Clinical trial to evaluate a digital self-management and mental health intervention for young people with asthma and their families

A randomised controlled trial of our Asthma AI+ smartphone application, comparing the AI+ features (Arm 1 – AI+ symptoms) to the symptom tracking only features (Arm 2 (control) – Symptoms). Intervention participants will be provided with a copy of a workbook along with the smartphone app. Content development - Evidence-based content for use in the intervention platform (AI+ symptoms) will be produced to provide: a. Education for young people with asthma and their families on understanding asthma how to recognise triggers, build coping skills for asthma exacerbations and other educational content aligned with national asthma guidelines, b. Education for young people with asthma and families of children under 18 years of age, on understanding mental health and wellbeing, and how to build coping skills for symptoms of psychological distress associated with asthma,(e.g., symptoms of anxiety and depression), c. Self-management skill development for asthma, informed by an individually tailored written action plan entered by the individual, or one developed in-app based on the individual’s data inputs and app interactions. This includes instructional videos on correct asthma inhaler technique, how to avoid triggers and manage exacerbations, and other best practice self-management strategies according to national asthma guidelines, d. Psychologist delivered activities (via instructional videos and written content, interactive games, and self-help skill development modules), to support patients to self-manage episodes of psychological distress, build resilience and coping skills when experiencing flare-ups and to prevent worsening of symptoms, e. 80-page downloadable workbook delivering written content, activities, and skill development for asthma and mental health/wellbeing, to supplement the digital intervention content. This will be developed based on best-practice asthma guidelines and through consultation with field experts in Psychology and Paediatric Respiratory Medicine. (Intervention participants will be provided with a copy of the workbook along with the smartphone app, while control group participants will only have access to the smartphone app for self-management.) The AI and machine-learning algorithms proposed for this project utilise Just in Time Adaptive Intervention (JITAI) methodology, which allows content to be delivered at the right time for the user. The AI component will not interact with the user like other available AI programs, but instead will examine the user’s content usage, for example self-education modules, and deliver these when they are likely to be most useful to the user. This, along with gamification strategies, should encourage users to engage with the platform and get the most value from the content available. Participants will be able to access and continue using the app to which they were randomised past the 12-week follow-up to 12 months, with questionnaires repeated periodically as per outcomes for the purposes of hypothesis generation and longitudinal follow-up. The app is to be used at the participants' discretion. App use data will be forwarded to researchers. The participant's parents/carers will also have access to a portal through which they can access content to help them care for a child with asthma, and, depending on age of the participant, will receive high level notifications when their child's data reflects that they are struggling with symptom management (either asthma or mental health).