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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
alan apter, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00906620
First received: May 19, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Depression
Suicidality
Other: QPR: question, persuade and refer (SEYLE)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Saving and Empowering Young Lives in Europe in Israel, Evaluation, Intervention and Prevention

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • evaluate the efficacy of different preventive programs. [ Time Frame: 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of risk taking behavior among adolescents [ Time Frame: 2012 ] [ Designated as safety issue: No ]

Enrollment: 1247
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescents between 13-17

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906620

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

No publications provided by Rabin Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: alan apter, Director of psychological medicine department at Schneider; Professor at Sackler School of medicine, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00906620     History of Changes
Other Study ID Numbers: 5277
Study First Received: May 19, 2009
Last Updated: March 6, 2014
Health Authority: Israel: Ethics Commission

Keywords provided by 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
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014