NCT00906620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,247

participants targeted

Target at P75+ for early_phase_1 depression

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

2.3 years

First QC Date

May 19, 2009

Last Update Submit

March 6, 2014

Conditions

DepressionSuicidality

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • evaluate the efficacy of different preventive programs.

    2012

Secondary Outcomes (1)

  • rate of risk taking behavior among adolescents

    2012

Study Arms (4)

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.

Other: QPR: question, persuade and refer (SEYLE)

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.

Other: QPR: question, persuade and refer (SEYLE)

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.

Other: QPR: question, persuade and refer (SEYLE)

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.

Other: QPR: question, persuade and refer (SEYLE)

Interventions

QPR: question, persuade and refer (SEYLE)OTHER

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.

Awareness programControl groupProfScreenQPR intervention

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents between 13-17

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schnider Children MC

Petah Tikva, NON, 49202, Israel

Location

Related Publications (3)

  • Lustig S, Kaess M, Schnyder N, Michel C, Brunner R, Tubiana A, Kahn JP, Sarchiapone M, Hoven CW, Barzilay S, Apter A, Balazs J, Bobes J, Saiz PA, Cozman D, Cotter P, Kereszteny A, Podlogar T, Postuvan V, Varnik A, Resch F, Carli V, Wasserman D. The impact of school-based screening on service use in adolescents at risk for mental health problems and risk-behaviour. Eur Child Adolesc Psychiatry. 2023 Sep;32(9):1745-1754. doi: 10.1007/s00787-022-01990-z. Epub 2022 Apr 30.

    PMID: 35488938DERIVED

  • 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, Kereszteny 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.

    PMID: 23679917DERIVED

  • 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.

    PMID: 23599019DERIVED

MeSH Terms

Conditions

DepressionSuicidal Ideation

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideSelf-Injurious Behavior

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Alan Stanley Apter, MD

    Schnider Children MC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of psychological medicine department at Schneider; Professor at Sackler School of medicine

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations

IL(1)