Title: Youth Metacognitive Therapy (YoMeta): A Single Blind Parallel Randomised Feasibility Trial
Funder: Department of Health and Social Care

Abstract: Research Question: Is a future large scale parallel randomised trial of group metacognitive therapy (MCT) for children and young people (CYP) with common psychological problems acceptable and feasible? Background: The 2017 NHS report on mental health in CYP found that 12.8% of 5 to 19 year olds had at least one mental health disorder, with one in twenty meeting criteria for more than one disorder, highlighting that comorbidity is common (1,2). CYP mental health problems impact on the individual, family, schools and society. Reviews of the efficacy of evidence-based treatments for common mental health problems in CYP show limited efficacy. As such, alternative and potentially more effective treatments are needed. A potential solution is to offer treatment that targets common or transdiagnostic mechanisms that cause a wide range of mental health disorders. One such approach is MCT, which has established efficacy in adult mental health, but so far has not been evaluated in a randomised trial of CYP. Aims and Objectives: To assess the feasibility and acceptability of the delivery of the intervention (MCT) under randomised trial conditions and over time. Our objectives are to assess the variability and acceptability of primary and secondary outcome measures, obtain data from which a sample size can be calculated for a definitive trial, obtain data on adherence to the treatment manual, and qualitative data on patient participation that can clarify training and supervision needs. In addition, we will obtain preliminary economic data to inform the optimum way of evaluating cost-effectiveness. Methods: Study 1 is a single blind parallel randomised feasibility trial with two conditions: group MCT vs. treatment as usual (TAU) with a minimum of 80 children (40 per arm) aged 8-16 seeking treatment for anxiety disorders, stress disorders and/or depression. MCT will consist of 8 group-based sessions. Participants will be assessed at four time-points: pre-treatment (baseline), 16 weeks (post-treatment) and at two follow-up points (28 weeks and 40 weeks from baseline). The primary outcome, the Revised Child Anxiety and Depression Scale- Short Version (RCADS-S), and a range of secondary outcomes will be administered at each time-point. Study 2 is a nested qualitative study that will evaluate CYPs experiences of group MCT and being involved in the trial, as well as clinicians experiences of training in and delivery of MCT. Preliminary health economic data will be collected to estimate potential cost-effectiveness. Timelines: The study will take 36 months: 6 months set-up, 20 months for recruitment, treatment delivery and follow up, and the remaining for analysis and dissemination Impact and Dissemination: The study will generate data to inform the design of a definitive trial by providing data for a power and sample size estimation, feasibility of recruitment and the acceptability of the trial/intervention. Researchers, patients and clinicians will benefit from the study as it offers preliminary information for a subsequent trial, and the potential for improved outcomes that can benefit service users and clinicians. Results will be disseminated via peer-reviewed journals, national and international conferences and service user/voluntary sector organisations and networks.

Lay abstract: Background: One in eight children and young people (CYP) suffer mental health problems needing support or treatment and 5% have more than one such problem (1). The effects can be major, affecting CYP emotionally and functionally, impacting progress at school, relationships with others and increasing long term risk of mental health problems. Parents, schools, policy makers and the NHS often struggle to find the best way to help, especially within their limited budgets. The UK Government and the NHS have highlighted the need to improve mental health in CYP. The most common treatment is cognitive behavioural therapy; however this can be time consuming, needs to be delivered over many weeks, must focus on the most upsetting problem first and is not very effective. One way to overcome this is to evaluate a group therapy that can treat multiple mental health problems at once. This new treatment is called Metacognitive Therapy (MCT). Aim: The aim of the study is to see if participating in a randomized trial of Group MCT is a feasible and acceptable treatment for CYP suffering with anxiety, stress, depression, or a combination in comparison to usual care. This allows us to test key questions about recruitment and drop-out rates, test the protocol, and gain information about MCT including training and supervision needs of clinicians and the experience of patients receiving it. Design and Methods: We plan to recruit 100 participants (which allows for drop-outs) to obtain an overall minimum sample of 80 participants with anxiety, stress, depression or a combination. They will be randomised to one of two groups; group MCT or treatment as usual. Group MCT will be delivered across 8 sessions lasting 90 minutes. All participants will complete questionnaires at baseline, 16 week follow up (post treatment), 28 week follow up and 40 week follow up. A qualitative study will explore participants experience of group MCT and therapist views of MCT and being trained in MCT. Patient and Public Involvement: We have run focus groups with parents who have helped us to develop the research aims and design the research project. Throughout the project our PPI group (which will include children with lived experience) will co-develop study materials, advise on recruitment and retention of participants during follow up, and dissemination of study findings. Impact: The study impacts children, parents, teachers, researchers, clinicians, and the community. Findings will be publicised across a variety of outlets to ensure maximum outreach including conferences (local, international), peer-review publications, social media use, and workshops for teachers, parents, and CYP at schools. The research team will build on its proven track record of developing effective psychological interventions for anxiety and depression in mental and physical health and integrating these into services.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH