Emotion regulation in children (ERiC): A protocol for a randomised clinical trial to evaluate the clinical and cost effectiveness of Mentalization Based Treatment (MBT) vs Treatment as Usual for school-age children with mixed emotional and behavioural difficulties

PLOS ONE STUDY PROTOCOL a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 OPEN ACCESS Citation: Midgley N, Mortimer R, Carter M, Casey P, Coffman L, Edbrooke-Childs J, et al. (2023) Emotion regulation in children (ERiC): A protocol for a randomised clinical trial to evaluate the clinical and cost effectiveness of Mentalization Based Treatment (MBT) vs Treatment as Usual for school-age children with mixed emotional and behavioural difficulties. PLoS ONE 18(8): e0289503. https://doi.org/10.1371/journal. pone.0289503 Editor: Vanessa Carels, PLoS ONE, UNITED STATES Received: July 10, 2023 Accepted: July 17, 2023 Published: August 17, 2023 Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: https://doi.org/10.1371/journal.pone.0289503 Copyright: © 2023 Midgley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Emotion regulation in children (ERiC): A protocol for a randomised clinical trial to evaluate the clinical and cost effectiveness of Mentalization Based Treatment (MBT) vs Treatment as Usual for school-age children with mixed emotional and behavioural difficulties Nick Midgley ID1,2*, Rose Mortimer1,2, Mark Carter3, Polly Casey ID1,2, Lisa Coffman4, Julian Edbrooke-Childs1,2, Chloe Edridge1,2, Peter Fonagy1,2, Manuel Gomes2, Anoushka Kapoor1,2, Susannah Marks5, Peter Martin ID2, Bettina Moltrecht1,2, Emma Morris1,2, Nikola Pokorna1,2, Tara McFarquhar ID1,2,6 1 The Anna Freud Centre, London, United Kingdom, 2 University College London, United Kingdom, 3 Barnet, Enfield and Haringey NHS Trust, United Kingdom, 4 Barnet Parent/Carer Forum, United Kingdom, 5 Oxford Health NHS Foundation Trust, United Kingdom, 6 University of East Anglia, Norwich, United Kingdom * Abstract Background The majority of children referred to Child and Adolescent Mental Health Services (CAMHS) in the UK will present with mixed emotional and behavioural difficulties, but most mental health treatments are developed for single disorders. There is a need for research on treatments that are helpful for these mixed difficulties, especially for school-age children. Emotion Regulation (ER) difficulties present across a wide range of mental health disorders and mentalizing may help with regulation. The ability to mentalize one’s own experiences and those of others plays a key role in coping with stress, regulation of emotions, and the formation of stable relationships. Mentalization Based Therapy (MBT) is a well-evidenced therapy that aims to promote mentalization, which in turn increases ER capacities, leading to decreased emotional and behavioural difficulties. The aim of this study is to test the clinicaland cost-effectiveness of MBT compared to treatment as usual for school age children with emotional and behavioural difficulties. If effective, we hope this approach can become available to the growing number of children presenting to mental health services with a mix of emotional and behavioural difficulties. Materials and methods Children referred to CAMHS aged 6–12 with mixed mental health problems (emotional and behavioural) as primary problem can take part with their parent/carers. Children will be PLOS ONE | https://doi.org/10.1371/journal.pone.0289503 August 17, 2023 1 / 23 PLOS ONE Data Availability Statement: Deidentified quantitative research data will be made publicly available when the study is completed and published. Funding: - NM, PM, BM, MG, JEC, MC, SM, EM, PF and LC received the grant award for this project - Grant number: Kavli2021-0000000090 - Funder name: The Kavli Trust - Funder website: https:// kavlifondet.no/en/ - The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Emotion regulation in children (ERiC): A protocol for mentalization based treatment for school-age children randomly allocated to receive either MBT or treatment as usual (TAU) within the CAMHS clinic they have been referred to. MBT will be 6–8 sessions offered fortnightly and can flexibly include different family members. TAU is likely to include CBT, parenting groups, and/or children’s social skills groups. Parent/carers and children will be asked to complete outcome assessments (questionnaires and tasks) online at the start of treatment, mid treatment (8 weeks), end of treatment (16 weeks) and at follow up (40 weeks). Trial registration Clinical trial registration: ISRCTN 11620914. Competing interests: The authors have declared that no competing interests exist. Introduction In 2021, one in six (16.0%) children in England aged 5 to 16 were identified as having a probable mental disorder [1]. The majority of these children, when presenting to child mental health services, do not receive an evidence-based treatment. This is partly because most empirically tested treatments were developed to treat single disorders [2, 3], whereas the evidence indicates that the structure of mental health symptoms does not straightforwardly map onto traditional diagnostic categories and comorbidity of mental health problems is high [4, 5]. Indeed, most children referred for treatment show high rates of transdiagnostic co-morbidity–this is the rule, not the exception [6]. As a result, there is a significant research-practice gap. A solution to this research-practice gap is for clinical trials to focus on transdiagnostic interventions that target causal and maintaining factors underlying a range of clinical presentations. Transdiagnostic interventions are especially suitable for children, who show a great overlap in symptoms and a high level of transitory symptoms across developmental stages [7–9]. Transdiagnostic interventions also have good potential for implementation, as they allow clinicians to address diverse diagnoses and sub-threshold symptoms within a single treatment model, and simultaneously target multiple problem areas, so limiting training burden on clinicians [9–11]. Because of the ubiquity of emotion regulation (ER) difficulties across a wide range of psychopathologies, research has identified ER as a core transdiagnostic mechanism [12]. ER refers to implicit and explicit processes and strategies involved in regulating emotional states. Both adequate down-regulation of negative emotional states and up-regulation of positive states during childhood play a critical role in adaptive development and well-being [13]. ER difficulties have been associated with risk of psychopathology across both emotional and behavioural disorders [14–16]. Findings of a recent meta-analysis suggest that interv (...truncated)