The Saving and Empowering Young Lives in Europe (SEYLE) Randomized Controlled Trial (RCT): methodological issues and participant characteristics
Creators: name: Carli, Vladimir
name: Wasserman, Camilla
name: Wasserman, Danuta
name: Sarchiapone, Marco
name: Apter, Alan
name: Balazs, Judit
name: Bobes, Julio
name: Brunner, Romuald
name: Corcoran, Paul
name: Cosman, Doina
name: Guillemin, Francis
name: Haring, Christian
name: Kaess, Michael
name: Kahn, Jean
name: Keeley, Helen
name: Keresztény, Agnes
name: Iosue, Miriam
name: Mars, Ursa
name: Musa, George J.
name: Nemes, Bogdan
name: Postuvan, Vita
name: Reiter-Theil, Stella
name: Saiz, Pilar
name: Varnik, Peeter
name: Varnik, Airi
name: Hoven, Christina
Publisher: name: Columbia University
Year: 2013
Subjects: Youth--Mental health
Youth--Mental health services
Suicide--Prevention
Youth--Suicidal behavior--Prevention
Mental health promotion
Public health

description: 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. Trial registration: US National Institute of Health (NIH) clinical trial registry (NCT00906620) and the German Clinical Trials Register (DRKS00000214).