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.

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 clinical- and 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 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.

Patient and Public Involvement in Youth Mental Health Research: Protocol for a Systematic Review of Practices and Impact.

Various health settings have advocated for involving patients and members of the public (PPI) in research as a means to increase quality and relevance of the produced knowledge. However, youth PPI has been an understudied area. This protocol paper describes a new project that aims to summarize what is known about PPI with young people in mental health research. In line with the Preferred Reporting Items for Systematic reviews and Meta-Analyses Statement guidelines we will identify and appraise suitable articles and extract and synthesize relevant information including at least two reviewers at each stage of the process. Results will be presented in two systematic reviews that will describe (a) how youth PPI has been conducted (Review1) and (b) what impact youth PPI had on the subsequent research and on stakeholders (Review2). To our knowledge, this is the first set of reviews that uses a critical appraisal tool, which is co-developed with children and young people. Findings from this project will provide valuable insights and set out the key steps to adopting adequate PPI methods when involving children and young people in mental health research.

An mHealth Intervention (ReZone) to Help Young People Self-Manage Overwhelming Feelings: Cluster-Randomized Controlled Trial.

BACKGROUND: Mental health difficulties in young people are increasing, and there is a need for evidence on the effectiveness of digital interventions to increase opportunities for supporting mental health in young people. Such studies are complicated due to issues of implementation and adoption, outcome measurement, and appropriate study designs. OBJECTIVE: The objective of this study was to examine the effectiveness of an mHealth intervention (ReZone) in reducing mental health difficulties in young people. METHODS: The cluster-randomized controlled trial enrolled 409 participants aged 10-15 years, and classes were allocated to ReZone or management as usual. Self-reported questionnaires were completed at baseline and 3-month follow-up. RESULTS: There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures. However, there were 3467 usage sessions, which corresponds to 16.9 times per student (total of 205 students) in classes allocated to ReZone. CONCLUSIONS: It is essential to publish studies that do not show significant differences, as these findings can still contribute to the literature, help in learning, and inform the direction of future work. The results reported in this paper could be due to a range of reasons, including whether ReZone has the scope to impact change or limitations related to the setting, context, and appropriateness of an RCT. The findings of this study suggest that ReZone was implemented and adopted. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.7019.

A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People.

BACKGROUND: Digital tools have the potential to support patient activation and shared decision making in the face of increasing levels of mental health problems in young people. There is a need for feasibility trials of digital interventions to determine the usage and acceptability of interventions. In addition, there is a need to determine the ability to recruit and retain research participants to plan rigorous effectiveness trials and, therefore, develop evidence-based recommendations for practice. OBJECTIVE: This study aimed to determine the feasibility of undertaking a cluster randomized controlled trial to test the effectiveness of a smartphone app, Power Up, co-designed with young people to support patient activation and shared decision making for mental health. METHODS: Overall, 270 young people were screened for participation and 52.5% (142/270) were recruited and completed baseline measures across 8 specialist child mental health services (n=62, mean age 14.66 (SD 1.99) year; 52% [32/62] female) and 2 mainstream secondary schools (n=80; mean age 16.88 [SD 0.68] years; 46% [37/80] female). Young people received Power Up in addition to management as usual or received management as usual only. Posttrial interviews were conducted with 11 young people from the intervention arms (specialist services n=6; schools n=5). RESULTS: Usage data showed that there were an estimated 50 (out of 64) users of Power Up in the intervention arms. Findings from the interviews indicated that young people found Power Up to be acceptable. Young people reported (1) their motivation for use of Power Up, (2) the impact of use, and (3) barriers to use. Out of the 142 recruited participants, 45.0% (64/142) completed follow-up measures, and the approaches to increase retention agreed by the steering group are discussed. CONCLUSIONS: The findings of this study indicate that the app is acceptable, and it is feasible to examine the effectiveness of Power Up in a prospective cluster randomized controlled trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT02552797; https://clinicaltrials.gov/ct2/show/NCT02552797 (Archived by WebCite at http://www.webcitation.org/6td6MINP0).

The Implementation of an mHealth Intervention (ReZone) for the Self-Management of Overwhelming Feelings Among Young People.

BACKGROUND: The association between mental health difficulties and academic attainment is well established. There is increasing research on mobile health (mHealth) interventions to provide support for the mental health and education of young people. However, nonadoption and inadequate implementation of mHealth interventions are prevalent barriers to such trials. OBJECTIVE: The aim of this study was to bridge this gap and examine the implementation of an mHealth intervention, ReZone, for young people in schools. METHODS: Preliminary data for 79 students collected as part of a larger trial were analyzed. We additionally conducted postimplementation consultations with teachers. RESULTS: ReZone was used 1043 times by 36 students in the intervention arm during the study period. Postimplementation teacher consultations provided data on implementation strategies, barriers, and facilitators. CONCLUSIONS: Implementation strategies, barriers, and facilitators for digital interventions need to be considered to limit nonadoption and inadequate implementation in larger trials. Important considerations involve tailoring the characteristics of the intervention to the requirements of the intended user group, the technology itself, and the organization in which it is implemented. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: 13425994; http://www.isrctn.com/ISRCTN13425994.

Correction: An App to Help Young People Self-Manage When Feeling Overwhelmed (ReZone): Protocol of a Cluster Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/resprot.7019.].

An App to Help Young People Self-Manage When Feeling Overwhelmed (ReZone): Protocol of a Cluster Randomized Controlled Trial.

BACKGROUND: The association between behavioral difficulties and academic attainment is well established. Recent policy advising schools on managing behavior has promoted the early identification of behavioral difficulties. There is also increasing research into mHealth interventions to provide support for emotional and behavioral difficulties for young people. OBJECTIVE: The primary aim of the proposed research is to examine the effectiveness of an mHealth intervention, ReZone, in reducing emotional and behavioral difficulties in young people. METHODS: The protocol is a cluster trial of 12 classes with N=120 students with classes randomized to ReZone or management as usual. Multilevel modeling will be used to compare ReZone versus management as usual accounting for classroom-level variation. RESULTS: Baseline data collection started in February 2017 and ended in April 2017. Follow-up data collection started in April 2017 and ended in June 2017. CONCLUSIONS: The proposed research will provide evidence as to whether ReZone is effective at helping young people to self-manage when feeling overwhelmed. TRIAL REGISTRATION: ISRCTN 13425994; http://www.isrctn.com/ISRCTN13425994 (Archived by WebCite at http://www.webcitation.org/6tePwwiHk).

Prevalence and Incidence of Hypoglycaemia in 532,542 People with Type 2 Diabetes on Oral Therapies and Insulin: A Systematic Review and Meta-Analysis of Population Based Studies.

OBJECTIVE: To collate and evaluate the current literature reporting the prevalence and incidence of hypoglycaemia in population based studies of type 2 diabetes. RESEARCH DESIGN AND METHODS: Medline, Embase and Cochrane were searched up to February 2014 to identify population based studies reporting the proportion of people with type 2 diabetes experiencing hypoglycaemia or rate of events experienced. Two reviewers independently screened studies for eligibility and extracted data for included studies. Random effects meta-analyses were carried out to calculate the prevalence and incidence of hypoglycaemia. RESULTS: 46 studies (n = 532,542) met the inclusion criteria. Prevalence of hypoglycaemia was 45% (95%CI 0.34,0.57) for mild/moderate and 6% (95%CI, 0.05,0.07) for severe. Incidence of hypoglycaemic episodes per person-year for mild/moderate and for severe was 19 (95%CI 0.00, 51.08) and 0.80 (95%CI 0.00,2.15), respectively. Hypoglycaemia was prevalent amongst those on insulin; for mild/moderate episodes the prevalence was 50% and incidence 23 events per person-year, and for severe episodes the prevalence was 21% and incidence 1 event per person-year. For treatment regimes that included a sulphonylurea, mild/moderate prevalence was 30% and incidence 2 events per person-year, and severe prevalence was 5% and incidence 0.01 events per person-year. A similar prevalence of 5% was found for treatment regimes that did not include sulphonylureas. CONCLUSIONS: Current evidence shows hypoglycaemia is considerably prevalent amongst people with type 2 diabetes, particularly for those on insulin, yet still fairly common for other treatment regimens. This highlights the subsequent need for educational interventions and individualisation of therapies to reduce the risk of hypoglycaemia.