4. Discussion
RECRUITMENT
The recruitment of participants for the ME-WE trial study has certainly proved that AYCs are a hard-to-reach target group for researchers and practitioners. A lower number of participants were recruited and fully engaged, despite the significant recruitment efforts that were made and additional efforts spent. In order to approach AYCs and ask them to participate in the study, the first challenge was to identify them in the general population. This task was carried out in partnership with local non-profit organisations, as well as institutional services such as schools and social care. In addition, recruitment campaigns (e.g., through social media) were implemented in some cases, targeting children and young people. Since in most countries the phenomenon of AYCs Is not formally recognised and both practitioners have low awareness about this target group and AYCs themselves have low self-awareness of their role, there was a need to train field workers about the issue and to understand with them the best channels to exploit for recruitment. The identification of AYCs was difficult due to all these factors and resulted in a limited number of AYCs being approached (n = 478, 90.9% of the total target sample size) and involved in the study after screening, compassionate cases and withdrawals (n = 260, 49.4% of the total target sample size).The second challenge was to keep AYCs interested while waiting for their ME-WE group to start and subsequently to keep them engaged in the study until the end. Despite a high retention rate (82% of those starting the study), a further reduction (18%) in AYC cases available for the quantitative analysis occurred, leading to a total final number of 217 cases (41.3% of the total target sample size). However, in some countries there was a higher number of dropouts (especially in Slovenia and the UK), which suggests that specific problems were faced during the intervention implementation. The need to fill in online surveys with a relatively large battery of sensitive questions might have deterred some AYCs from participating in the evaluation. Furthermore, the long waiting period of 3 months after the end of the intervention may have contributed to reducing the AYCs motivation to complete the questionnaire at T2.Overall, the ME-WE trial study was conducted in specific and highly challenging times under COVID-19 restrictions of physical and social distancing and periodic lockdowns in most participating countries. The COVID-19 restrictions led to a temporary complete halt of the recruitment process in all six countries, thus leaving partners to endorse social media campaigns (Switzerland, Sweden), which were based on an individual recruitment strategy. The delivery of the intervention itself was severely hindered by the outbreak of the COVID-19 pandemic, as the Netherlands and Slovenia were in the field during the first lockdown period that affected Europe. The intervention was moved fully online; however, there was a long pause in Slovenia, for example, in waiting for all intervention materials to be adjusted to an online delivery, which resulted in increased dropout rates. Due to the transition to online platforms during lockdown, some participants were unable to continue participating owing to technical barriers (see the ethical considerations below). The recruitment barriers prevented partners from reaching sufficient sample sizes and, consequently, it was not feasible to perform a complete quantitative analysis both at the national level as well as the cross-national level.The restricted age group (15–17 years) that was targeted could have been another limiting factor to identifying AYCs. Minors in this group are in a transition phase of their personal development from childhood to adulthood and may be subject to a variety of social influences (e.g., perceived social stigma of attending a psychosocial support intervention), as well as practical constraints (e.g., limited time to attend the intervention sessions due to school, family and social and care commitments). Moreover, as AYCs are more likely to come from socially disadvantaged groups, family circumstances and other issues may have prevented some from joining in and finding sufficient time and resources to dedicate to such a project.Moreover, in general, the study design of interventions such as the one proposed by the ME-WE project deserves careful consideration. RCTs are widely used in medical and health-related research, especially for drug discovery and efficacy evaluation, but their use in social research with psychosocial interventions such as the ME-WE intervention are far less common. The reasons include ethical considerations but also practicalities of the process and how to conduct rigorous (reliable) RCTs in social/community settings with a “hard to reach” and invisible group such as AYCs, where professionals and other gatekeepers have little awareness of the “target group” [Despite recruitment challenges and study limitations (some explained also in Hanson and colleagues [As a result of the impact of the COVID-19 pandemic on the study, the ME-WE intervention model, which was originally designed for a face-to-face approach and a blended face-to-face and app approach, was shown to be adaptable and well functioning in a fully online approach [The mixed-methods evaluation ultimately implemented relies on a robust and sufficient amount of quantitative and qualitative data. These latter ones suggest some evidence of promising results that can shape future interventions and further research in this field. Although, due to several methodological limitations, the data should be interpreted with caution, the results suggest some positive impacts. Despite all the challenges faced in the course of the project, the ME-WE model provided a benefit to the mental health and overall well-being of the AYCs, as expressed by the AYCs through their own first-hand accounts. 