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Introduction: 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 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 is to describe the methods that will be used to capture process evaluation data within this trial., Methods and Analysis: Using a hybrid type 1 design, a mixed-methods approach will be used with data collected in the intervention arm of the Future Proofing Study. Data collection methods will include semistructured interviews with school staff and study facilitators, automatically collected intervention usage data and participant questionnaires (completed by school staff, school counsellors, study facilitators and students). Information will be collected about: (1) how the intervention was implemented in schools, including fidelity; (2) school contextual factors and their association with intervention reach, uptake and acceptability; (3) how school staff, study facilitators and students 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., Ethics and Dissemination: Ethics approval was obtained from the University of New South Wales (NSW) Human Research Ethics Committee (HC180836; 21st January 2019) and the NSW Government State Education Research Applications Process (SERAP 2019201; 19th August 2019). Results will be submitted for publication in peer-reviewed journals and discussed at conferences. Our process evaluation will contextualise the trial findings with respect to how the intervention may have worked in some schools but not in others. This evaluation will inform the development of a model for rolling out digital interventions for the prevention of mental illness in schools., Trial Registration Number: ANZCTRN12619000855123; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377664&isReview=true., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 programmes. However, barriers to implementing and accessing these programmes 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 programmes. 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 randomised controlled trial targeting up to 10,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive 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 randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur 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 programmes should be deployed in school-based settings in Australia and beyond., Trial Registration: Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

Background: Cognitive control problems have been implicated in the etiology and maintenance of mental health problems, including depression, in adults. Studies in adolescents have been more equivocal, with some showing changes in cognitive control in adolescents with mental health problems, whereas others fail to show an association. This study examines whether adolescent mental health is associated with affective control, the application of cognitive control in affective contexts, which shows more protracted development than cognitive control. Methods: The present study investigated the association of cognitive and affective control with depressive symptomatology and self‐reported diagnostic history of mental health problems in adolescents. The study included 1929 participants (Mage = 13.89) from the Future Proofing Study (N = 6,388, 11–16 years), who completed affective (incl., affective stimuli) and/or cognitive (incl., neutral stimuli) versions of a working memory (backward digit‐span) and/or shifting (card‐sorting) task at least once within 3 weeks of assessing mental health. Results: Poorer working memory was associated with greater depressive symptomatology in adolescents (β = −0.06, p =.004), similarly across cognitive and affective control conditions (β = −0.02, p =.269). Adolescents with self‐reported diagnostic history of mental health problems had significantly poorer shifting ability in affective compared to cognitive control conditions (b = 0.05, p =.010), whereas for adolescents with no self‐reported diagnoses, shifting ability did not differ between conditions (b = −0.00, p =.649). Conclusions: The present analyses suggest that working memory difficulties, in particular, may be associated with the experience of current depressed mood in adolescents. Problems with affective shifting may be implicated in a range of mental health problems in adolescents. Given the ubiquitous need for efficient cognitive functioning in daily life, enhancing cognitive and affective control in adolescents may be a promising means of improving functioning across a range of domains, including affective functioning, and by extension, adolescent mental health. [ABSTRACT FROM AUTHOR]

Background: Depression is common during adolescence and is associated with adverse educational, employment, and health outcomes in later life. Digital programs are increasingly being implemented in schools to improve and protect adolescent mental health. Although digital depression prevention programs can be effective, there is limited knowledge about how contextual factors influence real-world delivery at scale in schools. Objective: The purpose of this study was to examine the contextual factors that influence the implementation of the Future Proofing Program (FPP) from the perspectives of school staff. The FPP is a 2-arm hybrid type 1 effectiveness-implementation trial evaluating whether depression can be prevented at scale in schools, using an evidence-based smartphone app delivered universally to year 8 students (13-14 years of age). Methods: Qualitative interviews were conducted with 23 staff from 20 schools in New South Wales, Australia, who assisted with the implementation of the FPP. The interviews were guided by our theory-driven logic model. Reflexive thematic analysis, using both deductive and inductive coding, was used to analyze responses. Results: Staff perceived the FPP as a novel ("innovative approach") and appropriate way to address an unmet need within schools ("right place at the right time"). Active leadership and counselor involvement were critical for planning and engaging; teamwork, communication, and staff capacity were critical for execution ("ways of working within schools"). Low student engagement and staffing availability were identified as barriers for future adoption and implementation by schools ("reflecting on past experiences"). Conclusions: Four superordinate themes pertaining to the program, implementation processes, and implementation barriers were identified from qualitative responses by school staff. On the basis of our findings, we proposed a select set of recommendations for future implementation of digital prevention programs delivered at scale in schools. These recommendations were designed to facilitate an organizational change and help staff to implement digital mental health programs within their schools. [ABSTRACT FROM AUTHOR]