title: Linked randomised controlled trials of face-to-face and electronic brief intervention methods to prevent alcohol related harm in young people aged 14-17 years presenting to Emergency Departments (SIPS junior).
abstract: BACKGROUND
  Alcohol is a major global threat to public health. Although the main burden of chronic alcohol-related disease is in adults, its foundations often lie in adolescence. Alcohol consumption and related harm increase steeply from the age of 12 until 20 years. Several trials focusing upon young people have reported significant positive effects of brief interventions on a range of alcohol consumption outcomes. A recent review of reviews also suggests that electronic brief interventions (eBIs) using internet and smartphone technologies may markedly reduce alcohol consumption compared with minimal or no intervention controls. Interventions that target non-drinking youth are known to delay the onset of drinking behaviours. Web based alcohol interventions for adolescents also demonstrate significantly greater reductions in consumption and harm among 'high-risk' drinkers; however changes in risk status at follow-up for non-drinkers or low-risk drinkers have not been assessed in controlled trials of brief alcohol interventions.
  
  
  METHODS
  The study design comprises two linked randomised controlled trials to evaluate the effectiveness and cost-effectiveness of two intervention strategies compared with screening alone. One trial will focus on high-risk adolescent drinkers attending Emergency Departments (Eds) and the other will focus on those identified as low-risk drinkers or abstinent from alcohol but attending the same ED. Our primary (null) hypothesis is similar for both trials: Personalised Feedback and Brief Advice (PFBA) and Personalised Feedback plus electronic Brief Intervention (eBI) are no more effective than screening alone in alcohol consumed at 12 months after randomisation as measured by the Time-Line Follow-Back 28-day version. Our secondary (null) hypothesis relating to economics states that PFBA and eBI are no more cost-effective than screening alone. In total 1,500 participants will be recruited into the trials, 750 high-risk drinkers and 750 low-risk drinkers or abstainers. Participants will be randomised with equal probability, stratified by centre, to either a screening only control group or one of the two interventions: single session of PFBA or eBI. All participants will be eligible to receive treatment as usual in addition to any trial intervention. Individual participants will be followed up at 6 and 12 months after randomisation.
  
  
  CONCLUSIONS
  The protocol represents an ambitious innovative programme of work addressing alcohol use in the adolescent population.
  
  
  BACKGROUND
  ISRCTN45300218. Registered 5th July 2014.
authors.affiliation: Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. Paolo.Deluca@kcl.ac.uk.
authors.forename: Paolo
authors.initials: P
authors.lastname: Deluca
authors.affiliation: Centre for Health Services Studies, University of Kent, Canterbury, UK. S.Coulton@kent.ac.uk.
authors.forename: Simon
authors.initials: S
authors.lastname: Coulton
authors.affiliation: Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, Wales, UK. f.alam@swansea.ac.uk.
authors.forename: M Fasihul
authors.initials: MF
authors.lastname: Alam
authors.affiliation: Health Economics and Policy Research Unit, University of South Wales, Pontypridd, UK. professorcohen@outlook.com.
authors.forename: David
authors.initials: D
authors.lastname: Cohen
authors.affiliation: Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. kim.donoghue@kcl.ac.uk.
authors.forename: Kim
authors.initials: K
authors.lastname: Donoghue
authors.affiliation: Northumberland Tyne and Wear NHS Foundation Trust, Newcastle, UK. Eilish.Gilvarry@ntw.nhs.uk.
authors.forename: Eilish
authors.initials: E
authors.lastname: Gilvarry
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle, UK. eileen.kaner@newcastle.ac.uk.
authors.forename: Eileen
authors.initials: E
authors.lastname: Kaner
authors.affiliation: Paediatric Emergency Medicine, Imperial College, London, UK. i.maconochie@imperial.ac.uk.
authors.forename: Ian
authors.initials: I
authors.lastname: Maconochie
authors.affiliation: Northumberland Tyne and Wear NHS Foundation Trust, Newcastle, UK. Paul.McArdle@ntw.nhs.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: McArdle
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle, UK. r.mcgovern@newcastle.ac.uk.
authors.forename: Ruth
authors.initials: R
authors.lastname: McGovern
authors.affiliation: School of Health and Social Care, Teesside University, Middlesbrough, UK. D.Newbury-Birch@tees.ac.uk.
authors.forename: Dorothy
authors.initials: D
authors.lastname: Newbury-Birch
authors.affiliation: School of Psychology, University of Surrey, Guildford, UK. r.patton@surrey.ac.uk.
authors.forename: Robert
authors.initials: R
authors.lastname: Patton
authors.affiliation: Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea, Wales, UK. c.j.phillips@swansea.ac.uk.
authors.forename: Ceri
authors.initials: C
authors.lastname: Phillips
authors.affiliation: Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. thomas.phillips@kcl.ac.uk.|Humber NHS Foundation Trust, Willerby, UK. thomas.phillips@kcl.ac.uk.
authors.forename: Thomas
authors.initials: T
authors.lastname: Phillips
authors.affiliation: College of Medicine, Swansea University, Swansea, Wales, UK. i.t.russell@swansea.ac.uk.
authors.forename: Ian
authors.initials: I
authors.lastname: Russell
authors.affiliation: Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. john.strang@kcl.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Strang
authors.affiliation: Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK. Colin.Drummond@kcl.ac.uk.
authors.forename: Colin
authors.initials: C
authors.lastname: Drummond
mesh_terms: D000293:Adolescent; D000328:Adult; D019973:Alcohol-Related Disorders / Q000191:economics / Q000517:prevention & control* / Q000628:therapy*; D000435:Alcoholic Intoxication / Q000517:prevention & control / Q000628:therapy; D003362:Cost-Benefit Analysis; D003376:Counseling; D004636:Emergency Service, Hospital / Q000191:economics / Q000458:organization & administration*; D005246:Feedback; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D012107:Research Design; D055815:Young Adult