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临床试验/NCT00906620
NCT00906620已完成1 期

Saving and Empowering Young Lives in Europe in Israel, Evaluation, Intervention and Prevention

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 1,247 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
1,247
试验地点
1
主要终点
evaluate the efficacy of different preventive programs.

研究概览

简要总结

SEYLE is a health promoting program for adolescents in European schools. Its main objectives are to lead adolescents to better health through decreased risk-taking and suicidal behaviors, to evaluate outcomes of different preventive programs and to recommend effective culturally adjusted models for promoting health of adolescents in different European countries. Because of the significance of the SEYLE program and the importance of suicide research, Israel is honored to take part in this program and be a collaborator in it's implementation and research.

详细描述

In this health promotion program, a pilot intervention study will be implemented to assess the effects of three different health promoting / suicide prevention programs in 11,000 students across 11 European countries (Sweden, Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain): 1. A general health promotion program targeting students' awareness on healthy/unhealthy behaviours and students' self-efficacy in diminishing unhealthy behaviours; 2. ProfScreen - screening by professionals of at-risk students through a questionnaire. For adolescents identified as high risk (screen positives) the program includes referral to mental health treatment and ensuring compliance. 3. QPR (Question, Persuade & Refer) - a gatekeepers' program, training all adult staff at schools (teachers, counselors, nurses etc.) and parents on how to recognize & refer a student with risk-taking behaviours or suffering from mental illness to mental-health help resources.

Each of these prevention programs uses a different active component in order to be successful. The first prevention program empowers the students by increasing their self-efficacy. The second prevention program (ProfScreen) empowers mental health professional in identifying subjects at risk. The third program (QPR) empowers teachers and parents in at-risk case finding and referring to mental health facilities. The registration of the complete RCT is available on the German Clinical Trials Registry (DRKS00000214).

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
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Adolescents between 13-17

排除标准

  • 未提供

研究组 & 干预措施

QPR intervention

Experimental

QPR intervention (Question, Persuade & Refer): The QPR prevention program will be used in two modules, one for school staff and one for parents. According to the US Surgeon General's National Strategy for Suicide Prevention (2001), "key gatekeepers" are "people who regularly come into contact with individuals or families in distress" and gatekeeper training has been identified as one of a number of promising prevention strategies.

干预措施: QPR: question, persuade and refer (SEYLE) (Other)

Awareness program

Experimental

The awareness programme is comprised of a leaflet, six posters and four seminars. The seminars are made up of one introductory lesson, and two interactive follow-up lessons with role play and one final meeting as a closing/debriefing lesson.

干预措施: QPR: question, persuade and refer (SEYLE) (Other)

ProfScreen

Experimental

The program's primary objective is to help young people and their parents through the early identification of mental health problems, such as anxiety, depression, substance abuse, and suicide. Screening strategies are based on the valid premise that suicidal adolescents are under-identified, suffer from an active, often treatable mental illness such as depression and exhibit identifiable risk factors (Gould et al. 2003). A potential shortcoming of screening programs is that asking about suicide could increase suicidal ideation and behaviour. About this issue a recent study (Gould et al . 2005) on over 2300 students reported no evidence of iatrogenic effects of suicide screening and that screening in high schools is a safe component of youth suicide prevention efforts.

干预措施: QPR: question, persuade and refer (SEYLE) (Other)

Control group

Experimental

The control group will comprise 250 subjects. After the baseline assessment, subjects will be randomized in one of the three intervention arms or in the control group. Individuals in the control group will undergo the same baseline and follow-up evaluations as subjects in the intervention arms and will receive the same leaflet about healthy lifestyles with information about the possibility to seek help for unhealthy, suicidal behaviour and mental health problems. In this arm, no additional intervention will be performed although the possibility of seeking help from mental health resources will be available.

干预措施: QPR: question, persuade and refer (SEYLE) (Other)

结局指标

主要结局

evaluate the efficacy of different preventive programs.

时间窗: 2012

次要结局

  • rate of risk taking behavior among adolescents(2012)

研究者

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

alan apter

Director of psychological medicine department at Schneider; Professor at Sackler School of medicine

Rabin Medical Center

研究点 (1)

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