title: Healthy Learning Mind - a school-based mindfulness and relaxation program: a study protocol for a cluster randomized controlled trial.
abstract: BACKGROUND
  Mindfulness has shown positive effects on mental health, mental capacity and well-being among adult population. Among children and adolescents, previous research on the effectiveness of mindfulness interventions on health and well-being has shown promising results, but studies with methodologically sound designs have been called for. Few intervention studies in this population have compared the effectiveness of mindfulness programs to alternative intervention programs with adequate sample sizes.
  
  
  METHODS
  Our primary aim is to explore the effectiveness of a school-based mindfulness intervention program compared to a standard relaxation program among a non-clinical children and adolescent sample, and a non-treatment control group in school context. In this study, we systematically examine the effects of mindfulness intervention on mental well-being (primary outcomes being resilience; existence/absence of depressive symptoms; experienced psychological strengths and difficulties), cognitive functions, psychophysiological responses, academic achievements, and motivational determinants of practicing mindfulness. The design is a cluster randomized controlled trial with three arms (mindfulness intervention group, active control group, non-treatment group) and the sample includes 59 Finnish schools and approx. 3 000 students aged 12-15 years. Intervention consists of nine mindfulness based lessons, 45 mins per week, for 9 weeks, the dose being identical in active control group receiving standard relaxation program called Relax. The programs are delivered by 14 educated facilitators. Students, their teachers and parents will fill-in the research questionnaires before and after the intervention, and they will all be followed up 6 months after baseline. Additionally, students will be followed 12 months after baseline. For longer follow-up, consent to linking the data to the main health registers has been asked from students and their parents.
  
  
  CONCLUSIONS
  The present study examines systematically the effectiveness of a school-based mindfulness program compared to a standard relaxation program, and a non-treatment control group. A strength of the current study lies in its methodologically rigorous, randomized controlled study design, which allows novel evidence on the effectiveness of mindfulness over and above a standard relaxation program.
  
  
  BACKGROUND
  ISRCTN18642659 . Retrospectively registered 13 October 2015.
authors.affiliation: Folkhälsan Research Center, Topeliuksenkatu 20, 00250, Helsinki, Finland. salla-maarit.volanen@helsinki.fi.|Department of Public Health, University of Helsinki, Helsinki, Finland. salla-maarit.volanen@helsinki.fi.
authors.forename: Salla-Maarit
authors.identifier: http://orcid.org/0000-0002-4436-9518
authors.initials: SM
authors.lastname: Volanen
authors.affiliation: Institute of Behavioural Sciences, University of Helsinki, Helsinki, Finland.
authors.forename: Maarit
authors.initials: M
authors.lastname: Lassander
authors.affiliation: School of Social Sciences and Humanities, University of Tampere, Tampere, Finland.
authors.forename: Nelli
authors.initials: N
authors.lastname: Hankonen
authors.affiliation: National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Päivi
authors.initials: P
authors.lastname: Santalahti
authors.affiliation: Unit of Psychology, University of Oulu, Oulu, Finland.
authors.forename: Mirka
authors.initials: M
authors.lastname: Hintsanen
authors.affiliation: Folkhälsan Research Center, Topeliuksenkatu 20, 00250, Helsinki, Finland.|Department of Public Health, University of Helsinki, Helsinki, Finland.
authors.forename: Nina
authors.initials: N
authors.lastname: Simonsen
authors.affiliation: Department of Public Health, University of Helsinki, Helsinki, Finland.|Department of Adolescent Psychiatry, Helsinki University Central Hospital, Helsinki, Finland.|Department of Mental Health and Substance Abuse Services, National Institute for Health and Welfare, Helsinki, Finland.
authors.forename: Anu
authors.initials: A
authors.lastname: Raevuori
authors.affiliation: Institute of Behavioural Sciences, University of Helsinki, Helsinki, Finland.|Department of Teacher Education, University of Helsinki, Helsinki, Finland.
authors.forename: Sari
authors.initials: S
authors.lastname: Mullola
authors.affiliation: Department of Biostatistics, University of Turku, Turku, Finland.
authors.forename: Tero
authors.initials: T
authors.lastname: Vahlberg
authors.affiliation: Department of Public Health, University of Helsinki, Helsinki, Finland.
authors.forename: Anna
authors.initials: A
authors.lastname: But
authors.affiliation: Folkhälsan Research Center, Topeliuksenkatu 20, 00250, Helsinki, Finland.|Department of Public Health, University of Skövde, Skövde, Sweden.|Department of Public Health, University of Turku, Turku, Finland.
authors.forename: Sakari
authors.initials: S
authors.lastname: Suominen
mesh_terms: D000293:Adolescent; D002648:Child; D005260:Female; D005387:Finland; D006801:Humans; D008297:Male; D008603:Mental Health; D064866:Mindfulness / Q000379:methods*; D015397:Program Evaluation; D012064:Relaxation Therapy / Q000379:methods*; D012572:School Health Services; D013334:Students / Q000523:psychology; D011795:Surveys and Questionnaires
keywords: Children and adolescents; Health promotion; Mental health; Mindfulness; School-based intervention; Well-being