Saving and Empowering Young Lives in Europe (Israel) (SEYLE-ISRAEL)

• ClinicalTrials.gov Identifier: NCT00906620
• Recruitment Status: Completed
• First Posted: May 21, 2009
• Last Update Posted: March 7, 2014
• Sponsor: Rabin Medical Center
• Information provided by (Responsible Party): alan apter, Rabin Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Depression; Suicidality	Other: QPR: question, persuade and refer (SEYLE)	Early Phase 1

Detailed Description:

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1247 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Saving and Empowering Young Lives in Europe in Israel, Evaluation, Intervention and Prevention
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: QPR intervention; 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.	Other: QPR: question, persuade and refer (SEYLE); 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.
Experimental: Awareness program; 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.	Other: QPR: question, persuade and refer (SEYLE); 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.
Experimental: ProfScreen; 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.	Other: QPR: question, persuade and refer (SEYLE); 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.
Experimental: Control group; 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.	Other: QPR: question, persuade and refer (SEYLE); 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.

Outcome Measures

Primary Outcome Measures :

1. evaluate the efficacy of different preventive programs. [ Time Frame: 2012 ]

Secondary Outcome Measures :

1. rate of risk taking behavior among adolescents [ Time Frame: 2012 ]

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Adolescents between 13-17

Exclusion Criteria:

• none

Contacts and Locations

Locations

Israel

Schnider Children MC

Petach-Tikva, NON, Israel, 49202

Sponsors and Collaborators

Rabin Medical Center

Investigators

• Principal Investigator: Alan Stanley Apter, MD; Schnider Children MC

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Carli V, Wasserman C, Wasserman D, Sarchiapone M, Apter A, Balazs J, Bobes J, Brunner R, Corcoran P, Cosman D, Guillemin F, Haring C, Kaess M, Kahn JP, Keeley H, Keresztény A, Iosue M, Mars U, Musa G, Nemes B, Postuvan V, Reiter-Theil S, Saiz P, Varnik P, Varnik A, Hoven CW. The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics. BMC Public Health. 2013 May 16;13:479. doi: 10.1186/1471-2458-13-479.

Kelleher I, Keeley H, Corcoran P, Ramsay H, Wasserman C, Carli V, Sarchiapone M, Hoven C, Wasserman D, Cannon M. Childhood trauma and psychosis in a prospective cohort study: cause, effect, and directionality. Am J Psychiatry. 2013 Jul;170(7):734-41. doi: 10.1176/appi.ajp.2012.12091169.

• Responsible Party: alan apter, Director of psychological medicine department at Schneider; Professor at Sackler School of medicine, Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT00906620
• Other Study ID Numbers: 5277
• First Posted: May 21, 2009
• Last Update Posted: March 7, 2014
• Last Verified: March 2014

Keywords provided by alan apter, Rabin Medical Center:

Data on student's healthy and at-risk lifestyles and their relation with health measured by well-being, depression and suicidality

Additional relevant MeSH terms:

Depression; Behavioral Symptoms