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Trial registered on ANZCTR


Registration number
ACTRN12614000316606
Ethics application status
Approved
Date submitted
17/03/2014
Date registered
25/03/2014
Date last updated
6/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
TriPoD: Trial for the Prevention of Depression in final year secondary school students
Scientific title
A randomised controlled trial to investigate the effects of SPARX, an online cognitive behavioural intervention, on the prevention of depression, anxiety and suicide risk in final year high school students.
Secondary ID [1] 284278 0
Nil known
Universal Trial Number (UTN)
U1111-1154-5917
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 291413 0
Anxiety 291414 0
Suicidal ideation and behaviour 291415 0
Condition category
Condition code
Mental Health 291774 291774 0 0
Depression
Mental Health 291775 291775 0 0
Anxiety
Mental Health 291776 291776 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group will participate in the SPARX program, an online, interactive, fantasy game based on principles of cognitive behavioural therapy (CBT), designed to prevent and treat depression in young people. The gaming component allows the participant to choose an avatar and then undertake a number of skill-building challenges in the context of a fantasy world. This component is supplemented by direct instruction, education and activities (or homework) provided by a ‘guide’ avatar. SPARX consists of seven modules (levels) which cover: finding hope, being active, dealing with emotions, problem solving, recognizing and challenging unhelpful thought and bringing it altogether. SPARX is delivered via the internet in school classrooms over the course of 5 weeks. Participants spend approximately 30-40 mins on the program per week.
Intervention code [1] 288993 0
Prevention
Comparator / control treatment
The control group will be allocated to the lifeSTYLE program, an attention match control condition. This program requires participants to complete online open ended questions that probe health factors, physical and artistic activities, education and hobbies, social, financial, and family roles, work habits and stress, medications, pain and nutrition. Each week it provides an online ‘package’ of educational material with information about health risks, in order to match levels of interactivity. lifeSTYLE is also delivered via the internet in school classrooms over the course of 5 weeks. Participants spend approximately 30-40 mins on the program per week. A previous trial demonstrated no difference in preference for this form of control condition relative to an active website arm.
Control group
Active

Outcomes
Primary outcome [1] 291705 0
Depressive symptoms, measured by mean score on the Major Depression Inventory (MDI)
Timepoint [1] 291705 0
Pre- and post-intervention, 6 and 18 month follow-up
Secondary outcome [1] 307328 0
Academic performance measured by an estimate of the Australian Tertiary Admission Rank (based on Higher School Certificate results provided to schools)
Timepoint [1] 307328 0
HSC results released in December (between 6 and 18 month follow-up)
Secondary outcome [2] 307329 0
Mean score on the Depression Anxiety Stress Scales - Anxiety subscale
Timepoint [2] 307329 0
Pre- and post-intervention, 6 and 18 month follow-up
Secondary outcome [3] 307330 0
Suicidal ideation and behaviour, as measured by total score on the Youth Risk Behavior Survey (YRBS)
Timepoint [3] 307330 0
Pre- and post-intervention, 6 and 18 month follow-up
Secondary outcome [4] 315477 0
Stigma measured by the Personal subscale of the Depression Stigma Scale
Timepoint [4] 315477 0
Pre- and post-intervention and 6 and 18 month follow up

Eligibility
Key inclusion criteria
Students in their final year of high school at participating schools. Students and their parents must provide consent to participate.
Minimum age
15 Years
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
A total of 1600 students will be recruited for this trial. In community samples, between 8 and 20% of young people will develop depression over an 18 month period and the rates of conversion to Major Depressive Disorder (MDD) are even higher in individuals who have sub-threshold symptoms. Power will be achieved primarily by recruiting a sample from mid to late adolescence where conversion rates are high (up to 15%), and undertaking the intervention in anticipation of a universal stressor. Calculations of required sample size were based on detecting a post-intervention effect size of 0.20 for the primary outcome measure. This is a small effect but reflects the universal nature of this intervention. Power was set at .80, a = .05 (two-tailed) and correlation of .5 assumed between baseline and endpoint scores. To allow for possible clustering effects (participants from the same school having characteristics and outcomes more alike than between schools) a design effect was calculated assuming an intraclass correlation (ICC) of 0.02 and an average class size of 25. The estimate of the ICC was derived from previous Australian school-based studies that have found non-significant class effects (i.e., non- significant intraclass correlation) and a value of .02. The estimated sample size was 1166. To accommodate an attrition or non-return of endpoint data rate of approximately 20%, (our previous school based trials reported 84%-88% completion at post-test, and 81% at 6 months) we set the target sample size at 1600, or 800 students (approximately 60 classes of 25) per condition. Power calculations for these are sufficient to examine all other secondary outcome effects with the exception of incidence/recurrence of MDD. Analysis of predictors will involve correlations. No mediation or moderation analyses are claimed, so power is also sufficient.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288906 0
Government body
Name [1] 288906 0
National Health and Medical Research Council
Address [1] 288906 0
GPO Box 1421
Canberra ACT 2601
Country [1] 288906 0
Australia
Primary sponsor type
Individual
Name
Prof Helen Christensen
Address
Black Dog Institute
University of New South Wales
Hospital Road
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 287601 0
None
Name [1] 287601 0
Address [1] 287601 0
Country [1] 287601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290736 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 290736 0
University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 290736 0
Australia
Date submitted for ethics approval [1] 290736 0
28/03/2014
Approval date [1] 290736 0
06/05/2014
Ethics approval number [1] 290736 0
HC14105
Ethics committee name [2] 293063 0
NSW Department of Education, State Education Research Approval Process (SERAP
Ethics committee address [2] 293063 0
Level 1, 1 Oxford Street, Darlinghurst 2010
Locked Bag 53, Darlinghurst NSW 1300
Ethics committee country [2] 293063 0
Australia
Date submitted for ethics approval [2] 293063 0
11/04/2014
Approval date [2] 293063 0
18/06/2014
Ethics approval number [2] 293063 0
SERAP2014001

Summary
Brief summary
Using Randomised Controlled Trial methodology, this study investigates the effectiveness of a universal prevention intervention for depression in adolescents prior to the Higher School Certificate (HSC). Students in 30 schools across New South Wales (NSW) will be randomly allocated to receive an online, automated, preventative Cognitive Behavioral Therapy (CBT) program or an online control program focused on health and wellbeing. Students will participate in the intervention in February of Year 12, and will complete assessment measures pre- and post-intervention, approximately 6 months later (prior to the Trial HSC) and at 18-month follow-up. The primary outcome measure will be symptom levels of depression. Secondary outcomes include academic performance, incidence/recurrence of depression, suicidal ideation and behaviour. Cost effectiveness, as well as predictors of treatment response and adherence will also be measured. Additionally, the effect of the intervention on parental mental health and wellbeing will be examined.
Trial website
Trial related presentations / publications
Public notes
The manuscript reporting the outcomes from this paper is currently under review and the anticipated publication date is in the latter part of 2017.

Contacts
Principal investigator
Name 47002 0
Prof Helen Christensen
Address 47002 0
Black Dog Institute
Hospital Rd Randwick
NSW 2031
Country 47002 0
Australia
Phone 47002 0
+61 2 9382 4530
Fax 47002 0
Email 47002 0
h.christensen@blackdog.org.au
Contact person for public queries
Name 47003 0
Dr Aliza Werner-Seidler
Address 47003 0
Black Dog Institute
Hospital Rd Randwick
NSW 2031
Country 47003 0
Australia
Phone 47003 0
+61 2 9382 3769
Fax 47003 0
Email 47003 0
a.werner-seidler@blackdog.org.au
Contact person for scientific queries
Name 47004 0
Dr Aliza Werner-Seidler
Address 47004 0
Black Dog Institute
Hospital Rd Randwick
NSW 2031
Country 47004 0
Australia
Phone 47004 0
+61 2 9382 3769
Fax 47004 0
Email 47004 0
a.werner-seidler@blackdog.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary