Background and rationale {6a}
Current data indicates that 16% of 5–16-year-olds experience mental health difficulties (MHDs). These difficulties, defined as enduring, maladaptive changes in thoughts, feelings, and/or behaviour, impair quality of life and are concurrently and prospectively associated with academic attainment and other salient outcomes [1]. Children with MHDs are more likely to experience social difficulties later in childhood, higher rates of mental health difficulties in adolescence, and perform poorer in exams at age 16 years compared to their same aged peers [2]. The transition from childhood to adolescence (between 9–11 years) appears to be crucial, given the occurrence of major physical, psychological, and social changes in this period [3]. Half of all lifetime mental disorders emerge by age 14 years and 75% by age 24 years [4], and there is a clear increase in the prevalence of mental health difficulties from childhood to adolescence [5]. Common MHDs that emerge in this developmental phase include an increase in internalising symptoms, characterised by a disturbance in mood or emotion, such as depression and anxiety [6, 7]. In particular, there is a marked increase in internalising symptoms among girls [5, 8]. Loneliness is also highly prevalent in early adolescence, with data suggesting that loneliness in middle childhood precedes depression in adolescence [9] and can predict other later MHDs [10].
Universal school-based prevention programmes: the role of social and emotional learning in alleviating internalising symptoms
Improving understanding of the role that schools can play in promoting mental health and reducing loneliness and related MHDs is a current national [11] and global [12] public health priority. Their wide reach, prolonged period of engagement, and central role in communities make schools ideal settings in which to implement universal interventions to prevent the development, maintenance, or escalation of MHDs among children and young people (CYP) [13].
Universal school-based interventions target all children regardless of level of difficulties or risk and align with the public health approach to mental health promotion within the UK. They are potentially more cost-effective than targeted/indicated approaches, may serve to reduce stigma, and, critically, can influence outcomes for CYP who would not otherwise access the support they need through usual care pathways [14]. Such an approach also aligns with the UK Government’s Loneliness Strategy, with a focus on creating connected (school) communities [15]. Universal school-based social and emotional learning (SEL) interventions aim to develop the social and emotional skills of all CYP through explicit instruction in the context of learning environments that are safe, caring, well-managed, and participatory [14]. The Collaborative for Academic, Social and Emotional Learning (CASEL) defines social-emotional competence in terms of five broad and interrelated skills: self-awareness, self-management, social awareness, relationship skills, and responsible decision-making [16]. Within the domain of self-management, emotion regulation is particularly important in preparing young people to cope with a wide range of stressors and challenges in daily life [17]. Crucially, as learning is a social process, it makes sense that the range of SEL skills can also support academic success (via, for example, improving engagement in the classroom) [14]. In the longer term, studies highlight the predictive utility of childhood social and emotional competencies for mental and social health and labour market outcomes in later life [18].
Meta-analytic evidence demonstrates the effectiveness of universal, school based SEL interventions in producing meaningful improvements in a range of salient outcomes related to mental health and well-being [19]. They have been shown to reduce internalising symptoms (effect size (ES) d/g = 0.19–0.24) [17, 19], with emergent evidence of sustained effects [20]. Furthermore, there is tentative evidence that they can reduce loneliness [21]. Because data suggests that children with internalising symptoms often show poorer social skills and emotional regulation capacities, acquiring such skills early has considerable utility, especially at a time when they are emerging and not yet trait-like or habitual. A universal intervention implemented as children become adolescents may be particularly beneficial to reduce many lifetime cases of MHDs that begin during adolescence [7].
Passport
Passport is a universal SEL intervention for 9–11-year-olds. The principal aim of the programme is to increase children’s abilities to cope with everyday difficulties by developing positive coping strategies. Each session is based around a comic strip that follows the adventures of two children and a friendly dragon. Children develop their own positive strategies to deal with problems through engaging activities: reading the comic strips, discussion, role play, and games [22]. Passport exemplifies the principles of SEL interventions by helping children to learn, expand, and consolidate their repertoire of social and emotional skills, enabling them to navigate more specific interpersonal difficulties such as bullying and stressful daily challenges.
Passport has a theoretical basis in coping theory [22] and aims to nurture coping flexibility by teaching a range of coping strategies. Coping flexibility involves the abilities to monitor and evaluate coping strategies, discontinue an ineffective strategy, and implement an alternative strategy that meets situational demands [23, 24]. Coping flexibility is associated with fewer mental health difficulties, particularly internalising symptoms [23, 24]. It is hypothesised to manifest through the initiation of more effective emotion regulation (defined as the processes involved in modifying the intensity, quality, duration, speed of elicitation, and recovery of emotional states in service of adaptation in situations that trigger unwanted feelings [25]). The negative cycle between difficulties with emotional regulation and the increase in unwanted feelings that is proposed to underpin the development of internalising symptoms [24] is therefore disrupted before it becomes consolidated and habitual. Delivering Passport during the transition from childhood to adolescence may therefore be a developmentally optimal strategy for nurturing resilience across the lifespan since it targets children just prior to the stage in which most MHDs emerge [4]. An association between emotion regulation and internalising symptoms in the transition to adolescence has been established empirically [26, 27] but it has not been established whether it is amenable to intervention.
There is an emerging evidence base for Passport. A small, developer-led trial in Canada demonstrated the feasibility (e.g., implemented as planned), acceptability (e.g., children enjoyed the comic strip format, high level of teacher appreciation of training in delivering intervention), and utility (e.g., improved coping and social skills) of the intervention, providing preliminary qualitative and quantitative evidence for the perceived mechanisms of a greater repertoire of coping strategies [28]. However, there is no independent evidence of Passport’s efficacy. In England, it is currently being phased into the education system by the Partnership for Children (and implemented in 115 schools to date). A robust, independent trial is, therefore, extremely timely.
While the SEL evidence base is well-advanced with respect to the basic question of ‘what works’, there is much still to learn, particularly in relation to: how and why interventions work (change mechanisms underpinning outcomes and implementation moderator effects) [19, 29]; for whom interventions work best (subgroup moderator effects) [13, 19] when interventions work (timing of effects, including both maintenance and sleeper effects) [13, 19]; the range of outcomes for which interventions work (scope) [13]; and at what cost they work [30]. Also required is further understanding of the cultural transferability of programmes and whether interventions can be effective when transported outside of their culture of development. Additionally, there is a need to extend the SEL evidence base beyond interventions implemented in the initial years of the primary school phase, from which much of the existing evidence is drawn [19].
Objectives {7}
The trial’s objectives are as follows:
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1.
To examine the impact of Passport on children’s internalising symptoms at post-intervention in schools implementing the intervention compared to those implementing the usual school curriculum (primary outcome).
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2.
To determine the impact of Passport on a range of related outcomes, namely, emotional regulation, well-being, loneliness, bullying, peer support, and academic attainment (secondary outcomes), post-intervention in schools implementing the intervention compared to those implementing the usual school curriculum. Academic attainment will be assessed at 12-month post-intervention follow-up only (i.e., 24 months post-baseline).
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3.
To establish whether any intervention effects for primary and secondary outcomes are sustained at 12-month post-intervention follow-up (or emerge at 12-month follow-up, in the case of null impact at post-intervention).
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4.
To ascertain the cost-effectiveness of Passport.
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5.
To examine whether intervention effects vary by levels of implementation (specifically, dosage).
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6.
To examine whether primary intervention effects are mediated by changes in emotional regulation.
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7.
To determine whether low emotional regulation skills at baseline moderate primary intervention effects.
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8.
To investigate whether Passport is implemented as intended by the developer and what factors influence implementation.
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9.
To explore the perceptions and experiences of school staff and children in delivering and engaging with Passport.
Trial design {8}
A two-arm (intervention vs. control) parallel cluster randomised controlled trial design, incorporating a mixed-methods implementation and process evaluation (IPE), will be used. Schools will be the unit of randomisation. Random allocation will take place following completion of baseline measures (T0), with minimisation ensuring balance across trial arms in school size and the proportion of children eligible for free school meals (FSM). This trial will follow a superiority framework (i.e., we hypothesise that the intervention is superior to usual practice).
Schools allocated to the intervention arm will implement Passport to Year 5 classes in the academic year 23/24. Implementing teachers will receive initial training followed by a booster session during the school term. Schools allocated to the control arm will continue to deliver the usual school curriculum. Child-level outcomes will be assessed annually at baseline (T0), post-intervention (T1), and 12-month post-intervention follow-up (T2).
The IPE will include a qualitative strand comprising case studies of 5 purposively sampled intervention schools (to include interviews with teaching staff and members of the senior leadership team alongside pupil focus groups), and a quantitative strand comprising teacher surveys focusing on usual practice in promoting SEL, outcomes (such as stress), and implementation (among those in intervention schools).
Patient and Public Involvement (PPI)
PPI will be led by our colleagues at Common Room, with representatives sitting in our wider project team, and input from their young research advisors (YRA), who are young people with an interest in supporting research around children and young people’s mental health and well-being, particularly around the influence of social media and school support. Collaboration with Common Room YRA enables this research to benefit from young people’s participation and involvement across the trial. Public involvement in research has been associated with improvements in research design and delivery, recruitment strategies and materials, and data collection tools [31]. Prior to data collection, Common Room YRA will meet with the research team, providing valuable perspectives on the process, presentation, and evaluation of qualitative and quantitative data generation approaches (e.g., look and feel of online surveys), and how key processes are experienced and consented to (e.g., ensuring that the data burden of the survey is acceptable). YRA are helpful in effectively gathering information and insight from target groups of other young people to make sure the supporting processes and relevant information are accessible and meaningful (e.g., ensuring that participant information and assent process is accessible to CYP). Common Room representatives will also provide support with creative ways of disseminating our findings to improve impact and consulting with other stakeholder groups (e.g., teachers) as appropriate. They provided input in meetings that focused on the development and final review of this protocol.
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