Background: Process evaluations provide insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the detailed protocol for a process evaluation embedded in a cluster randomised trial of a digital depression prevention intervention delivered to secondary school students (The Future Proofing Study). The purpose of this manuscript is to describe the methods that will be used to capture process evaluation data within this trial. Methods: A mixed methods design will be used for this process evaluation with data collected in the intervention arm of the Future Proofing Study. Data collection methods will include semi-structured interviews with school staff members and study facilitators, automatically collected intervention usage and completion data, and participant questionnaires (completed by school staff, school counsellors, study facilitators, and school students). Information will be collected about: i) how the intervention was implemented in schools, including fidelity; ii) school contextual factors and their association with intervention reach (including completion), uptake and acceptability; iii) how school staff, study facilitators, and students and responded to delivering or completing the intervention. How these factors relate to trial effectiveness outcomes will also be assessed. Overall synthesis of the data will provide school cluster-level and individual-level process outcomes. Discussion: This process evaluation provides a detailed description of how to embed a process evaluation into a trial of a complex intervention in schools. It will provide important information about the Future Proofing Study from the perspectives of key groups necessary for implementation – school-teachers, school counsellors and other school staff, as well as study facilitators and students. An understanding of school contextual factors that hinder or facilitate intervention reach and uptake will be provided. Results will also contextualise the trial findings with respect to how the intervention may have worked in some schools but not in others. Furthermore, this process evaluation will inform the development of a model for rolling out digital interventions for the prevention of mental illness across the school sector. Trial Registration: The randomised controlled trial has been prospectively registered: ACTRN12619000855123. Registered 31 May 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377664&isReview=trueContributions to the Literature· Process evaluations are critical for understanding how interventions are delivered in real world contexts but are rarely embedded in randomised controlled trials or detailed in prospective protocols. · This protocol is the first to illustrate how to embed a process evaluation into a school-based trial of a digital depression prevention intervention, including the use of flexible and pragmatic quantitative and qualitative data collection methods with key stakeholders. · School context factors will be rigorously assessed and analysed for contribution to intervention reach and completion, uptake of study processes, and clinical outcomes. · Study outcomes will guide sustainability efforts in the delivery of digital depression prevention interventions in schools.

Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programs. However, barriers to implementing and accessing these programs remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programs. The Future Proofing Study is a large-scale school-based trial investigating whether Cognitive Behaviour Therapies (CBT) delivered by smartphone application can prevent depression.Methods A randomized controlled trial targeting up to 20,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomized at the cluster level to receive either the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level RCT (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur at post-intervention (both trial stages), and at 6, 12, 24, 36, 48- and 60-months post-baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed effect models.Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programs should be deployed in school-based settings in Australia and beyond.

Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programs. However, barriers to implementing and accessing these programs remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programs. The Future Proofing Study is a large-scale school-based trial investigating whether Cognitive Behaviour Therapies (CBT) delivered by smartphone application can prevent depression.Methods A randomized controlled trial targeting up to 20,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomized at the cluster level to receive either the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level RCT (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur at post-intervention (both trial stages), and at 6, 12, 24, 36, 48- and 60-months post-baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed effect models.Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programs should be deployed in school-based settings in Australia and beyond.

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Background: Indigenous youth worldwide are at greater risk of developing mental health concerns due to ongoing inequity and disadvantage. Digital mental health solutions are identified as a potential approach to improving access to mental health treatment for Indigenous youth, with evidence of acceptability and effectiveness beginning to emerge. Although collaborative design, development and evaluation is widely recognised as necessary to improving the acceptability of these tools, there is limited evidence to guide engagement of Indigenous youth in these processes. The objective of this scoping review is to map evidence regarding the collaborative involvement of Indigenous youth in the design and/or evaluation of digital mental health interventions. Methods: Scoping review methodology includes six stages, 1) identifying research question; 2) identifying relevant studies; 3) developing a study selection and data extraction method; 4) charting the data; 5) collating, summarising and reporting results. Additionally, Step 6) consultation, engages a male and female Indigenous health researcher in reviewing protocols, analysis and findings, enhancing credibility and ensuring findings are informed by Indigenous worldviews. Searches for relevant literature are undertaken in the following databases: EBSCOhost databases (Academic Search Premiere, Computer and Applied Science complete, CINAHL Plus with Full text, MEDLINE with full text, APA PsychArticles, Psychology and Behavioural Sciences collection, APA PsychInfo), PubMed, and Scopus. In addition, Infomit and Google (limited to the first 200 results) are searched for grey literature. All primary studies and grey literature in English that meet eligibility criteria are included. Data, including; study methods, methodologies, digital mental health program details, participant information and engagement and reporting processes are extracted and included for analysis. Data extraction variables are guided by the Consolidated Criteria for Strengthening Reporting of Health Research (CONSIDER statement). This statement provides a best practice checklist for reporting research involving Indigenous peoples. This scoping review protocol has been registered with Open Science Framework (available via osf.io/2nkc6).Discussion: To date, there are no reviews which critically analyse engagement of Indigenous youth in the development and evaluation of youth-specific digital mental health interventions. This review will aim to fill that gap and appraise alignment of current practice with best practice guidelines to inform future research. It will highlight appropriate strategies for the engagement of youth in collaborative processes, providing guidance for health practitioners, policy makers, and researchers working in the field of Indigenous youth and digital mental health.