Supporting the Mental Health of Children through Stix Innovation: A Feasibility Trial

Research question: Is it feasible to conduct a definitive efficacy trial of mindfulness skills training for children using Stix (www.Stixmindfulness.co.uk), an engaging screen-free handheld device to guide through mindfulness exercises, to improve the mental health of 8-10 year-old children? Background: Approximately 70% of mental illnesses (MIs) originate before 16 years. Pre-adult onset of MIs predicts worse clinical and functional outcomes across the life span. It is thus crucial to intervene early to reduce the risk of MIs in childhood. One way to potentially achieve this is by teaching children mindfulness skills using a programme that is sufficiently engaging without extensive screen use and supported by robust evidence, but no such programme currently exists for young children. Stix, which has been co-designed with children, may fill this gap. Stix has two handheld devices (remotes) with a built-in voice that guides the children through mindfulness exercises, and a supporting app for progress tracking and age-appropriate rewards to encourage ongoing practice. Aims and objectives: We aim to examine the feasibility and acceptability of a future definitive trial to determine Stix’s potential for supporting children’s mental health. Specifically, we will determine feasibility of participant recruitment and willingness to be randomised, and acceptability of Stix, as the primary objectives. Further, we will explore practicality of Stix training in a home setting; contamination (control arm); suitable methods for measuring the intervention effect; retention and follow-up rate; and acceptability of outcome data collection. Methods: Work package (WP) 1: We will study 60 8–10-year-old children who have been identified by pastoral care as in need of individualised support at participating schools. Of these, 30 children will be randomly allocated to 6-week Stix-based mindfulness training (intervention), and 30 children will continue with standard care (control). All children will be assessed before randomisation, at 6 weeks and 12 weeks post randomisation. Control arm children will be offered the Stix-based training after their participation ends. WP2: Qualitative data from the parents/caregivers, children, and relevant school staff will be gathered via semi-structured interviews and undergo thematic analysis using a framework approach to explore intervention acceptability and their experience of and barriers to trial participation. WP3: Design and development of the future definitive trial integrating stakeholder engagement with findings from WPs 1-2. Timelines: Ethics approval: month 1; WPs 1-2 by month 18, WP3 by month 21; dissemination and the future trial developed by month 24. Knowledge mobilisation, dissemination and impact: This project will result in a comprehensive protocol for a future definitive trial. Study protocols will be preregistered and open, and FAIR principles for research reproducibility will be followed. In PPI work we have learnt that schools, child welfare charities, and healthcare communities are central to successful dissemination and Stix implementation. Therefore, apart from publishing in academic journals, we will share our findings with the wider public as per the plan developed with the PPIE group and Brunel Public Policy unit. Research inclusion: Our sampling approach, recruitment strategies, accessibility of study materials, data collection methods, and PPIE will ensure research inclusiveness.