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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Trial for the Prevention of Depression (TriPoD) in final-year secondary students: study protocol for a cluster randomised controlled trial

Authors: Yael Perry, Alison L. Calear, Andrew Mackinnon, Philip J. Batterham, Julio Licinio, Catherine King, Noel Thomsen, Jan Scott, Tara Donker, Sally Merry, Theresa Fleming, Karolina Stasiak, Aliza Werner-Seidler, Helen Christensen

Published in: Trials | Issue 1/2015

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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/Design

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.

Discussion

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.

Trial registration

Australian New Zealand Clinical Trials Registry identifier: ACTRN12614000316​606. Registered 25 March 2014.
Appendix
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Metadata
Title
Trial for the Prevention of Depression (TriPoD) in final-year secondary students: study protocol for a cluster randomised controlled trial
Authors
Yael Perry
Alison L. Calear
Andrew Mackinnon
Philip J. Batterham
Julio Licinio
Catherine King
Noel Thomsen
Jan Scott
Tara Donker
Sally Merry
Theresa Fleming
Karolina Stasiak
Aliza Werner-Seidler
Helen Christensen
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0929-1

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