| Item | Description | Manuscript |
| 1. Report the context for which the intervention was developed. | Understanding the context in which an intervention was developed informs readers about the suitability and transferability of the intervention to the context in which they are considering evaluating, adapting or using the intervention. | “It is essential for the intervention development process to be reported as this can enhance our theoretical and practical understanding about developing mental health interventions for male students [25]”. In response to this, the current paper seeks to develop the first framework for developing and designing mental health interventions for male students that is grounded in evidence-based practice. |
| 2. Report the purpose of the intervention development process. | Clearly describing the purpose of the intervention specifies what it sets out to achieve. The purpose may be informed by research priorities, for example those identified in systematic reviews, evidence gaps set out in practice guidance, such as the NICE, or specific prioritisation exercises. | “The MRC framework for developing and evaluating complex interventions will be used with the Behaviour Change Wheel to develop a framework for new interventions that address help-seeking in male students. It is anticipated that this framework will create a starting point for future interventions which can be refined as the current evidence base is enriched. Furthermore, specific detail in accordance to the Guidance for Reporting Intervention Development Studies in Health Research (GUIDED) checklist has been included (Appendix A) to further enrich the quality of evidence that is reported within the current paper [25].” |
| 3. Report the target population for the intervention development process. | The target population is the population that will potentially benefit from the intervention–this may include patients, clinicians and/or members of the public. If the target population is clearly described, then readers will be able to understand the relevance of the intervention to their own research or practice. Health inequalities, gender and ethnicity are features of the target population that may be relevant to the intervention development process. | “In response to this, the current paper seeks to develop the first framework for developing and designing mental health interventions for male students that is grounded in evidence-based practice.” |
| 4. Report how any published intervention development approach contributed to the development process. | Many formal intervention development approaches exist and are used to guide the intervention development process. Where a formal intervention development approach is used, it is helpful to describe the process that was follows, including any deviations. | “This paper will discuss the development of an intervention using a published approach grounded in theory and evidence base by combining published research evidence and existing theories [27]. The MRC framework for developing and evaluating complex interventions will be used with the Behaviour Change Wheel to develop a framework for new interventions that address help-seeking in male students.” |
| 5. Report how evidence from different sources informed the intervention development process. | Intervention development is often based on published evidence and/or primary data that have been collected to inform the intervention development process. It is useful to describe and reference all forms of evidence and data that have informed the development of the intervention because evidence bases can change rapidly, and to explain the manner in which the evidence and/or data were used. | “This paper will discuss the development of an intervention using a published approach grounded in theory and evidence base by combining published research evidence and existing theories [27].”This paper also incorporates published systematic reviews and qualitative findings from focus groups into the development of the intervention throughout the paper. |
| 6. Report how/if existing published theory informed the intervention development process. | Reporting whether and how theory informed the development process aids the reader’s understanding of the theoretical rationale that underpins the intervention. This can relate to either existing published theory or programme theory. | This is utilised throughout the paper. The paper draws upon published evidence from systematic reviews, qualitative findings from focus groups and theory informed research structured within the ‘access to care model’. |
| 7. Report any use of components from an existing intervention in the current intervention development process. | Some interventions are developed with components that have been adopted from existing interventions. Clearly identifying components that have been adopted or adapted and acknowledging their original source helps the reader to understand and distinguish between the novel and adopted components of the new intervention. | “Sagar-Ouriaghli and colleagues [22] identified 18 BCTs (e.g., credible source, feedback on behaviour and problem solving), which were in turn synthesised into broader, more clinically relevant, psychological processes that are likely to contribute to changes in help-seeking for men of different age groups (Appendix B). These seven key processes include: the use of role models (e.g., celebrities and other men) to convey information, psycho-educational materials to improve mental health knowledge, assisting men to recognise and manage their symptoms, adopting active problem solving and/or solution focused tasks, motivating behaviour change, sign-posting mental health services and finally, including content to build on positive masculine traits (e.g., responsibility and strength).” |
| 8. Report any guiding principles, people or factors that were priorities when making decisions during the intervention development process. | Reporting any guiding principles that governed the development of the intervention will help the reader to understand the authors’ reasoning behind the decisions that were made. Guiding principles specify the core objectives and features of the desired intervention. | “Lastly, not all intervention functions should be implemented, and should be chosen based on their affordability, practicability, effectiveness/cost-effectiveness, acceptability, side-effects/safety and equity–otherwise known as the APEASE criteria [103]. … Once all potential BCT’s have been identified, the APEASE criteria is used once more to determine which specific techniques or tools are most appropriate. Additionally, BCT’s that have been frequently used before in similar interventions may also aid in this decision [22,103].” |
| 9. Report how stakeholders contributed to the intervention development process. | Potential stakeholders can include patient and community representatives, local and national policy makers, healthcare providers, and those paying for or commissioning healthcare. Each of these groups may influence the intervention development process in different ways. | The intervention development outlines how the theory informed components are also based on focus group findings from the potential service users of a male-student intervention for mental health help-seeking. |
| 10. Report how the intervention changed in content and format from the start of the intervention development process. | Due to the iterative nature of intervention development, the intervention that is defined in the end of the development process can often be quite different from the one that was initially planned. Describing these changes and their rationale enhances understanding and enables understanding other intervention developers to learn from this experience. | This is not applicable to the current paper. Here, the current paper outlines key factors that are likely to be important that can be used as a template/framework for future interventions. In the instance that interventions are developed following this framework, any changes to the intervention/deviation from the proposed framework should be reported here. |
| 11. Report any changes to interventions required or likely to be required for subgroups. | Specifying any changes that the intervention development team perceive are required for the intervention to be delivered or tailored to specific subgroups enables readers to understand the applicability of the intervention to their target population or context. | This is not applicable to the current paper. Here, the current paper seeks to provide a broad overview of the factors which are likely to be effective when designing mental health interventions for male students. Therefore, broad intervention strategies are outlined. If a more specific sub-group of male students is the focus of a newly proposed intervention this should be stated in future work. |
| 12. Report important uncertainties at the end of the intervention development process. | Intervention development is frequently an iterative process. The conclusion of the initial phase of intervention development does not necessarily mean that all uncertainties have been addressed. It is helpful to list remaining uncertainties, such as the intervention intensity, mode of delivery, materials, procedures or type of location that the intervention is most suitable for. This can guide other researchers to potential future areas of research and practitioners about uncertainties relevant to their healthcare context. | “Subsequently, the recommendations may not directly transfer to male-students. Indeed, younger adults are significantly less likely to seek help and hold more negative help-seeking attitudes [107,108], whilst students are also faced with barriers which may differ from non-students and older adult males. In an attempt to provide a comprehensive overview, the current paper is unable to provide more specific recommendations for sub-groups of male students. For instance, sexual minority male students or male students from ethnic minority backgrounds face different barriers and it is likely that they will need more tailored interventions to accommodate their needs and encourage help-seeking [109,110,111,112]. Lastly, this framework is yet to be implemented when designing future male-student help-seeking interventions. Although this paper synthesises evidence-based work specifically for men and male students, it is unclear as to how transferable and applicable this will be to real world scenarios. Indeed, it would be valuable to see how effective/ineffective this framework is for others developing mental health interventions for male students.” |
| 13. Follow TIDieR guidance when describing the developed intervention. | Interventions have been poorly reported for a number of years. In response to this, internationally recognised guidance has been published to support the high-quality reporting of healthcare interventions and public health interventions. This guidance should therefore be followed when describing a developed intervention. | This is not applicable to the current paper as it does not report a specific intervention, nor does it pilot the described intervention. However, the current paper recommends the use of TIDieR when interventions are designed in accordance to this framework. Furthermore, newly developed interventions should be reported in accordance to the Template for Intervention Description and Replication (TIDieR) checklist to aid with replication and clarity of the final intervention [22,33].” |
| 14. Report the intervention development process in an open access format. | Unless reports of intervention development are available, people considering using an intervention cannot understand the process that undertaken and make a judgement about its appropriateness to their context. It also limits cumulative learning about intervention development mythology and observed consequences at later evaluation, translation and implementation stages. Reporting intervention development in an open access publishing format increases the accessibility and visibility of intervention development research and makes it more likely to be read and used. | The current paper was submitted and published in open access format in the International Journal of Environmental Research and Public Health (IJERPH). |