The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics

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dc.contributor.authorCarli, Vladimir
dc.contributor.authorWasserman, C.
dc.contributor.authorWasserman, D.
dc.contributor.authorSarchiapone, Marco
dc.contributor.authorApter, Alan
dc.contributor.authorBalazs, Judit
dc.contributor.authorBobes, Julio
dc.contributor.authorBrunner, Romuald
dc.contributor.authorCorcoran, Paul
dc.contributor.authorCosman, Doina
dc.contributor.authorGuillemin, F.
dc.contributor.authorHaring, C.
dc.contributor.authorKaess, M.
dc.contributor.authorKahn, J. P.
dc.contributor.authorKeeley, Helen S.
dc.contributor.authorKereszteny, A.
dc.contributor.authorIosue, M.
dc.contributor.authorMars, U.
dc.contributor.authorMusa, G.
dc.contributor.authorNemes, B.
dc.contributor.authorPostuvan, V.
dc.contributor.authorReiter-Theil, S.
dc.contributor.authorSaiz, P.
dc.contributor.authorVarnik, P.
dc.contributor.authorVarnik, A.
dc.contributor.authorHoven, C. W.
dc.date.accessioned2014-01-08T16:37:20Z
dc.date.available2014-01-08T16:37:20Z
dc.date.issued2013-05-16
dc.date.updated2013-09-11T11:08:44Z
dc.description.abstractBACKGROUND: 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).en
dc.description.sponsorshipEuropean Commission (Coordination Theme 1 (Health) of the European Union Seventh Framework Program (FP7), HEALTH-F2-2009-223091)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationCarli 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, Keresztény A, Iosue M, Mars U, Musa G, Nemes B, Postuvan V, Reiter-Theil S, Saiz P, Varnik P, Varnik A, Hoven CW. (2013) 'The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics'. BMC Public Health, 13 :479. doi: 10.1186/1471-2458-13-479en
dc.identifier.doi10.1186/1471-2458-13-479
dc.identifier.issn1471-2458
dc.identifier.journaltitleBMC Public Healthen
dc.identifier.startpage479en
dc.identifier.urihttps://hdl.handle.net/10468/1297
dc.identifier.volume13en
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urihttp://www.biomedcentral.com/1471-2458/13/479
dc.rights© 2013 Carli et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.en
dc.rights.urihttp://creativecommons.org/licenses/by/2.0en
dc.subjectSEYLEen
dc.subjectMental health promotionen
dc.subjectSuicide preventionen
dc.subjectPromotionen
dc.subjectWell-beingen
dc.subjectAdolescentsen
dc.subjectSchoolsen
dc.subjectRCTen
dc.subjectInterventionen
dc.subjectProfScreenen
dc.subjectQPRen
dc.subjectAwarenessen
dc.titleThe saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristicsen
dc.typeArticle (peer-reviewed)en
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