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

BMC Public Health

Christina W Hoven^1,10  Airi Varnik^1,16  Peeter Varnik¹  Pilar Saiz^1,13  Stella Reiter-Theil²  Vita Postuvan^1,11  Bogdan Nemes⁴  George Musa^1,10  Ursa Mars^1,11  Miriam Iosue^1,14  Agnes Keresztény⁷  Helen Keeley⁸  Jean Pierre Kahn⁵  Michael Kaess³  Christian Haring^1,12  Francis Guillemin⁶  Doina Cosman⁴  Paul Corcoran⁸  Romuald Brunner³  Julio Bobes^1,13  Judit Balazs⁷  Alan Apter⁹  Marco Sarchiapone^1,14  Danuta Wasserman^1,15  Camilla Wasserman^1,14  Vladimir Carli^1,15 

[1] Estonian-Swedish Mental Health & Suicidology Institute, Ctr. Behav. & Hlth. Sci, Tallinn University, Tallinn, Estonia;Psychiatric Clinics of the University Basel, IBMB, University of Basel, Basel, Switzerland;Section for Disorders of Personality Development, Clinic of Child and Adolescent Psychiatry, Heidelberg, Germany;Clinical Psychology Department, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania;Department of Psychiatry, Centre Hospitalo-Universitaire de Nancy, Université ed Lorraine, Nancy, France;Inserm CIC-EC, Nancy University Hospital, Nancy, France;Institute of Psychology, Eötvös Loránd University, Budapest, Hungary;National Suicide Research Foundation, Cork, Ireland;Feinberg Child Study Centre, Schneider Children’s Medical Centre, Tel Aviv University, Tel Aviv, Israel;Department of Child and Adolescent Psychiatry, Columbia University-New York State Psychiatric Institute, New York, USA;Slovene Center for Suicide Research, UP IAM, University of Primorska, Koper, Slovenia;Research Division for Mental Health, University for Medical Information Technology (UMIT), Hall in Tirol, Austria;Department of Psychiatry, University of Oviedo, Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM, Oviedo, Spain;Department of Health Sciences, University of Molise, Campobasso, Italy;WHO Collaborating Center for Research, Methods Development and Training in Suicide Prevention, Stockholm, Sweden;Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, USA

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

Others  :  1162202
DOI  :  10.1186/1471-2458-13-479

 received in 2012-07-11, accepted in 2013-05-11,  发布年份 2013

【 摘 要 】

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).

【 授权许可】

   
2013 Carli et al.; licensee BioMed Central Ltd.

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