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Background Self‐harm and suicide related behaviours are increasing in young people, and clinical support is not adequately meeting needs. Improved approaches to assessment and the clinical management of self‐harm will result from codesign processes and include greater shared decision‐making between young people and practitioners. The CaTS‐App (an adapted digital version of the existing Card‐Sort Task for Self‐harm research tool) aims to facilitate a collaborative understanding of adolescent self‐harm and support decision‐making within clinical settings. The codevelopment of a digital, clinical tool which meets the needs of multiple stakeholders requires careful consideration. Methods We present a case‐study describing the participatory aspects of the development of the CaTS‐App, which included comprehensive patient involvement, research activities and coproduction with diverse young people aged 17–24 with lived experience of self‐harm. We share our processes and activities to deliver safe, engaging, sustainable, ethical and responsible participatory practice and co‐created knowledge, in the codevelopment of the CaTS‐App. Results Activities spanned a 48‐month period in both face‐to‐face and online settings. Example processes and activities are provided in narrative, tabular and diagrammatic form, alongside discussion of the rationale for choices made. A summary methodology is also shared to stimulate continued discussion and development of participatory approaches in digital mental health. Conclusions The paper contributes important insight and practical detail for the delivery of genuine participatory processes in digital mental health development when working with a population who may be considered vulnerable. We discuss a case‐study and working methodology for meaningful, safe and responsible involvement in the early Planning and Discovery phase of the development of a novel assessment and intervention app for self‐harm—the CaTS‐App This paper contributes to important discussions about the process and value of centering and evaluating participatory processes in the development of digital mental health interventions for self‐harm.

IntroductionWhile digital technologies can increase the availability and access to evidence-based interventions, little is known about how users engage with them and the mechanisms associated with effective outcomes. Process evaluations are an important component in understanding the aforementioned factors. The ‘SPARX-UK’ study is a randomised controlled pilot and feasibility trial evaluating personalised human-supported (from an ‘eCoach’) vs a self-directed computerised cognitive behavioural therapy intervention (cCBT), called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), aimed at adolescents with mild to moderate depression. We are comparing supported vs self-directed delivery of SPARX to establish which format should be used in a proposed definitive trial of SPARX. The control is a waitlist group. We will conduct a process evaluation alongside the trial to determine how the intervention is implemented and provide context for interpreting the feasibility trial outcomes. We will also look at the acceptability of SPARX and how users engage with the intervention. This protocol paper describes the rationale, aims and methodology of the SPARX-UK trial process evaluation.Methods and analysisThe process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arms; purposively sampled, semi-structured interviews of adolescents, parents/guardians, eCoaches and clinicians/practitioners from the SPARX-UK trial; and analysis of qualitative comments from a survey from those who dropped out early from the trial. Quantitative data will be analysed descriptively. We will use thematic analysis in a framework approach to analyse qualitative data. Quantitative and qualitative data will be mixed and integrated to provide an understanding of how the intervention was implemented and how adolescents interacted with the intervention. This process evaluation will explore the experiences of adolescent participants, parents/guardians, eCoaches and clinicians/practitioners in relation to a complex digital intervention.EthicsEthical approval was granted by the National Health Service (NHS) Health Research Authority South West - Cornwall & Plymouth Research Ethics Committee (Ethics Ref: 22/SW/0149).DisseminationContextualising how the intervention was implemented, and the variations in uptake and engagement, will help us to understand the trial findings in greater depth. The findings from this process evaluation will also inform the decision about whether and how to proceed with a full randomised controlled trial, as well as the development of more effective interventions which can be personalised more precisely via varying levels of human support. We plan to publish the findings of the process evaluation and the wider project in peer-reviewed journals, as well as disseminate via academic conferences.Trial registration numberISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.

IntroductionPurrble, a socially assistive robot, was codesigned with children to support in situ emotion regulation. Preliminary evidence has found that LGBTQ+ youth are receptive to Purrble and find it to be an acceptable intervention to assist with emotion dysregulation and their experiences of self-harm. The present study is designed to evaluate the impact of access to Purrble among LGBTQ+ youth who have self-harmful thoughts, when compared with waitlist controls.Methods and analysisThe study is a single-blind, randomised control trial comparing access to the Purrble robot with waitlist control. A total of 168 LGBTQ+ youth aged 16–25 years with current self-harmful ideation will be recruited, all based within the UK. The primary outcome is emotion dysregulation (Difficulties with Emotion Regulation Scale-8) measured weekly across a 13-week period, including three pre-deployment timepoints. Secondary outcomes include self-harm (Self-Harm Questionnaire), anxiety (Generalised Anxiety Disorder-7) and depression (Patient Health Questionnaire-9). We will conduct analyses using linear mixed models to assess primary and secondary hypotheses. Intervention participants will have unlimited access to Purrble over the deployment period, which can be used as much or as little as they like. After all assessments, control participants will receive their Purrble, with all participants keeping the robot after the end of the study. After the study has ended, a subset of participants will be invited to participate in semistructured interviews to explore engagement and appropriation of Purrble, considering the young people’s own views of Purrble as an intervention device.Ethics and disseminationEthical approval was received from King’s College London (RESCM-22/23-34570). Findings will be disseminated in peer review open access journals and at academic conferences.Trial registration numberNCT06025942.