title: The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics.
abstract: BACKGROUND
  Mental health problems and risk behaviours among young people are of great public health concern. Consequently, within the VII Framework Programme, the European Commission funded the Saving and Empowering Young Lives in Europe (SEYLE) project. This Randomized Controlled Trial (RCT) was conducted in eleven European countries, with Sweden as the coordinating centre, and was designed to identify an effective way to promote mental health and reduce suicidality and risk taking behaviours among adolescents.
  
  
  OBJECTIVE
  To describe the methodological and field procedures in the SEYLE RCT among adolescents, as well as to present the main characteristics of the recruited sample.
  
  
  METHODS
  Analyses were conducted to determine: 1) representativeness of study sites compared to respective national data; 2) response rate of schools and pupils, drop-out rates from baseline to 3 and 12 month follow-up, 3) comparability of samples among the four Intervention Arms; 4) properties of the standard scales employed: Beck Depression Inventory, Second Edition (BDI-II), Zung Self-Rating Anxiety Scale (Z-SAS), Strengths and Difficulties Questionnaire (SDQ), World Health Organization Well-Being Scale (WHO-5).
  
  
  RESULTS
  Participants at baseline comprised 12,395 adolescents (M/F: 5,529/6,799; mean age=14.9±0.9) from Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain. At the 3 and 12 months follow up, participation rates were 87.3% and 79.4%, respectively. Demographic characteristics of participating sites were found to be reasonably representative of their respective national population. Overall response rate of schools was 67.8%. All scales utilised in the study had good to very good internal reliability, as measured by Cronbach's alpha (BDI-II: 0.864; Z-SAS: 0.805; SDQ: 0.740; WHO-5: 0.799).
  
  
  CONCLUSIONS
  SEYLE achieved its objective of recruiting a large representative sample of adolescents within participating European countries. Analysis of SEYLE data will shed light on the effectiveness of important interventions aimed at improving adolescent mental health and well-being, reducing risk-taking and self-destructive behaviour and preventing suicidality.
  
  
  BACKGROUND
  US National Institute of Health (NIH) clinical trial registry (NCT00906620) and the German Clinical Trials Register (DRKS00000214).
authors.affiliation: National Centre for Suicide Research and Prevention of Mental Ill-Health (NASP), Karolinska Institutet, Stockholm, Sweden. vladimir.carli@ki.se
authors.forename: Vladimir
authors.initials: V
authors.lastname: Carli
authors.forename: Camilla
authors.initials: C
authors.lastname: Wasserman
authors.forename: Danuta
authors.initials: D
authors.lastname: Wasserman
authors.forename: Marco
authors.initials: M
authors.lastname: Sarchiapone
authors.forename: Alan
authors.initials: A
authors.lastname: Apter
authors.forename: Judit
authors.initials: J
authors.lastname: Balazs
authors.forename: Julio
authors.initials: J
authors.lastname: Bobes
authors.forename: Romuald
authors.initials: R
authors.lastname: Brunner
authors.forename: Paul
authors.initials: P
authors.lastname: Corcoran
authors.forename: Doina
authors.initials: D
authors.lastname: Cosman
authors.forename: Francis
authors.initials: F
authors.lastname: Guillemin
authors.forename: Christian
authors.initials: C
authors.lastname: Haring
authors.forename: Michael
authors.initials: M
authors.lastname: Kaess
authors.forename: Jean Pierre
authors.initials: JP
authors.lastname: Kahn
authors.forename: Helen
authors.initials: H
authors.lastname: Keeley
authors.forename: Agnes
authors.initials: A
authors.lastname: Keresztény
authors.forename: Miriam
authors.initials: M
authors.lastname: Iosue
authors.forename: Ursa
authors.initials: U
authors.lastname: Mars
authors.forename: George
authors.initials: G
authors.lastname: Musa
authors.forename: Bogdan
authors.initials: B
authors.lastname: Nemes
authors.forename: Vita
authors.initials: V
authors.lastname: Postuvan
authors.forename: Stella
authors.initials: S
authors.lastname: Reiter-Theil
authors.forename: Pilar
authors.initials: P
authors.lastname: Saiz
authors.forename: Peeter
authors.initials: P
authors.lastname: Varnik
authors.forename: Airi
authors.initials: A
authors.lastname: Varnik
authors.forename: Christina W
authors.initials: CW
authors.lastname: Hoven
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior / Q000523:psychology*; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D010352:Patient Dropouts / Q000706:statistics & numerical data; D011209:Power, Psychological; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D015203:Reproducibility of Results; D012107:Research Design; D012309:Risk-Taking; D000092864:Suicide Prevention