This study is a randomised-controlled, single-blind trial with two intervention stages, each consisting of two-parallel arms (intervention and inactive control) with 1:1 allocation at each stage. Cluster-randomisation will occur at the school-level for the first intervention stage, stratified by school size, school location, school student gender and socio-economic status (full details below in the randomization section).
The second intervention stage will occur directly after the 12-month follow-up and involve individual-level randomisation. Stage I of the trial will have eight measurement occasions: Baseline (pre-intervention); Stage I post-intervention (immediately after completing the Stage I intervention, 6 weeks after baseline); and 6-, 12- (primary endpoint), 24-, 36-, 48- and 60-month follow-up. The follow-up period is time since baseline. For the subset of participants involved in Stage II of the trial, an additional measurement occasion will take place 6 weeks after the Stage II intervention (Stage II post-intervention). The trial will take place in three recruitment waves. It is planned that Wave 1 will commence in Term 3 2019 (July 2019), Wave 2 will commence in Term 2 2020 (April 2020), and Wave 3 will commence in Term 3 2020 (July 2020). The Stage I intervention phase (SPARX) will last 6 weeks and have a follow-up period of five years. The Stage II intervention phase (Sleep Ninja) will last six weeks, occurs 12 months after Stage I (SPARX), and have a follow-up period of up to four years.
Data from each assessment point will be used to determine safety and whether any modifications to the trial protocol are required (see analysis section for details). A concurrent implementation process evaluation will be conducted, and study processes may be modified to better address the needs of the school context. Any change will be reflected in the study protocol and registration (ACTRN12619000855123).
This trial will be conducted in approximately 400 schools located predominantly in New South Wales, Australia. The school system in Australia is divided across into main school types: government schools, independent schools and Catholic schools. Schools from each of these groups will be recruited into the study. Schools across metropolitan, regional and rural locations will be invited to participate in order to generate a demographically representative sample. Similarly, schools with differing indices of community socio-educational advantage (ICSEA) will be targeted. If recruitment targets are not met, schools in Australian states outside of New South Wales will be invited to participate. Recruitment is broadly aligned to the academic calendar, with delivery occurring during Term 2 (April) and Term 3 (July) such that assessment sessions take place during the school calendar year and risk issues can be addressed without delay. The first trial recruitment wave will be conducted primarily in independent schools in metropolitan Sydney and the Central Coast for reasons of convenience. The second and third waves will include both metropolitan and non-metropolitan sites, and include government, Catholic and independent schools. Trial management will take place at the Black Dog Institute, a translational research institute located in Sydney, Australia that is affiliated with the University of New South Wales (UNSW).
As this is a universal prevention study, there are no exclusion criteria. All adolescents enrolled in Year 8 at each participating school are eligible to participate in the trial if they have a smartphone with iOS or Android operating system and an active mobile phone number. The usual age range of students in Year 8 is 12–14 years, although Year 8 students outside of this age range will not be excluded.
Youth and Public Involvement
Young people, parents and consumers have been consulted in the preparation phase for the current study. Recruitment processes and study materials were reviewed by the Lived Experience Advisory Panel at the Black Dog Institute, and a local school’s Parents & Citizens (P&C) Association, with changes made based on suggestions provided. Young people both through the Black Dog Institute network, and a local mental health service youth reference group have been involved in reviewing all the questionnaires and informed the wording of questionnaires and explanation of concepts using ‘explainers’ to aid clarity. The two interventions have been subject to youth feedback in previous trials and iterations of the programs. For example, young people who have previously used the SPARX intervention provided acceptability feedback in a previous trial (23) while Sleep Ninja was developed in collaboration with young people, and a sample of 50 young people provided feedback about the intervention in acceptability surveys and interviews (32).
A flowchart outlining recruitment into the trial, randomisation at trial Stages I and II, the study timeline and participation is outlined in Figure 1. Approximately 400 schools will be recruited to participate in the trial via several recruitment pathways. The characteristics of the sample will be compared to school census data to determine representativeness. Schools will be recruited in three waves over two years: one wave for commencement of the trial in Term 3, 2019 (14 schools), then another two waves in Terms 2 and 3, 2020 respectively (approximately 386 schools).
School principals will be contacted in the first instance. They will be given brief information sheets containing trial details. Schools will have the opportunity to hear more information over the phone or via video conference. Those who wish to take part will be instructed to sign and return a letter of support. Upon receipt of the letter, schools will be accepted into the trial. In some instances, schools may approach the Black Dog Institute by submitting an expression of interest via a link on the study website (http://www.futureproofing.org.au), or by directly contacting staff at the Black Dog Institute.
After schools have consented, parents and students will be informed about the trial by their school via email or newsletter, depending on school preferences. A study invitation will be circulated to parents. This will include a link to an electronic information sheet and consent form. Here, parents and students can read information about the study, download a PDF copy of the study information sheet and provide electronic consent. Fourteen days following consent form distribution, schools with capacity will make follow-up phone calls to parents who have not submitted a response. The option to provide verbal consent will be given to these parents. Students whose parents have consented to their participation will be given the opportunity will provide consent electronically at the start of the first study session. Students who do not provide active consent cannot participate in the trial. All recruitment strategies have ethical approval.
The Black Dog Institute has existing relationships with 100 schools in New South Wales, both through previous research studies and via delivery of community mental health literacy programs to high school students. These relationships will be leveraged to support school recruitment. To maximise school consent rates, potential schools will be approached at least one school term in advance of study implementation. This means that schools can schedule study activities well in advance. Schools who participate in Wave 1 of the study will also be eligible to participate in Waves 2 or 3 (as these occur in the subsequent year and therefore involve a different cohort). As a universal study, schools will be encouraged to organise data collection assessment sessions as whole-of-classroom activities. To maximise parental consent rates, an information video specifically designed for parents will be made available, and parents have the option to directly contact the research team for further study information.
This trial will involve two interventions: a universal prevention intervention (Stage I; SPARX) and an indicated prevention intervention (Stage II; Sleep Ninja) for participants showing elevated depressive symptoms 12-months after receiving the universal intervention. Participants can begin or continue with any existing treatments during the study, including antidepressants and psychotherapy, and may receive additional support from health professionals if required.
SPARX is a gaming intervention that was developed as a treatment program for mild-moderate depression (29). In its original form as a computerised game, research has shown SPARX to be effective in the treatment of adolescent depression, and equally effective as treatment as usual, which primarily involved face-to-face psychotherapy with a mental health professional (29). This trial will use SPARX-Future Proofing (SPARX-FP; referred to as SPARX in all other sections of the document), which is an adaptation of SPARX, to make it suitable for the prevention of depression, for delivery via mobile phone application. The content is the same, but instead of a focus on existing symptoms and depression, terminology has been updated to focus on times when the participants have felt ‘down or stressed’ and included skills and strategies reframed to focus on dealing with problems as they arise. The prevention version of SPARX has been trialled in an Australian sample of 540 final year secondary school students. This trial showed that, relative to a control group, those who used the program showed lower symptoms of depression in the lead up to final school exams (23). The move to a mobile phone application from a web-based program was informed by this previous study finding technological barriers and participant preferences for delivery via smartphone.
SPARX consists of seven modules (levels) which cover: finding hope, being active, dealing with strong emotions, problem solving, recognising unhelpful thoughts, challenging unhelpful thoughts and bringing it all together. Each module takes approximately 20 minutes to complete. Each module is designed to be completed on separate days, and users are encouraged to do one to two modules per week. Participants will have 6 weeks to complete the SPARX program on their personal smartphones, in their own time, or in class time if schools wish to offer it. Skills learnt through the SPARX program include emotion identification, emotion regulation, behavioural activation (being active), recognising and challenging unhelpful thoughts, and practical problem solving. This intervention is delivered in a game format, where participants begin by choosing a personalised avatar. The gaming component sees the participant undertaking skill-building challenges in the context of a fantasy world, where the aim is to restore balance in a world taken over by gloomy, negative, automatic thoughts. The gaming component is supplemented by direct instruction, education and activities (or homework) provided by a ‘guide’ avatar, who relates the content of the program to users’ real life experiences.
Sleep Ninja is a smartphone app based on CBT-I, which is the gold standard, evidence-based treatment for insomnia. Sleep Ninja was developed in collaboration with young people, and has been tested for feasibility, acceptability and preliminary effects on insomnia and depression (32, 39). The intervention involves 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 character (who acts as a sleep coach). 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 by the end of the program. To level up to the next belt, users must complete within a one-week period: (i) one training session (which takes approximately 5–10 minutes) and; (ii) three nights of sleep tracking using a sleep diary within the app. At the completion of each level, users are provided with a brief report card and graph summarising their self-reported sleep over that period. There are additional optional app features that users can access which include a meditation recording, extra sleep information, quick sleep tips and an easy way to send app-information to parents. 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, and a final reminder at bedtime for users to go to bed. Participants will have 6 weeks to complete the Sleep Ninja program in their own time on their personal smartphones.
Strategies to enhance and monitor adherence
To enhance adherence, digital notifications and reminders will be sent to participants reminding them to activate, visit and use the app/s as intended. School personnel will also provide verbal reminders and encouragement to students to use the Future Proofing App and for intervention arm schools, the first intervention app (Stage I; SPARX) during the intervention implementation period. There will also be a $20 one-off incentive to cover any connectivity and data costs delivered at post-intervention to participants in both arms (6 weeks), which may serve to improve adherence. Adherence to the intervention app/s will be monitored by evaluating usage data that is collected automatically by the apps while they are active. Usage data is available at the individual level and consists of when and how many times users enter the apps, how long they spend in the app, how many modules they complete, and for Sleep Ninja only, any sleep tracking data that is inputted by the user.
The administration schedule for each of the assessment measures described below is provided in Table 1.
Primary outcome measure
Patient Health Questionnaire—Adolescent Version
The primary outcome measure is depression severity measured at 12-months post-baseline using the Patient Health Questionnaire for Adolescents (PHQ-A; 38). PHQ-A depression scores will also be collected at baseline, 6-weeks post-intervention (Stages I and II), and at 6, 24, 36, 48, and 60-months post-baseline. The PHQ-A is a validated modification of the PHQ–9 for adolescents, a 9-item self-administered depression severity screening and diagnostic tool based on DSM-IV criteria. The scale assesses the frequency of occurrence of nine depression symptom criteria during the previous two weeks, with items rated on a 4-point scale ranging from 0 (Not at all) to 3 (Nearly every day). Total scale scores on the PHQ-A depression scale can range from 0–27, with higher scores reflecting more severe depressive symptoms. The accepted clinical cut-offs are as follows: a score of 0–4 indicates nil to minimal symptoms, 5–9 indicates mild symptoms, 10–14 indicates moderate symptoms, 15–19 indicates moderately severe symptoms and 20–27 indicates severe symptoms. The psychometric quality of the PHQ–9 and PHQ-A is well established (38, 40).
Secondary outcome measures
Secondary outcomes will be monitored for the duration of the trial at baseline, 6-week post-intervention (Stages I and II) and the 12-, 24-, 36-, 48- and 60-month follow up assessments (see Table 1 for the specific measurement occasions corresponding to each outcome measure). The presence of mental health symptoms will be determined by established cut-offs relevant to each scale. Analyses will be comparisons of mean scores between the intervention and control arms at each time point. The following measures will be used to assess the secondary outcomes:
The Distress Questionnaire–5 (DQ–5; 41) is a 5-item brief screening tool for identifying general psychological distress. Respondents rate each item on a 5-point scale, ranging from 1 (Never) to 5 (Always). The total scores on the scale range from 5 to 25, with higher scores indicating greater psychological distress. The scale has demonstrated optimal to high internal consistency and convergent validity, and has been found to be more accurate in identifying psychological distress than some other commonly used screeners (41, 42).
Spence Children’s Anxiety Scale Short-Form (including Generalized Anxiety and Social Phobia Subscales)
The Spence Children’s Anxiety Scale Short-Form (SCAS-SF) is an 8-item brief measure of anxiety for children and adolescents, based on the SCAS (43). The SCAS was designed to measure the severity of children and adolescents’ anxiety symptoms based broadly on DSM-IV criteria for anxiety disorders (44). Respondents rate the degree to which they experience each symptom on a 4-point frequency scale, ranging from 0 (Never) to 3 (Always). Total scale scores on the 8-item SCAS-SF can range from 0–24, with higher scores reflecting greater anxiety. The SCAS Social Phobia (6 items; total scores = 0–18) and Generalised Anxiety (6 items; total scores = 0–18) subscales will also be administered in this trial to provide specific validated measures of these common anxiety disorders in adolescents. The SCAS has demonstrated high internal consistency and satisfactory test-retest reliability (43). The SCAS has also been reported to show both convergent and divergent validity (45).
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a psychometrically sound, 7-item self-report measure of insomnia symptoms over the previous two weeks (46). Responses are reported on a Likert scale ranging from 0 (Not at all) to 4 (Very), producing total scores of 0 to 28. Cut-off scores are as follows: 0–7 reflects no clinically significant insomnia, 8–14 indicates subthreshold insomnia, 15–21 suggests moderate severity insomnia, and 22–28 indicates severe insomnia. The ISI was designed for use in adults but has been widely administered to, and validated in, adolescent samples (47, 48).
Additional outcome measures, potential mediators and risk factors
The following additional outcome measures will be examined and reported separately from the primary and secondary outcomes. Also included are variables which may mediate outcomes in the intervention arms. Potential risk factors for the development and maintenance of mental health disorders are also included (see Table 1 for the specific measurement occasions corresponding to each measure).
Suicidal Ideation Attributes Scale
The Suicidal Ideation Attributes Scale (SIDAS) is a recently developed brief measure of suicidal ideation severity in the past month. Using a general population sample, it has demonstrated high internal consistency and good convergent validity (49). The SIDAS consists of five questions pertaining to frequency of thoughts, controllability of thoughts, closeness to attempt, level of distress associated with the thoughts, and impact on daily functioning. Each item is assessed on a 10-point scale. Endorsement of item 3 (how close the individual has come to making an attempt in the last month) will trigger the trial’s risk management procedure (see details below). A total scale score is calculated by summing item scores and can range from 0 to 50. Higher scores indicate higher levels of suicidal ideation severity.
Youth Risk Behaviour Survey
The Youth Risk Behaviour Survey (YRBS) was designed to assess health risk behaviours among secondary school students. Three items from the YRBS will be used in the current trial to assess suicide-related behaviours (thoughts, plans and attempts) in the past 12 months, for which participants indicate a ‘Yes’ or ‘No’ response. Studies have shown that the suicidality items demonstrate both substantial reliability (50) and good convergent and divergent validity in a secondary school sample (51).
Strengths and Difficulties Questionnaire
The Strengths and Difficulties Questionnaire (SDQ; 52) is a widely used behavioural screening questionnaire for 4 to 17 year-old children and adolescents. It consists of 25 items divided between 5 sub-scales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems and Prosocial Behaviour. Respondents indicate on a 3-point Likert scale the extent to which each item applies to them, using the options 0 (Not true), 1 (Somewhat true), or 2 (Certainly true). Total scale scores on each of the sub-scales can range from 0–10. A higher score is indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behaviour. The SDQ has demonstrated good internal consistency across studies (53, 54).
Screen for Disordered Eating
The Screen for Disordered Eating (SDE; 55) was recently developed to screen for eating disorders. The SDE comprises five items, to which respondents indicate whether they experience any disordered eating on a dichotomous scale (Yes or No). An individual is screened as positive if he/she endorses two or more items. In the primary care setting, this measure has demonstrated good discriminative accuracy (55).
The Self-Harm Questionnaire (SHQ; 56) was designed to improve identification of self-harm in adolescents. The complete questionnaire consists of three screening questions enquiring about any past incidents of self-harming behaviour or thinking, followed by 12 additional questions that are only presented to adolescents reporting previous self-harm. Among a sample of psychiatric service in- and outpatients, the SHQ has demonstrated good concurrent and predictive validity (56). To assess self-harm prevalence and frequency in the current trial, only screening item 3 will be administered in order to assess past episodes of self-harm (‘Have you ever actually harmed yourself on purpose? For example, have you ever cut yourself or taken an overdose and it was not an accident?’). Participants respond to this item on a 4-point scale of ‘No’, ‘Yes, once’, ‘Yes, two, three or four times’ and ‘Yes, five or more times’. This item will allow the assessment of the prevalence of self-harm and its frequency.
Alcohol Use and Substance Use Questionnaires
The Alcohol Use questionnaire included in this trial was originally adapted from the School Health and Alcohol Harm Reduction Project (57) and used the Climate Schools Projects (58), which are Australian school-based trials aimed at reducing alcohol and cannabis use. The questionnaire includes a standard drink diagram contains nine items assessing age of first use, alongside frequency and quantity of alcohol use. An additional questionnaire assessing Other Substance Use was adapted from the Australian Institute of Health and Welfare 2007 National Drug Strategy Household Survey. The questionnaire 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), and also assesses tobacco, amphetamine, ecstasy, hallucinogens, sedatives and inhalant use.
Adolescent Psychotic-Like Symptom Screener
The Adolescent Psychotic-Like Symptom Screener (APSS; 59) is a 7-item measure designed to identify people who are at increased risk of future clinical psychotic disorder. In this study, only three items will be administered to assess paranoia, auditory and visual hallucinations. For each question, there are 3 possible responses: ‘Yes, definitely’, ‘Maybe’, ‘No, never’. Responses are scored 1, 0.5, and 0 respectively. Higher total scale scores on this measure are indicative of greater psychotic-like symptoms. In the general population, this instrument has demonstrated good sensitivity and specificity in identifying young adolescents with psychotic-like experiences (59).
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI; 60) was designed to assesses sleep quality and disturbances over a 1-month interval. It consists of 19 items, which are used to compute seven component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications and daytime dysfunction. Each item is weighted equally on a scale that ranges from 0 (no difficulty) to 3 (severe difficulty) scale. The seven component scores are then summed to yield a global score, ranging from 0 to 21; higher scores indicate worse sleep quality. The PSQI has demonstrated acceptable to good internal homogeneity, test-retest reliability and convergent validity across studies (60–62).
Child Health Utility 9D
The Child Health Utility 9D (CHU–9D; 63) is a 9 dimension generic preference-based measure designed to assess child and adolescent health related quality of life and suitable for application in economic evaluation. Current child/adolescent health related quality of life is assessed across the domains of worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine and activities. Each dimension is rated on a 5-point response scale ranging from ‘no’ to ‘severe impairment’. Responses are then converted to utilities on the 0–1 dead to full health quality adjusted life years scale (QALY) using a preference weighted scoring algorithm (64). Previous validation studies with adolescents from the community and mental health services have demonstrated that the self-complete instrument has acceptable internal consistency and convergent validity for children and adolescents age 7 to 17 years (65–67).
Short Warwick-Edinburgh Mental Wellbeing Scale
The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS; 68) is a shortened 7-item version of the 14-item Warwick–Edinburgh Mental Well-being Scale (WEMWBS), which was developed to assess mental wellbeing in the general population. The SWEMWBS consists of seven statements about thoughts and feelings over the past two weeks. Ratings are made on a 5-point Likert scale (1 = None of the time, 2 = Rarely, 3 = Some of the time, 4 = Often, 5 = All of the time). Total scale scores are calculated by summing item scores and transforming the total score using a conversion table. Total scores can range from 7 to 35. A higher score indicates a higher level of mental well-being. The SWEMWBS has demonstrated adequate reliability and validity across studies (69, 70).
At the baseline assessment, participants will be asked to provide their date of birth, postcode, country of birth, language spoken at home, who they live with at home, Aboriginal and Torres Strait Islander status, and socioeconomic status (71).
Height and Weight
Self-reported height (cm) and weight (kg) will be provided.
Big Five Personality Inventory
The Big Five Personality Inventory (BFI–10; 72) is a 10-item scale measuring the Big Five personality traits: Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness. The scale was developed based on the 44-item Big Five Inventory (BFI–44; 73). Respondents indicate their level of agreement with each described trait on a 5-point scale, ranging from 1 = ‘Disagree strongly’ to 5 = ‘Agree strongly’. Total sub-scale scores are calculated by summing item scores (two items per sub-scale). Subscale scores can range from 2 to 10. The BFI–10 has demonstrated acceptable test-retest reliability and good construct validity across studies (72, 74).
School connectedness will be assessed using questionnaire items developed by the Organisation for Economic Co-operation and Development (OECD) Programme for International Student Assessment (75). Six items will be administered, which are rated on a four-point scale from 1 (Strongly agree) through to 4 (Strongly disagree). Total scale scores can range from 6 to 24, with higher scores reflecting greater school connectedness.
Schuster Social Support Scale
The Schuster Social Support Scale (SSSS; 76) is a 15-item measure of positive and negative interactions with family, friends and spouse. In the current study, 10 items will be administered to assess interactions with family and friends only. Each item is rated on a 4-point scale ranging from 0 (Never) through to 3 (Often). Scores are interpreted per category, for friends and family, with higher scores on the supportive interactions scales indicative of more supportive interactions, and higher scores on the negative interactions scales indicate more negative interactions.
Maladaptive Facebook Usage Scale (Adapted)
The Maladaptive Facebook Usage Scale (77) is a 7-item measure of maladaptive Facebook usage, which assesses an individual’s tendency to undertake negative social evaluations and social comparisons when they use Facebook. This scale has demonstrated good test-retest reliability and convergent validity (77). In this trial, the scale has been adapted to incorporate social media more broadly. A screening item has been added asking respondents to nominate which social media platforms they use at least once per week. Options include: Facebook, Instagram, Snapchat, Tumblr, Twitter, YouTube, Reddit, Other, and “I don’t use social media”. The seven items of the Maladaptive Facebook Usage Scale were adapted to apply to any social media platform, e.g. ‘I tend to read the social media status updates of others to see if they are feeling the way I am,’ and ‘Reading the social media status updates of others tends to make me feel down on myself’. Items are rated on a 1 (Strongly Disagree) to 7 (Strongly Agree) response scale. Total scale scores can range from 7 to 49. Higher scores indicate greater tendencies to seek online social comparisons and negative evaluations.
Gender Identification and Sexual Identification/Preferences
Gender identification (two items: sex at birth and current gender identity), and sexual identification and preferences (one item for each) will be examined at baseline and annually between 12- and 60-month follow up.
Two items will be presented at multiple time-points to assess romantic relationships. These items will ascertain 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.
A series of questions will be presented at the 24-month follow-up when participants are in Year 10 (aged 15–16 years) to assess sexual behaviour, taken from the National Survey of Australian Secondary Students and Sexual Health (78). These items will assess experience and age of first “making out”, intimate genital touching and sex, as well as number of people they have had sex with during the past year and frequency of condom use. This section will include an initial gating item assessing history of intimate sexual contact. Those who do not endorse this item will not receive the other sexual behaviour items.
Trauma Behavioural Risk Factor Surveillance System—Adverse Childhood Experience Module
The Trauma Behavioural Risk Factor Surveillance System—Adverse Childhood Experience Module (BRFSS-ACE; 79) consists of 11 items that assess exposure to nine types of adverse childhood experiences in the first 18 years of life, including: verbal abuse, physical abuse, sexual abuse, household mental illness, household alcohol abuse, household drug abuse, domestic violence, parental separation/divorce, and incarcerated family members. The responses are dichotomised to indicate exposure and summed to create an ACE score ranging from 1 to 8 for each subdomain, with higher scores indicating greater exposure. Previous studies have demonstrated that this instrument has adequate internal consistency and validity (80, 81). In this trial, the complete BRFSS-ACE will be administered at 48-month follow up when participants are near 18 years of age. A modified version of the questionnaire consisting of 8 items will be administered at baseline when participants are approximately 13 years old. This modified scale excludes items on physical and sexual abuse, and includes additional items assessing out of home or foster care and feelings of endangerment or physical harm.
History of Mental Health Diagnosis
One item will assess lifetime history of diagnosed mental health problems (Major Depression, Social Anxiety Disorder, Generalised Anxiety Disorder, Obsessive Compulsive Disorder, Panic Disorder, Alcohol Use Disorder, Substance Use Disorder, Attention Deficit Hyperactivity Disorder, Post Traumatic Stress Disorder, Schizophrenia/Psychosis).
One item will assess hospitalisation in the previous 12 months and will ask participants to distinguish between hospitalisation for physical and mental health problems.
History of Disability Diagnosis
One item will assess lifetime history of diagnosed disability (Autism or Asperger’s Syndrome, Intellectual Disability, Specific Learning Disability, Tourette Syndrome, Cerebral Palsy, Acquired Brain Injury, Other Neurological Disability, Hearing Impairment, Visual Impairment).
Open ended questions for females and males will be used to assess pubertal development (e.g. ‘at what age did you get your first period/did your voice begin to break?’). Participants will also be provided with line drawings of stages of pubertal development (Tanner Stages) and asked to rate their current stage of physical development against these images.
Bullying items were drawn from previous school-based trials. The three items examine whether participants have been bullied, cyber bullied, or bullied others in the past 12 months. Items are responded to on a 5-point frequency scale from 1 (Not at all) to 5 (Most days).
App Use and Feedback Surveys
App use and feedback surveys for both the Future Proofing App and SPARX app will be administered at the post-assessment time point. The Future Proofing App Survey was developed for this study and has 9 items which assesses app task preferences and reasons for discontinued use. The SPARX Feedback Survey is an 11-item survey that has been used previously to assess SPARX use (23), app acceptability and asks participants to select any skills they learnt from using the app.
Smartphone collected data
Additional data will be collected directly via smartphones through a study app developed for this study (the Future Proofing App), as this data cannot be collected from the self-report questionnaires outlined above. Three forms of data will be collected, which include actively collected data, passively collected data, and app usage data. Actively collected data will assess self-reported mood ratings, voice samples and cognitive tasks. This form of data will overcome biases in retrospective reporting of mood and allow for an investigation of whether changes in voice are related to changes in mental health states. Cognitive tasks include two measures of executive function presented in affective and neutral contexts. Specifically, a measure of affective shifting (82) and the Affective Digit Span (83) and a typing speed task, which will allow for a mechanistic assessment of the way cognitive function affects psychological outcomes in adolescents.
Passively collected smartphone data will involve the collection of location data (GPS) and movement data (accelerometry), which will be used to investigate whether mental health changes can be predicted from location and activity data. Smartphone sensor data will be collected during the first three months of the study, and at each annual assessment point for three month periods. App usage data will allow for assessment of app use and completion, and time spent using the study app/s.
Data relating to participants’ academic outcomes, physical health, utilisation of health services, infant development, births and deaths will be linked from extant Australian government administrative datasets by an authorised agency of the New South Wales Ministry of Health, the Centre for Health Record Linkage (CheReL, www.cherel.org.au). Informed consent from each participant will be obtained prior to linkage and databases will be linked using personal identifiers such as names, dates of births, addresses and hospital identification numbers with probabilistic methods. Linked data will be provided to the researchers in a de-identified manner and will be used to determine related health and other outcomes for the participant, including birth and perinatal data, educational outcomes in standardized curriculum-based tests and hospitalization and mortality outcomes. Linkage will occur within the first 12 to 24 months of the study (at the end of 2020) and will be updated periodically every two years until the trial concludes.
Procedure and participant timeline
Figure 1 shows participant timeline and flow. An initial preparatory phase and first school visit will solicit parental and student consent, ensure that electronic study questionnaires are accessible by consented students and that the appropriate study apps are installed on each student’s device. Each subsequent school visit will coincide with an assessment occasion. During these visits, students will access study questionnaires via a secure online portal, accessible using their mobile number and a one-time password sent via SMS. Study personnel will attend these school visits to assist with technical issues and participants’ questions. Following completion of baseline questionnaires, participants in the intervention condition will be instructed to commence the intervention and will receive notifications and reminders over the following six weeks to complete the intervention in their own time. After each assessment occasion, schools will be encouraged to hold ‘catch up’ sessions for students who do not complete their assessments (e.g., who are absent from school that day). Students who do not complete assessments in school will also have the option to do this in their own time. Students will have two weeks following the scheduled assessment date to complete questionnaires at each time point, after which the assessment surveys will be locked and no longer accessible. During this two-week window, automated electronic reminders will be sent to students to prompt completion, if required.
Separate sample size estimates were derived to determine the numbers of participants needed to meet the aims of each trial stage. Power was set at 0.80, α =.05 (two tailed), and a correlation of 0.5 assumed between baseline and endpoint symptom scores. To account for possible clustering effects at Stage I (i.e., participants from the same school having prognostically relevant characteristics and outcomes more alike than between schools), a design effect (84) was calculated assuming an intraclass correlation coefficient (ICC) of.03 (based on previous school-based studies; 85), and a cluster size of 50 students, yielding a design effect of 2.47. In order to detect a mean standardized difference of 0.3 between conditions at Stage I, a sample of 870 participants would be needed (435 per arm). Allowing for up to 30% attrition, recruitment of 1244 participants would be required (622 per arm).
Using similar parameters for Stage II (without a design effect) would require recruitment of just over 500 participants in total. However, participants in this stage must meet eligibility requirements regarding elevated symptoms and failure to respond to the first stage intervention. They must also be willing to participate. Accordingly, a scenario involving recruitment of 20,000 participants at Stage I was considered. Allowing for loss to follow-up of 30%, 7,000 participants would have endpoint data available at 12 months. Conservatively estimating 20% having PHQ-A scores >10, 25% showing a reduction due to the Stage I intervention, and that 60% of those eligible to enrol at Stage II do so 630 participants would enter this stage II, with endpoint data available for at least 440 (allowing for up to 30% attrition). This sample would enable the detection of differences in changes in symptomatology scores of comparable size to those in Stage I of the trial (0.28 standard deviations).
Given that a target sample of 20,000 is substantial, if the numbers of participants are not sufficient to reach the Stage II target, supplementing this sample with additional young people specifically targeted based on PHQ-A scores that fall in the top 20% of population scores to ensure that this stage of the trial has comparable power as Stage I to detect an intervention effect will be considered. This will ensure that sufficient numbers are be included at both stages of the trial. Should the target be met, Stage I of the trial will have much higher power to detect changes in symptom scores and would be adequately powered to detect differences in incidence of based on PHQ-A diagnosis criteria.
Exploratory analyses for moderating and mediating effects will be feasible at both Stages. Stage II will have power to detect small to medium mediation effects (86). Power to detect medium size effects (0.5 SD) in moderation analyses will be maintained for subgroups down to approximately 120 participants. Power will be enhanced in longitudinal modelling (growth curves) which use multiple occasions of measurement to estimate rates of change (86).
For Stage I, cluster randomisation (at the school level) will be employed for administrative convenience, to avoid control condition contamination, and for the ecological validity of providing the intervention at the cluster level. Schools will be randomised after they are recruited into the trial. The trial statistician who is not involved in the day-to-day running of the trial will perform the randomisation, and the identity of the school will be concealed from the statistician.
Schools will be randomised with a 1:1 allocation, as per a computer-generated randomisation schedule. Balance between the trial arms will be achieved by stratifying based on school size, school location (metropolitan vs regional), school type (co-ed or gender-selective) and Index of Community Socio-Educational Advantage (ICSEA) level. For Stage II, individual-level randomisation with a 1:1 allocation using a computer-generated randomisation schedule stratified by gender and depression severity scores will be employed. This procedure is automated through the Black Dog Institute research platform. Permuted block randomisation will be used at both stages but will not be disclosed to ensure concealment. Allocation to arm is not directly communicated to schools. However, because the study has no control intervention, schools, participants and study operational staff will be aware of school allocation to the intervention arm. With the exception of the trial data manager, other individuals not involved in the day to day running of the trial will remain blind to allocation. All outcome assessments are conducted electronically and not subject to assessor bias. Unblinding at the conclusion of analysis will be performed by the trial data manager with authorisation from the trial management committee.
Participant risk management protocol
An independent Data and Safety Monitoring Committee (DSMC) has been established to monitor the quality of trial data and the safety of research participants. The DSMC will be responsible for safeguarding the interests of participants through regular monitoring, including participant safety and adverse events. This group will be responsible for monitoring the efficacy of the interventions being tested on primary and secondary outcomes, as well as the overall conduct of the study, including recruitment, protocol compliance, accuracy and completeness of data collection. This group will also provide recommendations with respect to continuing, modifying or terminating the trial, on the basis of feasibility or safety concerns.
All students involved in the trial will be assessed for suicidal thinking and behaviour at each assessment point, using the SIDAS and YRBS. If participants indicate serious suicidal thinking, plans or behaviour on study surveys, an alert will be triggered whereby the research team and school counsellor are notified immediately using a purpose-built study portal. School counsellors will then follow-up with students within 48 hours to offer immediate support, or refer on when necessary, which is recorded in the portal. The research team will monitor this portal and directly contact any counsellors who have not indicated follow-up with students. If students have changed or left schools, parents will be notified. At the 48-month assessment point when students are in their final year of school, they will also be asked about a history of sexual abuse. If students indicate an experience of sexual abuse, this same process of notifying the school counsellor will be followed, and schools will assume the duty of care for mandatory reporting requirements. This information will be communicated to relevant university and school ethics committees, as well as the DSMC following each assessment point.
Data collection and management
All research data collected in this trial will be stored using a unique participant Id code. A list of identifiable participant information associated with each Id code will be stored separately to the research data. The privacy, security and ownership of the research data will be maintained and re-identifiable data will not be stored or accessible by another organisation. Access, storage and transmission logs will be recorded and regularly reviewed for anomalies.
The data that will be collected includes questionnaire data, mobile phone data, and linked data. Coded questionnaire outcome data will be stored securely on the Black Dog Institute online research platform until ready for export. The research platform is stored on UNSW servers and supported by enterprise access controls and 256-bit encryption or higher. Data will be exported from the research platform into Microsoft Excel following assessments so that it can be checked by the data manager for data quality and accuracy. After checking, data will be exported into appropriate statistical software for analysis. Data collected by mobile phone apps will be encrypted and transmitted to a secure database hosted by Google Cloud Services in Australia. Data will be securely removed and transferred on a scheduled basis to UNSW servers by the trial data manager. Access to Google Cloud Services and the UNSW server will require authentication and will be restricted to the data manager and named members of the research team. The data manager will be responsible for extracting and securely transferring data to the research team. Only researchers whose analyses require access to the specific dataset collected from each questionnaire, app and linkage data source will be able to access those data. Linked datasets will be subject to the requirements set out by linking agencies for storage on UNSW servers using the above outlined procedures.
Analysis of the primary outcome will be undertaken using an intention-to-treat approach including all participants randomised regardless of intervention received, controlling for baseline differences when appropriate. The primary analysis will be conducted using planned contrasts comparing a change in depression scores on the PHQ-A from baseline to 12-months between the trial arms (SPARX intervention vs. control), using a mixed-effects model repeated measure analysis (MMRM). MMRM is preferred due to the ability of this approach to include participants with missing data without using discredited techniques such as last observation carried forward (87, 88). 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 additional outcomes
Secondary and additional outcome analyses will involve contrasts comparing change on secondary (DQ–5, SCAS, ISI), and other (e.g., SIDAS) outcomes from baseline to other occasions of measurement, using an MMRM approach, as described above.
Subsidiary complier analyses will be undertaken to compare individuals who complete the intervention relative to those who do not, in both trial stages. Regression models will be used to examine risk factors for symptoms of psychopathology across the study measurement points in the control arm. Mediation analyses will be explored using structural equation modelling. Machine learning approaches will be used to link multiple data types with outcomes to discover novel factors which predict outcomes in terms of specific disorders and their progression as well as investigate individual patterns of data that predict individual mental state or symptom trajectory. Cost-effectiveness analyses will be conducted at the primary endpoint and the final measurement point. Data will be linked to existing records and education and health outcomes will be reported.
The percentage of participants meeting PHQ-A depression caseness, scores and reporting of suicidality at each assessment within both groups will be measured and reviewed by the DSMC in order to monitor relative levels of deterioration (accounting for baseline levels), for safety purposes.
Ethics and dissemination
This study has ethical approval from the University of New South Wales Human Research Ethics Committee (HC180836) and NSW Government State Education Research Applications Process Approval (SERAP 2019201) and has applied for approval from Catholic dioceses. The trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTRN12619000855123). All protocol amendments will be subject to approval by relevant ethics committees and listed on the ANZCTR registry. All trial findings will be presented in aggregate format so that no individual level data will be presented.
Trial findings will be communicated using lay language and will be made available to participating schools for publication in school newsletters and/or school websites. Participants and parents will also be provided with these findings via email. Regular trial progress updates will be provided by the research team to schools for distribution through the school community, at their discretion. These findings will also be provided to other stakeholders in the wider community, including to government in policy documents, to school counsellor bodies, teacher groups and mental health groups. All findings will be provided in aggregate level. The results of the trial will be disseminated via peer-reviewed publications in scientific journals and conferences. No restrictions have been imposed on the dissemination of information by funders.