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Trial registered on ANZCTR


Registration number
ACTRN12619000855123
Ethics application status
Approved
Date submitted
31/05/2019
Date registered
17/06/2019
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Future Proofing Study: A School-Based Depression Prevention Trial
Scientific title
A Cluster-Randomised, Two-Arm Parallel-Group Superiority Trial of the Effectiveness of Digital Interventions for Preventing Depression in Adolescents: The Future Proofing Study
Secondary ID [1] 298338 0
None
Universal Trial Number (UTN)
U1111-1234-1637
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 312984 0
Anxiety 312985 0
Insomnia
312986 0
Poor sleep 313243 0
Condition category
Condition code
Mental Health 311490 311490 0 0
Depression
Mental Health 311683 311683 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Future Proofing Study is a large school-based cluster randomised controlled trial testing whether depression can be prevented using a digital CBT apps in young people. Participating schools will be randomly allocated to one of two groups. One group will serve as the control group, and the other will be the intervention group and receive the SPARX CBT app.

This trial will combine a universal prevention intervention (Stage I; SPARX) with an indicated prevention intervention (Stage II; Sleep Ninja). The interventions will be delivered in two stages spaced 12 months apart. Both interventions will be delivered to Year 8 school students via smartphone apps designed to work with iPhone and Android operating systems. Apps will be available to install for free from the Apple App and Google Play Stores in Australia.

Stage I Intervention Name: SPARX

SPARX is a gaming treatment intervention, which was developed by researchers at the University of Auckland. SPARX was adapted by the research team from the treatment version to focus on the prevention of depression in young people. The program is based on CBT and delivered via smartphone app. CBT is the gold standard psychological intervention for the prevention and treatment of depression and involves developing skills to help cope with difficult or challenging situations. Skills learnt though the program include relaxation skills, emotion identification and management, behavioural activation (being active), recognising and challenging unhelpful thoughts, and practical problem solving. This intervention is delivered in a game format, where users move through an imaginary world developing psychological skills. 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, recognising and challenging unhelpful thoughts and bringing it altogether. Each module takes approximately 20 minutes to complete. Each module is designed to be completed on separate days, and users are encouraged to do between one to two modules per week.

SPARX will be accessible to all trial participants who are randomised to the intervention arm of the first stage of the trial. SPARX-FP will be installed onto participants’ own smartphones during a supervised classroom visit and completed in their own time during first 6 weeks of the trial. SPARX-FP will become active immediately following the baseline assessment. At the end of this 6-week period participants will lose access to the app. SPARX-FP will collect usage data while the app is active. This includes when and how many times users enter the app, how long they spend in the app, and how many modules they complete. It will be up to individuals how many modules they complete and whether or not they choose to finish the program.

Stage II Intervention Name: Sleep Ninja

Sleep Ninja will be delivered to a subset of participants from the Stage I intervention arm. Participants scoring equal to or greater than 10 on the PHQ-A at 12-month follow-up (indicating moderate depression, estimated at approximately 20% of sample) will receive an automated invitation to install the Sleep Ninja app onto their smartphones.

Sleep Ninja is a smartphone app based on Cognitive Behaviour Therapy for Insomnia (CBT-I), which is the gold standard, evidence-based treatment for insomnia. Sleep Ninja was developed and tested for acceptability in Australia (Werner-Seidler et al, 2017) and covers the following skills and strategies: psychoeducation, stimulus control, sleep-focused cognitive therapy, basic sleep hygiene and behavioural activation.

Sleep Ninja takes the form of a chat-bot. When the app is open, conversation messages appear on the phone screen from the Sleep Ninja (who acts as a sleep coach) and users interact with the Sleep Ninja by selecting from pre-determined responses, to which the Sleep Ninja is programmed to respond.

Users progress through six levels or “belts”, starting at a white belt and working their way through to black belt status. To level up and gain the next belt, users must complete within a 7-day period:
• one training session (which takes approximately 5-10 minutes); and
• at least three nights of sleep tracking using the app’s sleep diary.

At the completion of each level, users are provided with a brief report card summarising their self-reported sleep over that period. There are additional optional app features that users can access at their choosing, which include a meditation recording, extra sleep information, quick sleep tips and a ‘Get Help Now’ button that links directly to Australian crisis support services including Kids Helpline. If participants agree, the app sends a reminder each morning to enter sleep tracking from the night before, and a reminder an hour before bed to begin winding down in preparation for sleep.

Sleep Ninja will be available only to participants who meet inclusion criteria for the second stage of the trial following the 12-month follow-up assessment and who are randomised to receive the sleep intervention. Eligible participants are required to complete this component of the study, having opted in during the initial consent stage. However, they have the ability to choose not to install the app on their phones if they don't want to. Participants will complete the intervention during their own time. Depending on the frequency of use, participants can take as little as 18 days to progress to black belt status, however, regardless of progress, all participants will lose access to the app 6 weeks following randomisation. It will be up to the participant to decide how much of the program they complete. Adherence to the Sleep Ninja app will be monitored by the app which records app usage and module completion.
Intervention code [1] 314581 0
Prevention
Intervention code [2] 314582 0
Behaviour
Comparator / control treatment
An inactive control arm (no intervention) will be included at each intervention Stage. The choice to use a non-active comparator was made to avoid placing unnecessary burden on participants and schools.

All participants in both control and intervention arms complete all study surveys. Those who are identified to be at immediate risk of suicide or other harm based on study measures will be provided assistance from their school counsellor.
Control group
Active

Outcomes
Primary outcome [1] 320199 0
Depression
Assessed using the Patient Health Questionnaire for Adolescents (PHQ-A; Johnson, Harris, Spitzer, & Williams, 2002).
Timepoint [1] 320199 0
Measured at baseline, post-intervention, 6-, 12-, 24-, 36, 48 and 60 months post baseline, and post-intervention at Stage II. The primary timepoint is 12-months.
Secondary outcome [1] 370831 0
Psychological distress
Assessed using the Distress Questionnaire-5 (DQ-5; Batterham et al., 2016).
Timepoint [1] 370831 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [2] 370832 0
Anxiety
Assessed using the Spence Children's Anxiety Scale Short-Form; SCAS-SF plus the SCAS Generalized Anxiety and Social Phobia Subscales (Spence, Barrett, & Turner, 2003).
Timepoint [2] 370832 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline, and post-intervention at Stage II.
Secondary outcome [3] 370833 0
Insomnia
Assessed using the Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001).
Timepoint [3] 370833 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline, and post-intervention at Stage II.
Secondary outcome [4] 370834 0
Suicide (subsidiary outcome)
Assessed using the Suicidal Ideation Attributes Scale (SIDAS; van Spijker et al., 2014) and three items from the the Youth Risk Behaviour Scale (Brener et al., 2002), which assesses suicide-related behaviours in the past 12 months (thoughts, plans and attempts).
Timepoint [4] 370834 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [5] 370835 0
Externalising and emotional problems (subsidiary outcome)
Assessed using the Strengths and Difficulties Questionnaire
Timepoint [5] 370835 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [6] 370836 0
Eating disorders (subsidiary outcome)
Assessed using the The Screen for Eating Disorders (SDE; Maguen et al., 2018).
Timepoint [6] 370836 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [7] 370837 0
Self-harm (subsidiary outcome)
Assessed using the Self-Harm Questionnaire (SHQ; Ougrin & Boege, 2013).
Timepoint [7] 370837 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [8] 370838 0
Alcohol use (subsidiary outcome)
Assessed using the Alcohol Use Questionnaire. The Alcohol Use questionnaire included in this trial was developed by the National Drug and Alcohol Research Centre, UNSW. The questionnaire contains nine items assessing age of first use, and frequency and quantity of alcohol use.
Timepoint [8] 370838 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [9] 370839 0
Substance use (subsidiary outcome)
Assessed using the Substance Use Questionnaire which was adapted from the Australian Institute of Health and Welfare 2007 National Drug Strategy Household Survey. It contains five items assessing recency of substance use, with a specific focus on cannabis (additional items on age of first use and frequency of use).

Timepoint [9] 370839 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.

Secondary outcome [10] 370840 0
Psychosis (subsidiary outcome)
Assessed using three items from the Adolescent Psychotic-Like Symptom (APSS; Kelleher, Harley, Murtagh, & Cannon, 2011). The items administered assess paranoia, auditory and visual hallucinations.
Timepoint [10] 370840 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [11] 370841 0
Sleep quality (subsidiary outcome)
Assessed using the Pittsburgh Sleep Quality Index (PSQI; Buysse, Reynolds, Monk, Berman, & Kupfer, 1989).
Timepoint [11] 370841 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [12] 370842 0
Health-related quality of life and cost effectiveness (subsidiary outcome)
Assessed using the Child Health Utility 9D (CHU-9D; Stevens, 2009).
Timepoint [12] 370842 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [13] 370843 0
Wellbeing (subsidiary outcome)
Assessed using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS; Tennant et al., 2007).
Timepoint [13] 370843 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [14] 370844 0
Body mass index (subsidiary outcome)
Calculated using self-reported height (cm) and weight (kg).
Timepoint [14] 370844 0
Measured at baseline, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [15] 370845 0
Personality (subsidiary outcome)
Assessed using the The Big Five Personality Inventory (BFI-10; Rammstedt & John, 2007).
Timepoint [15] 370845 0
Measured at baseline only.
Secondary outcome [16] 370846 0
School connectedness (subsidiary outcome)
Assessed using the questionnaire items developed by the OECD Programme for International Student Assessment (OECD et al., 2004).
Timepoint [16] 370846 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [17] 370847 0
Social support (subsidiary outcome)
Assessed using the Schuster Social Support Scale (SSSS; Schuster, Kessler, & Aseltine, 1990).
Timepoint [17] 370847 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [18] 370848 0
Social media use (subsidiary outcome)
Assessed using the Maladaptive Facebook Usage Scale (Smith, Hames, & Joiner, 2013).
Timepoint [18] 370848 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [19] 370849 0
Gender identification (subsidiary outcome)
Assessed using two items developed for this study using forced choice questions where participants indicate their sex at birth (male/female) and current gender identity with all potential options available. There is a 'prefer not to answer' option for these items.
Timepoint [19] 370849 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [20] 370850 0
Sexual preferences (subsidiary outcome)
Assessed using two items developed for this study, where respondents indicate the gender/s they are attracted to and whether they consider themselves to be heterosexual, gay or lesbian, pansexual, bisexual, asexual or other.
Timepoint [20] 370850 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [21] 370851 0
Romantic relationships (subsidiary outcome)
Assessed using two items developed specifically for this study assessing the number of special or important romantic relationships in the past year, as well as the number of break-ups in the past 12 months.
Timepoint [21] 370851 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [22] 370852 0
Sexual behaviour (subsidiary outcome)
Assessed using items taken from the 5th National Survey of Australian Secondary Students and Sexual Health (2013), and assess age of kissing, sexual activity and condom use.
Timepoint [22] 370852 0
Measured at 24-months and 48 months post baseline (from when students are in Year 10, aged 15-16 years).
Secondary outcome [23] 370853 0
Trauma (subsidiary outcome)
Assessed using the Trauma Behavioural Risk Factor Surveillance System – Adverse Childhood Experience Module (BRFSS-ACE; Centers for Disease Control and Prevention, 2009, 2010).
Timepoint [23] 370853 0
Measured at baseline and 48 months (abuse items only included at 48 month timepoint).
Secondary outcome [24] 370955 0
Bullying (subsidiary outcome)
Assessed using three items from the Sources of Strength trial (Calear et al., 2016), which assess bullying, cyber-bullying and bullying others.
Timepoint [24] 370955 0
Measured at baseline, post-intervention, 12-, 24-, 36, 48 and 60 months post baseline.
Secondary outcome [25] 370956 0
Cognitive functioning (subsidiary outcome)
Assessed using a combination of several executive function tasks to provide an index of emotional control and cognitive functioning using the Wisconsin Card Sorting Task (Berg, 1948), the Backward Span Task (Wechsler, 1991), and a typing speed task.

Timepoint [25] 370956 0
Measured at baseline, weekly for the first six weeks, 6-, 12-,24-, 48- and 60 months post baseline.
Secondary outcome [26] 370957 0
Voice samples (subsidiary outcome)
Assessed using a speech task where participants are instructed to read words and phrases based on the Harvard Sentences (IEEE, 1969), designed to indicated whether voice changes can be used to reliably predict changes in mental health states.
Timepoint [26] 370957 0
Measured at baseline, week 2, week 4, post-intervention, 6-, 12-,24-, 48- and 60 months post baseline.
Secondary outcome [27] 371425 0
Activity and movement (subsidiary outcome)
A composite index assessed using the smartphone accelerometer and gyroscope sensors.
Timepoint [27] 371425 0
Measured continuously at a minimum sampling frequency of 1Hz (1 data point per second) for the first three months of the study.
Secondary outcome [28] 371426 0
Location (subsidiary outcome)
Assessed using the GPS smartphone sensor
Timepoint [28] 371426 0
Data is collected at a minimum of once every five minutes for the first three months of the study.

Eligibility
Key inclusion criteria
- Being in Year 8 at a participating school in NSW in 2019 or 2020
- Owning a smartphone
- Having active, parental opt in consent provided
- Providing active personal consent
Minimum age
12 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Allocation will be concealed. Schools will be randomly allocated to groups by the trial statistician, who is not involved in the day-to-day running of the trial for Stage I, and automatically by computer-generated randomisation for Stage II.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For Stage I, cluster randomisation (at the school level) will be employed for administrative convenience and to avoid control condition contamination. Schools will be randomised with a 1:1 allocation, as per a computer-generated randomisation schedule stratified by school size (<400 vs >400 students), school location (metropolitan vs non-metropolitan), school student gender (co-ed vs gender selective), and Index of Community Socio-Educational Advantage (ICSEA) level (<1000 vs >1000).

For Stage II, individual-level randomisation with a 1:1 allocation, as per as per a computer-generated randomisation schedule stratified by gender (male vs female) and depression severity scores (PHQ-A 10-15 vs =15).

Permuted block randomisation will be used at both stages but size will not be disclosed to ensure concealment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analysis of the primary outcome will be undertaken on an intention-to-treat analysis including all participants randomised regardless of intervention received. The primary analysis will be conducted using planned contrasts comparing a change in depression on the PHQ-A from baseline to 12-months between the trial arms (SPARX intervention vs. control), using a mixed-effects model repeated-measures analysis (MMRM). School will be included as a random effect to evaluate and accommodate clustering effects. Variables used in determining allocation balance will be evaluated and retained in analyses where they are significant or quasi-significant. An unconstrained variance–covariance matrix will model within-individual dependencies. Transformation of scores, including categorisation, may be undertaken to meet distributional assumptions and accommodate outliers.

Secondary and tertiary analyses will involve contrasts comparing change on secondary outcomes and tertiary outcomes from baseline to other occasions of measurement, using an MMRM approach, as described above. Contrasts comparing change on the PHQ-A at timepoints other than the primary endpoint (12 months) will be undertaken as secondary analyses. Number of participants meeting caseness criteria for depression based on the PHQ-A will be calculated and prevalence and estimated incidence rates will be compared across study arms at the 12-month assessment point and each subsequent annual assessment (24, 36, 48 and 60 months). Mediation analyses will be explored in structural equation modelling. Subsidiary complier analyses will be undertaken to compare individuals who complete the intervention relative to those who do not, in both trial Stages.

Cost-effective analyses will compare the cost of the SPARX intervention relative to the control condition via outcomes assessed using the Child Health Utility-9D (CHU-9D). Responses will be converted into health state values using the Australian adolescent scoring algorithm developed by Ratcliffe and colleagues (Ratcliffe et al., 2012) and will form the basis of the cost effectiveness analysis to estimate the incremental cost per QALY gained for the intervention relative to the control.

Recruitment
Recruitment status
Not yet recruiting
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
Recruitment postcode(s) [1] 26617 0
2000 - Sydney
Recruitment postcode(s) [2] 26618 0
2300 - Newcastle
Recruitment postcode(s) [3] 26619 0
2310 - Hunter Region
Recruitment postcode(s) [4] 26620 0
2250 - Gosford
Recruitment postcode(s) [5] 26621 0
2500 - Wollongong
Recruitment postcode(s) [6] 26622 0
2541 - Nowra
Recruitment postcode(s) [7] 26623 0
2340 - East Tamworth

Funding & Sponsors
Funding source category [1] 302879 0
Government body
Name [1] 302879 0
National Health and Medical Research Council
Address [1] 302879 0
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 302879 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
The University of New South Wales
Kensington, Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 302833 0
None
Name [1] 302833 0
Address [1] 302833 0
Country [1] 302833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303455 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 303455 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 303455 0
Australia
Date submitted for ethics approval [1] 303455 0
15/11/2018
Approval date [1] 303455 0
21/01/2019
Ethics approval number [1] 303455 0
HC180836

Summary
Brief summary
Research has shown that effective psychological prevention programs can prevent depression in approximately 22% of young people at risk. However, a major challenge is delivering these prevention interventions at scale, which have until now been expensive and typically delivered face-to-face. The Future Proofing study will identify how we can use smartphones to deliver effective psychological preventive interventions on a large scale, reaching young people universally by partnering with schools.

The aim of the study is to determine whether SPARX – an app-based Cognitive Behaviour Therapy (CBT) program can prevent the onset of depression in Year 8 school students, who will be followed up for five years. The study will also examine the effects of the intervention on a range of mental health symptoms, wellbeing, and drug and alcohol use at 12, 24, 36, 48 and 60 months. The study will also examine the effect of a second insomnia app (‘Sleep Ninja’) on depression in those who show high symptoms of depression 12-months after using SPARX.

The Future Proofing study aims to involve 20,000 Year 8 students from across 400 schools in New South Wales. It is anticipated that receiving a CBT prevention program at this developmental stage will significantly reduce the number of young people who go on to experience depression.
Trial website
www.futureproofing.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93714 0
Prof Helen Christensen
Address 93714 0
Black Dog Institute, University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 93714 0
Australia
Phone 93714 0
+61 2 9382 9288
Fax 93714 0
Email 93714 0
h.christensen@blackdog.org.au
Contact person for public queries
Name 93715 0
Dr Aliza Werner-Seidler
Address 93715 0
Black Dog Institute, University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 93715 0
Australia
Phone 93715 0
+61 2 9382 83803
Fax 93715 0
Email 93715 0
a.werner-seidler@blackdog.org.au
Contact person for scientific queries
Name 93716 0
Dr Aliza Werner-Seidler
Address 93716 0
Black Dog Institute, University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 93716 0
Australia
Phone 93716 0
+61 2 9382 83803
Fax 93716 0
Email 93716 0
a.werner-seidler@blackdog.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All individual level data will be deidentified and presented only in aggregate format.
What supporting documents are/will be available?
No other documents available
Summary results
No Results