title: Effectiveness and micro-costing of the KiVa school-based bullying prevention programme in Wales: study protocol for a pragmatic definitive parallel group cluster randomised controlled trial.
abstract: BACKGROUND
  Bullying refers to verbal, physical or psychological aggression repeated over time that is intended to cause harm or distress to the victims who are unable to defend themselves. It is a key public health priority owing to its widespread prevalence in schools and harmful short- and long-term effects on victims' well-being. There is a need to strengthen the evidence base by testing innovative approaches to preventing bullying. KiVa is a school-based bullying prevention programme with universal and indicated elements and an emphasis on changing bystander behaviour. It achieved promising results in a large trial in Finland, and now requires testing in other countries. This paper describes the protocol for a cluster randomised controlled trial (RCT) of KiVa in Wales.
  
  
  METHODS
  The study uses a two-arm waitlist control pragmatic definitive parallel group cluster RCT design with an embedded process evaluation and calculation of unit cost. Participating schools will be randomised a using a 1:1 ratio to KiVa plus usual provision (intervention group) or usual provision only (control group). The trial has one primary outcome, child self-reported victimisation from bullying, dichotomised as 'victimised' (bullied at least twice a month in the last couple of months) versus 'not victimised'. Secondary outcomes are: bullying perpetration; aspects of child social and emotional well-being (including emotional problems, conduct, peer relations, prosocial behaviour); and school attendance. Follow-up is at 12 months post-baseline. Implementation fidelity is measured through teacher-completed lesson records and independent school-wide observation. A micro-costing analysis will determine the costs of implementing KiVa, including recurrent and non-recurrent unit costs. Factors related to the scalability of the programme will be examined in interviews with head teachers and focus groups with key stakeholders in the implementation of school-based bullying interventions.
  
  
  CONCLUSIONS
  The results from this trial will provide evidence on whether the KiVa programme is transportable from Finland to Wales in terms of effectiveness and implementation. It will provide information about the costs of delivery and generate insights into factors related to the scalability of the programme.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN23999021 Date 10-6-13.
authors.affiliation: Centre for Evidence Based Early Intervention, School of Psychology, College of Health and Behavioural Sciences, Bangor University, Nantlle Building, Normal Site, Bangor, Gwynedd, LL57 2PX, Wales, United Kingdom. s.clarkson@bangor.ac.uk.
authors.forename: Suzy
authors.initials: S
authors.lastname: Clarkson
authors.affiliation: Dartington Social Research Unit, Lower Hood Barn, Dartington, TQ9 6AB, Devon, United Kingdom. nick.axford@dartington.org.uk.
authors.forename: Nick
authors.initials: N
authors.lastname: Axford
authors.affiliation: NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter, Exeter, Devon, EX1 2 LU, United Kingdom. v.berry@exeter.ac.uk.
authors.forename: Vashti
authors.initials: V
authors.lastname: Berry
authors.affiliation: Centre for Health Economics and Medicines Evaluation, Bangor University, Ardudwy Hall, Bangor, Gwynedd, LL57 2PZ, Wales, United Kingdom. r.t.edwards@bangor.ac.uk.
authors.forename: Rhiannon Tudor
authors.initials: RT
authors.lastname: Edwards
authors.affiliation: Dartington Social Research Unit, Lower Hood Barn, Dartington, TQ9 6AB, Devon, United Kingdom. gretchen.bjornstad@dartington.org.uk.
authors.forename: Gretchen
authors.initials: G
authors.lastname: Bjornstad
authors.affiliation: Dartington Social Research Unit, Lower Hood Barn, Dartington, TQ9 6AB, Devon, United Kingdom. zoe.wrigley@dartington.org.uk.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Wrigley
authors.affiliation: Centre for Health Economics and Medicines Evaluation, Bangor University, Ardudwy Hall, Bangor, Gwynedd, LL57 2PZ, Wales, United Kingdom. j.charles@bangor.ac.uk.
authors.forename: Joanna
authors.initials: J
authors.lastname: Charles
authors.affiliation: NWORTH CTU - North Wales Organisation for Randomised Trials in Health, Bangor University, Y Wern, Normal Site, Holyhead Road, Bangor, Gwynedd, LL57 2PZ, Wales, United Kingdom. z.hoare@bangor.ac.uk.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Hoare
authors.affiliation: NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter, Exeter, Devon, EX1 2 LU, United Kingdom. o.c.ukoumunne@exeter.ac.uk.
authors.forename: Obioha C
authors.initials: OC
authors.lastname: Ukoumunne
authors.affiliation: NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter, Exeter, Devon, EX1 2 LU, United Kingdom. j.n.matthews@exeter.ac.uk.
authors.forename: Justin
authors.initials: J
authors.lastname: Matthews
authors.affiliation: Centre for Evidence Based Early Intervention, School of Psychology, College of Health and Behavioural Sciences, Bangor University, Nantlle Building, Normal Site, Bangor, Gwynedd, LL57 2PX, Wales, United Kingdom. j.hutchings@bangor.ac.uk.
authors.forename: Judy
authors.initials: J
authors.lastname: Hutchings
mesh_terms: D058445:Bullying / Q000517:prevention & control*; D002648:Child; D002675:Child, Preschool; D003142:Communication; D019548:Crime Victims / Q000523:psychology / Q000706:statistics & numerical data; D005387:Finland; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D008603:Mental Health; D011340:Problem Solving; D012107:Research Design; D012572:School Health Services / Q000191:economics / Q000458:organization & administration*; D014852:Wales
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