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

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).

Hours of sleep in adolescents and its association with anxiety, emotional concerns, and suicidal ideation.

OBJECTIVES: Anxiety and concerns in daily life may result in sleep problems and consistent evidence suggests that inadequate sleep has several negative consequences on cognitive performance, physical activity, and health. The aim of our study was to evaluate the association between mean hours of sleep per night, psychologic distress, and behavioral concerns. METHODS: A cross-sectional analysis of the correlation between the number of hours of sleep per night and the Zung Self-rating Anxiety Scale (Z-SAS), the Paykel Suicidal Scale (PSS), and the Strengths and Difficulties Questionnaire (SDQ), was performed on 11,788 pupils (mean age±standard deviation [SD], 14.9±0.9; 55.8% girls) from 11 different European countries enrolled in the SEYLE (Saving and Empowering Young Lives in Europe) project. RESULTS: The mean number of reported hours of sleep per night during school days was 7.7 (SD, ±1.3), with moderate differences across countries (r=0.06; P<.001). A reduced number of sleeping hours (less than the average) was more common in girls (ß=0.10 controlling for age) and older pupils (ß=0.10 controlling for sex). Reduced sleep was found to be associated with increased scores on SDQ subscales of emotional (ß=-0.13) and peer-related problems (ß=-0.06), conduct (ß=-0.07), total SDQ score (ß=-0.07), anxiety (Z-SAS scores, ß=-10), and suicidal ideation (PSS, ß=-0.16). In a multivariate model including all significant variables, older age, emotional and peer-related problems, and suicidal ideation were the variables most strongly associated with reduced sleep hours, though female gender, conduct problems measured by the SDQ, and anxiety only showed modest effects (ß=0.03-0.04). CONCLUSIONS: Our study supports evidence that reduced hours of sleep are associated with potentially severe mental health problems in adolescents. Because sleep problems are common among adolescents partly due to maturational processes and changes in sleep patterns, parents, other adults, and adolescents should pay more attention to their sleep patterns and implement interventions, if needed.