinician, systematic recontacts by the ELIOS web-clinicians, scheduled at 24h, 72h and/or 7 days, depending on the participants' level of suicide risk and the opportunity to spontaneously contact the ELIOS system and get in contact with a web-clinician. All the ELIOS interventions will be subordinated to the two main goals of reducing the users' distress and suicidality and achieving an effective referral to the mental health care services. To do so, the web-clinicians will variably combine three complementary psychotherapeutic techniques: crisis intervention, counselling and motivational guidance. The interventions will be constrained by the imperative of rapidly bringing the participants from social media channels to more engaging channels (phone call or video-conference) in order to gain degrees of freedom in the interaction.
  • Participants of the control arm will receive generic professional help contacts. Three types of resources will be suggested via the ELIOS website: the General Practitioner (GP), the closest Medical and Psychological Center, the emergency services. The order of presentation of the resource contacts will depend on the participants' intensity of suicidal ideation.

In both arms, data will be collected by means of online self-questionnaire before the intervention or provision of resource contacts (T0) and 3 months later (T1).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •To spontaneously contact the ELIOS online system
  • •To have been experiencing suicidal ideations in the week prior the contact
  • •To live in France and speak French
  • •To provide informed consent
  • •For ethical reasons, we decided not to include minors, due to impossibility of getting the parental authorizations without compromising the facilitation role of the system. However, most recent expert consensus consider that adolescence extends to 25 years old.

排除标准

  • •To contact the ELIOS online system for a relative or an acquaintance

研究组 & 干预措施

ELIOS group

Experimental

In addition to receiving the same generic mental health resources as in the control group, the participants of the ELIOS arm will benefit from the intervention of the ELIOS team.

干预措施: ELIOS (Other)

control group

Other

Participants of the control arm will receive generic professional help contacts.

干预措施: other resources contacts (Other)

结局指标

主要结局

the change of the intensity of the severest suicidal ideation experienced in the past week by the participants.

时间窗: from baseline to the 3-months follow-up

The intensity of suicidal ideation will be measured by the total score on the Intensity of Ideation (IoI) subscale of the Columbia Suicide Severity Rating Scale (C-SSRS)

次要结局

  • Access to care after a suicide attempt(within the 3-months follow-up period)
  • psychological pain(at 3 months)
  • Score at the French version of the Client Satisfaction Questionnaire-8 (CSQ-8)(at 3 months)
  • Rate of successful recontacts (recontacts with a response)(Through study completion, an average of 3 months)
  • Mortality(at 3 months)
  • Suicide attempt(within the 3-months follow-up period)
  • Score at the Attitudes Toward Seeking Professional Psychological Help Scale - Short Form (ATSPPH-SF) care(at 3 months)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验