title: Trial for the Prevention of Depression (TriPoD) in final-year secondary students: study protocol for a cluster randomised controlled trial.
abstract: BACKGROUND
  Evidence suggests that current treatments cannot fully alleviate the burden of disease associated with depression but that prevention approaches offer a promising opportunity to further reduce this burden. Adolescence is a critical period in the development of mental illness, and final school examinations are a significant and nearly universal stressor that may act as a trigger for mental health difficulties such as depression. The aim of the present trial is to investigate the impact of SPARX-R, an online, gamified intervention based on cognitive behavioural principles, on the prevention of depression in secondary school students before their final examinations.
  
  
  METHODS
  Government, independent and Catholic secondary schools in New South Wales, Australia, will be recruited to participate in the trial. All students enrolled in their final year of high school (year 12) in participating schools will be invited to participate. To account for possible attrition, the target sample size was set at 1600 participants across 30 schools. Participating schools will be cluster randomised at the school level to receive either SPARX-R or lifeSTYLE, an attention-controlled placebo comparator. The control intervention is an online program aimed at maintaining a healthy lifestyle. The primary outcome will be symptoms of depression, and secondary outcomes will include symptoms of anxiety, suicidal ideation and behaviours, stigma and academic performance. Additional measures of cost-effectiveness, as well as process variables (e.g., adherence, acceptability) and potential predictors of response to treatment, will be collected. Consenting parents will be invited to complete measures regarding their own mental health and expectations for their child. Assessments will be conducted pre- and post-intervention and at 6- and 18-month follow-up. Primary analyses will compare changes in levels of depressive symptomatology for the intervention group relative to the attention control condition using mixed-effects model repeated-measures analyses to account for clustering within schools.
  
  
  CONCLUSIONS
  This is the first trial of a universal depression prevention intervention delivered to school students in advance of a specific, significant stressor. If found to be effective, this program may offer schools a new approach to preparing students for their final year of schooling.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry identifier: ACTRN12614000316606 . Registered 25 March 2014.
authors.affiliation: Black Dog Institute, University of New South Wales, Hospital Road, Randwick, Sydney, NSW, 2031, Australia. yael.perry@blackdog.org.au.
authors.forename: Yael
authors.initials: Y
authors.lastname: Perry
authors.affiliation: National Institute for Mental Health Research, The Australian National University, Canberra, Australia. alison.calear@anu.edu.au.
authors.forename: Alison L
authors.initials: AL
authors.lastname: Calear
authors.affiliation: Orygen, The National Centre of Excellence in Youth Mental Health, The University of Melbourne, Melbourne, Australia. andrew.mackinnon@unimelb.edu.au.
authors.forename: Andrew
authors.initials: A
authors.lastname: Mackinnon
authors.affiliation: National Institute for Mental Health Research, The Australian National University, Canberra, Australia. philip.batterham@anu.edu.au.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Batterham
authors.affiliation: South Australian Health and Medical Research Institute, Adelaide, Australia. julio.licinio@flinders.edu.au.
authors.forename: Julio
authors.initials: J
authors.lastname: Licinio
authors.affiliation: Black Dog Institute, University of New South Wales, Hospital Road, Randwick, Sydney, NSW, 2031, Australia. c.king@blackdog.org.au.
authors.forename: Catherine
authors.initials: C
authors.lastname: King
authors.affiliation: Black Dog Institute, University of New South Wales, Hospital Road, Randwick, Sydney, NSW, 2031, Australia. noel.thomsen@bigpond.com.
authors.forename: Noel
authors.initials: N
authors.lastname: Thomsen
authors.affiliation: Academic Psychiatry, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK. jan.scott@newcastle.ac.uk.
authors.forename: Jan
authors.initials: J
authors.lastname: Scott
authors.affiliation: Department of Clinical Psychology, VU University, Amsterdam, The Netherlands. t.donker@vu.nl.
authors.forename: Tara
authors.initials: T
authors.lastname: Donker
authors.affiliation: Department of Psychological Medicine, University of Auckland, Auckland, New Zealand. s.merry@auckland.ac.nz.
authors.forename: Sally
authors.initials: S
authors.lastname: Merry
authors.affiliation: Department of Psychological Medicine, University of Auckland, Auckland, New Zealand. t.fleming@auckland.ac.nz.
authors.forename: Theresa
authors.initials: T
authors.lastname: Fleming
authors.affiliation: Department of Psychological Medicine, University of Auckland, Auckland, New Zealand. k.stasiak@auckland.ac.nz.
authors.forename: Karolina
authors.initials: K
authors.lastname: Stasiak
authors.affiliation: Black Dog Institute, University of New South Wales, Hospital Road, Randwick, Sydney, NSW, 2031, Australia. a.werner-seidler@blackdog.org.au.
authors.forename: Aliza
authors.initials: A
authors.lastname: Werner-Seidler
authors.affiliation: Black Dog Institute, University of New South Wales, Hospital Road, Randwick, Sydney, NSW, 2031, Australia. h.christensen@blackdog.org.au.
authors.forename: Helen
authors.initials: H
authors.lastname: Christensen
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D000367:Age Factors; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003863:Depression / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control* / Q000523:psychology; D004521:Educational Measurement; D004522:Educational Status; D005260:Female; D006801:Humans; D008297:Male; D008605:Mental Health Services; D009517:New South Wales; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D012307:Risk Factors; D012572:School Health Services; D013334:Students / Q000523:psychology*; D013813:Therapy, Computer-Assisted / Q000379:methods; D013997:Time Factors