Open Access Research article

The Saving and Empowering Young Lives in Europe (SEYLE) Randomized Controlled Trial (RCT): methodological issues and participant characteristics

Vladimir Carli12*, Camilla Wasserman34, Danuta Wasserman12, Marco Sarchiapone4, Alan Apter5, Judit Balazs67, Julio Bobes8, Romuald Brunner109, Paul Corcoran11, Doina Cosman12, Francis Guillemin13, Christian Haring14, Michael Kaess109, Jean Pierre Kahn15, Helen Keeley11, Agnes Keresztény167, Miriam Iosue4, Ursa Mars17, George Musa3, Bogdan Nemes12, Vita Postuvan17, Stella Reiter-Theil1819, Pilar Saiz8, Peeter Varnik20, Airi Varnik21 and Christina W Hoven213

Author Affiliations

1 National Centre for Suicide Research and Prevention of Mental Ill-Health (NASP), Karolinska Institutet, Stockholm, Sweden

2 WHO Collaborating Center for Research, Methods Development and Training in Suicide Prevention, Stockholm, Sweden

3 Department of Child and Adolescent Psychiatry, Columbia University-New York State Psychiatric Institute, New York, USA

4 Department of Health Sciences, University of Molise, Campobasso, Italy

5 Feinberg Child Study Centre, Schneider Children’s Medical Centre, Tel Aviv University, Tel Aviv, Israel

6 Vadaskert Child and Adolescent Psychiatric Hospital, Budapest, Hungary

7 Institute of Psychology, Eötvös Loránd University, Budapest, Hungary

8 Department of Psychiatry, University of Oviedo, Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM, Oviedo, Spain

9 Section for Disorders of Personality Development, Clinic of Child and Adolescent Psychiatry, Heidelberg, Germany

10 Centre of Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany

11 National Suicide Research Foundation, Cork, Ireland

12 Clinical Psychology Department, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania

13 Inserm CIC-EC, Nancy University Hospital, Nancy, France

14 Research Division for Mental Health, University for Medical Information Technology (UMIT), Hall in Tirol, Austria

15 Department of Psychiatry, Centre Hospitalo-Universitaire de Nancy, Université ed Lorraine, Nancy, France

16 Semmelweis University, School of Ph.D. Studies, Budapest, Hungary

17 Slovene Center for Suicide Research, UP IAM, University of Primorska, Koper, Slovenia

18 Clinical Ethics Support & Accompanying Research, University Hospital Basel, Basel, Switzerland

19 Psychiatric Clinics of the University Basel, IBMB, University of Basel, Basel, Switzerland

20 Estonian-Swedish Mental Health & Suicidology Institute, Ctr. Behav. & Hlth. Sci, Tallinn University, Tallinn, Estonia

21 Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, USA

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BMC Public Health 2013, 13:479  doi:10.1186/1471-2458-13-479

Published: 16 May 2013

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.

Trial registration

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

Keywords:
SEYLE; Mental Health Promotion; Suicide prevention; Promotion; Well-being; Adolescents; Schools; RCT; Intervention; ProfScreen; QPR; Awareness