Access to best-evidenced mental health support for care-experienced young people: Learnings from the implementation of cognitive therapy for PTSD.

OBJECTIVES: Rates of PTSD are up to 12 times higher in care-experienced young people (CEYP) compared to their peers. Trauma-focused CBTs (tf-CBT) are the best-evidenced treatment for youth with PTSD, yet, in practice, CEYP often struggle to access this treatment. We worked alongside services to understand barriers and facilitators of the implementation of cognitive therapy for PTSD (a type of tf-CBT) to CEYP. DESIGN: This was an active, open implementation trial. METHODS: We recruited 28 mental health teams across England, including general CAMHS, targeted CAMHS for CEYP and social care-based teams. From these teams, participants were 243 mental health professionals, from a wide variety of professional backgrounds. Following recruitment/intervention training, teams participated in rolling three monthly focus groups and individual interviews, to understand what helped and hindered implementation. Data were analysed using a framework analysis conducted using CFIR 2.0. RESULTS: Almost half of the teams were able to implement, but only approximately one quarter with CEYP, specifically. Universal barriers that were discussed by almost all teams particularly highlighted service structures and poor resourcing as major barriers to delivery to CEYP, as well as the complexities of the young person and their network. Unique factors that differentiated teams who did and did not implement included commissioning practices, the culture of the team, leadership engagement and style, and the development of supervision structures. CONCLUSIONS: Findings offer key considerations for mental health teams, service leads, commissioners and policy-makers to enhance delivery of best-evidenced mental health treatments like CT-PTSD, for CEYP.

Healthy Parent Carers: Acceptability and practicability of online delivery and learning through implementation by delivery partner organisations.

BACKGROUND: Parent carers of disabled children are at increased risk of physical and mental health problems. The Healthy Parent Carers (HPC) programme is a manualised peer-led group-based programme that aims to promote parent carer health and wellbeing. Previously, the programme had been delivered in person, with recruitment and delivery managed in a research context. This study explored implementation by two delivery partner organisations in the United Kingdom. Facilitator Training and Delivery Manuals were modified for online delivery using Zoom due to COVID-19. METHODS: The study methodology utilised the Replicating Effective Programs framework. A series of stakeholder workshops informed the development of the Implementation Logic Model and an Implementation Package. After delivering the programme, delivery partner organisations and facilitators participated in a workshop to discuss experiences of implementing the programme. A wider group of stakeholders, including commissioners, Parent Carer Forums and charity organisations representatives and researchers subsequently met to consider the sustainability and potential barriers to delivering the programme outside the research context. RESULTS: This study explored implementation by two delivery partner organisations in the United Kingdom that were able to recruit facilitators, who we trained, and they recruited participants and delivered the programme to parent carers in different localities using Zoom. The co-created Implementation Logic Model and Implementation Package were subsequently refined to enable the further roll-out of the programme with other delivery partner organisations. CONCLUSIONS: This study provides insight and understanding of how the HPC programme can be implemented sustainably outside of the research context. Further research will evaluate the effectiveness of the programme and refine the implementation processes. PATIENT AND PUBLIC CONTRIBUTION: Parent carers, delivery partner organisation staff and service commissioners were consulted on the design, delivery and reporting of the research.

Parent-carer experiences using a peer support network: a qualitative study.

INTRODUCTION: Parent-carers of children and young people (CYP) with mental health problems are at greater risk of poor outcomes, such as poor physical and mental health. Peer interventions for parent-carers of CYP with disabilities may improve parent-carer outcomes. This qualitative study investigates parent-carer experiences of using Parental Minds (PM), a multi-component peer support service for parent-carers of CYP with disabilities. METHODS: Twelve current service-users and four staff/volunteers at PM participated in one-to-one semi-structured interviews. All participants were white females, except for one service-user who was male. All interviews were recorded and transcribed verbatim. Thematic analysis of results was used to explore perceived benefits and disadvantages of PM and possible behaviour change mechanisms. RESULTS: Three themes and eight subthemes were identified. Participants identified that internal and external factors influence their self-concept. The identification of themselves as a priority, and empowerment by reassurance and affirmation lead to improved parent-carer self-efficacy and agency to better care for their CYP. Participants described the difficulty of speaking honestly with friends and family about what they experience because it is perceived as different to what "normal" parents experience. From participant accounts, PM enables the construction of a support network and links external services to help manage family circumstances rather than offer curative treatment/intervention. Proactive and immediate advice which is constantly and consistently available was valued by participants. Participants expressed the need for a flexible range of service components which provide holistic support that encompasses both health and social care. CONCLUSIONS: PM was perceived to be beneficial as a multi-component peer support service which increases parenting self-efficacy and empowerment, reduces isolation, improves access to services, and is tailored to individual needs. Parent-carers reported benefits in parenting and wellbeing practices. The development of a refined logic model will inform a future study of the effectiveness of PM on parent-carer outcomes.

Prioritising child health and maternity evidence-based interventions or service models: a stakeholder-driven process.

AIM: A UK programme, led by the National Institute for Health Research (NIHR) ( https://www.nihr.ac.uk ) and coordinated by Applied Research Collaborations (ARC), ( https://www.nihr.ac.uk/explore-nihr/support/collaborating-in-applied-health-research.htm ) aimed to identify and select evidence-based, implementation-ready service innovations for evaluation. The programme focused on seven areas of health provision. We report on a prioritisation process designed to identify and assess innovations in one of these areas: child and maternal health (CH&M). METHODS: We developed a three-stage, online, stakeholder driven process to 1) identify, 2) assess and prioritise and 3) select evidence-based interventions or service models, using crowdsourcing to identify projects and the APEASE criteria to assess and select projects. A brief evidence review was conducted for all initial suggestions to identify those with the largest evidence-base to take forward for ranking by stakeholders. Stakeholder workshops considered and ranked these suggestions using the APEASE criteria. We then conducted in-depth evidence reviews for the highest ranked suggestions. The Project Management Group and Advisory Board used these reviews and the APEASE criteria to select the final projects. RESULTS: We received 32 initial suggestions from a range of clinicians, practitioners and researchers. Fourteen of the most evidence-based suggestions were considered and ranked at four themed stakeholder workshops. Nine suggestions were ranked for further in-depth evidence review and a final four projects were selected for implementation evaluation using the APEASE criteria. These were: 1. Maternal Mental Health Services Multidisciplinary Teams 2. Early years tooth brushing programme 3. Trauma-focused CBT for young people in care and 4. Independent Domestic Violence Advisors in maternity settings. Feedback from participants suggested that having public representatives participating in all stakeholder meetings, rather than being consulted separately, focused discussions clearly on patient benefit rather than research aims. CONCLUSIONS: The stakeholder-driven process achieved its aim of identifying, prioritising and assessing and selecting, evidence-based projects for wider implementation and evaluation. The concurrent process could be adapted by other researchers or policy makers.

The Effectiveness of a Community-Based Mentoring Program for Children Aged 5-11 Years: Results from a Randomized Controlled Trial.

The study, a two-arm, randomized controlled, parallel group, superiority trial, aimed to evaluate the implementation and effectiveness of a 12-month one-to-one volunteer mentoring program designed to improve behavioral and emotional outcomes in children aged 5 to 11 years who have teacher- and parent/carer-reported behavioral difficulties. Participants were 246 children (123 intervention, 123 control; mean age 8.4 years; 87% boys) in five sites in London, UK, scoring in the "abnormal" range on the teacher-rated Strengths and Difficulties Questionnaire (SDQ) Total Difficulties measure and in the "borderline" or abnormal range on the parent-rated SDQ Total Difficulties measure. Randomization on a 1:1 ratio took place using a computer-generated sequence and stratifying by site. Data collectors and statisticians were blind to participant allocation status. Outcome measures focused on parent- and teacher-rated child behavior and emotions, and child-rated self-perception and hope. Intention-to-treat analysis on all 246 randomized participants (using imputed data where necessary) showed that at post-intervention (16 months after randomization), there were no statistically significant effects on the primary outcome-parent-rated SDQ Total Difficulties (adjusted standardized mean difference = - 0.12; 95% CI: -0.38 to 0.13; p = 0.33)-or any secondary outcomes. Results from complier average causal effect (CACE) analysis using the primary outcome indicated the intervention was not effective for children who received the recommended duration of mentoring. Exploratory analyses found no sub-group effects on the primary outcome. The article concludes that the mentoring program had no effect on children's behavior or emotional well-being, and that program content needs revising to satisfactorily address key risk and protective factors.

The Effectiveness of the KiVa Bullying Prevention Program in Wales, UK: Results from a Pragmatic Cluster Randomized Controlled Trial.

The study evaluated the implementation fidelity and effectiveness of KiVa, an evidence-based program that aims to prevent and address bullying in schools, with a particular emphasis on changing the role of bystanders. The study was a two-arm waitlist control cluster randomized controlled trial in which 22 primary schools (clusters) (N = 3214 students aged 7-11) were allocated using a 1:1 ratio to intervention (KiVa; 11 clusters, n = 1588 students) and a waitlist control (usual school provision; 11 clusters, n = 1892 children)). The trial statistician (but not schools or researchers) remained blind to allocation status. The outcomes were as follows: student-reported victimization (primary outcome) and bullying perpetration; teacher-reported child behavior and emotional well-being; and school absenteeism (administrative records). Implementation fidelity was measured using teacher-completed online records (for class lessons) and independent researcher observations (for school-wide elements). Outcome analyses involved 11 intervention schools (n = 1578 children) and 10 control schools (n = 1636 children). There was no statistically significant effect on the primary outcome of child-reported victimization (adjusted intervention/control OR 0.76; 95% CI 0.55 to 1.06; p = 0.11) or on the secondary outcomes. The impact on victimization was not moderated by child gender, age, or victimization status at baseline. Lesson adherence was good but exposure (lesson length) was lower than the recommended amount, and there was considerable variability in the implementation of whole school elements. The trial found insufficient evidence to conclude that KiVa had an effect on the primary outcome. A larger trial of KiVa in the UK is warranted, however, with attention to issues regarding implementation fidelity. Trial registration: Current Controlled Trials ISRCTN23999021 Date 10-6-13.

Healthy Parent Carers programme: development and feasibility of a novel group-based health-promotion intervention.

BACKGROUND: Parent carers of disabled children report poor physical health and mental wellbeing. They experience high levels of stress and barriers to engagement in health-related behaviours and with 'standard' preventive programmes (e.g. weight loss programmes). Interventions promoting strategies to improve health and wellbeing of parent carers are needed, tailored to their specific needs and circumstances. METHODS: We developed a group-based health promotion intervention for parent carers by following six steps of the established Intervention Mapping approach. Parent carers co-created the intervention programme and were involved in all stages of the development and testing. We conducted a study of the intervention with a group of parent carers to examine the feasibility and acceptability. Standardised questionnaires were used to assess health and wellbeing pre and post-intervention and at 2 month follow up. Participants provided feedback after each session and took part in a focus group after the end of the programme. RESULTS: The group-based Healthy Parent Carers programme was developed to improve health and wellbeing through engagement with eight achievable behaviours (CLANGERS - Connect, Learn, be Active, take Notice, Give, Eat well, Relax, Sleep), and by promoting empowerment and resilience. The manualised intervention was delivered by two peer facilitators to a group of seven parent carers. Feedback from participants and facilitators was strongly positive. The study was not powered or designed to test effectiveness but changes in measures of participants' wellbeing and depression were in a positive direction both at the end of the intervention and 2 months later which suggest that there may be a potential to achieve benefit. CONCLUSIONS: The Healthy Parent Carers programme appears feasible and acceptable. It was valued by, and was perceived to have benefited participants. The results will underpin future refinement of the intervention and plans for evaluation.

Effectiveness and micro-costing of the KiVa school-based bullying prevention programme in Wales: study protocol for a pragmatic definitive parallel group cluster randomised controlled trial.

BACKGROUND: Bullying refers to verbal, physical or psychological aggression repeated over time that is intended to cause harm or distress to the victims who are unable to defend themselves. It is a key public health priority owing to its widespread prevalence in schools and harmful short- and long-term effects on victims' well-being. There is a need to strengthen the evidence base by testing innovative approaches to preventing bullying. KiVa is a school-based bullying prevention programme with universal and indicated elements and an emphasis on changing bystander behaviour. It achieved promising results in a large trial in Finland, and now requires testing in other countries. This paper describes the protocol for a cluster randomised controlled trial (RCT) of KiVa in Wales. METHODS/DESIGN: The study uses a two-arm waitlist control pragmatic definitive parallel group cluster RCT design with an embedded process evaluation and calculation of unit cost. Participating schools will be randomised a using a 1:1 ratio to KiVa plus usual provision (intervention group) or usual provision only (control group). The trial has one primary outcome, child self-reported victimisation from bullying, dichotomised as 'victimised' (bullied at least twice a month in the last couple of months) versus 'not victimised'. Secondary outcomes are: bullying perpetration; aspects of child social and emotional well-being (including emotional problems, conduct, peer relations, prosocial behaviour); and school attendance. Follow-up is at 12 months post-baseline. Implementation fidelity is measured through teacher-completed lesson records and independent school-wide observation. A micro-costing analysis will determine the costs of implementing KiVa, including recurrent and non-recurrent unit costs. Factors related to the scalability of the programme will be examined in interviews with head teachers and focus groups with key stakeholders in the implementation of school-based bullying interventions. DISCUSSION: The results from this trial will provide evidence on whether the KiVa programme is transportable from Finland to Wales in terms of effectiveness and implementation. It will provide information about the costs of delivery and generate insights into factors related to the scalability of the programme. TRIAL REGISTRATION: Current Controlled Trials ISRCTN23999021 Date 10-6-13.

A comparison of the effectiveness of cognitive behavioural interventions based on delivery features for elevated symptoms of depression in adolescents: A systematic review.

Background: Depression is a public health problem and common amongst adolescents. Cognitive behavioural therapy (CBT) is widely used to treat adolescent depression but existing research does not provide clear conclusions regarding the relative effectiveness of different delivery modalities. Objectives: The primary aim is to estimate the relative efficacy of different modes of CBT delivery compared with each other and control conditions for reducing depressive symptoms in adolescents. The secondary aim is to compare the different modes of delivery with regard to intervention completion/attrition (a proxy for intervention acceptability). Search Methods: The Cochrane Depression, Anxiety and Neurosis Clinical Trials Register was searched in April 2020. MEDLINE, PsycInfo, EMBASE, four other electronic databases, the CENTRAL trial registry, Google Scholar and Google were searched in November 2020, together with reference checking, citation searching and hand-searching of two databases. Selection Criteria: Randomised controlled trials (RCTs) of CBT interventions (irrespective of delivery mode) to reduce symptoms of depression in young people aged 10-19 years with clinically relevant symptoms or diagnosis of depression were included. Data Collection and Analysis: Screening and data extraction were completed by two authors independently, with discrepancies addressed by a third author. CBT interventions were categorised as follows: group CBT, individual CBT, remote CBT, guided self-help, and unguided self-help. Effect on depressive symptom score was estimated across validated self-report measures using Hedges' g standardised mean difference. Acceptability was estimated based on loss to follow-up as an odds ratio. Treatment rankings were developed using the surface under the cumulative ranking curve (SUCRA). Pairwise meta-analyses were conducted using random effects models where there were two or more head-to-head trials. Network analyses were conducted using random effects models. Main Results: Sixty-eight studies were included in the review. The mean age of participants ranged from 10 to 19.5 years, and on average 60% of participants were female. The majority of studies were conducted in schools (28) or universities (6); other settings included primary care, clinical settings and the home. The number of CBT sessions ranged from 1 to 16, the frequency of delivery from once every 2 weeks to twice a week and the duration of each session from 20 min to 2 h. The risk of bias was low across all domains for 23 studies, 24 studies had some concerns and the remaining 21 were assessed to be at high risk of bias. Sixty-two RCTs (representing 6435 participants) were included in the pairwise and network meta-analyses for post-intervention depressive symptom score at post-intervention. All pre-specified treatment and control categories were represented by at least one RCT. Although most CBT approaches, except remote CBT, demonstrated superiority over no intervention, no approaches performed clearly better than or equivalent to another. The highest and lowest ranking interventions were guided self-help (SUCRA 83%) and unguided self-help (SUCRA 51%), respectively (very low certainty in treatment ranking). Nineteen RCTs (3260 participants) were included in the pairwise and network meta-analyses for 6 to 12 month follow-up depressive symptom score. Neither guided self-help nor remote CBT were evaluated in the RCTs for this time point. Effects were generally attenuated for 6- to 12-month outcomes compared to posttest. No interventions demonstrated superiority to no intervention, although unguided self-help and group CBT both demonstrated superiority compared to TAU. No CBT approach demonstrated clear superiority over another. The highest and lowest ranking approaches were unguided self-help and individual CBT, respectively. Sixty-two RCTs (7347 participants) were included in the pairwise and network meta-analyses for intervention acceptability. All pre-specified treatment and control categories were represented by at least one RCT. Although point estimates tended to favour no intervention, no active treatments were clearly inferior. No CBT approach demonstrated clear superiority over another. The highest and lowest ranking active interventions were individual CBT and group CBT respectively. Pairwise meta-analytic findings were similar to those of the network meta-analysis for all analyses. There may be age-based subgroup effects on post-intervention depressive symptoms. Using the no intervention control group as the reference, the magnitudes of effects appear to be larger for the oldest age categories compared to the other subgroups for each given comparison. However, they were generally less precise and formal testing only indicated a significant difference for group CBT. Findings were robust to pre-specified sensitivity analyses separating out the type of placebo and excluding cluster-RCTs, as well as an additional analysis excluding studies where we had imputed standard deviations. Authors' Conclusions: At posttreatment, all active treatments (group CBT, individual CBT, guided self-help, and unguided self-help) except for remote CBT were more effective than no treatment. Guided self-help was the most highly ranked intervention but only evaluated in trials with the oldest adolescents (16-19 years). Moreover, the studies of guided self-help vary in the type and amount of therapist support provided and longer-term results are needed to determine whether effects persist. The magnitude of effects was generally attenuated for 6- to 12-month outcomes. Although unguided self-help was the lowest-ranked active intervention at post-intervention, it was the highest ranked at follow-up. This suggests the need for further research into whether interventions with self-directed elements enable young people to maintain effects by continuing or revisiting the intervention independently, and whether therapist support would improve long-term outcomes. There was no clear evidence that any active treatments were more acceptable to participants than any others. The relative effectiveness of intervention delivery modes must be taken into account in the context of the needs and preferences of individual young people, particularly as the differences between effect sizes were relatively small. Further research into the type and amount of therapist support that is most acceptable to young people and most cost-effective would be particularly useful.

Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children.

BACKGROUND: Parent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who co-developed the Healthy Parent Carers programme with researchers. This study aimed to test the feasibility of programme delivery in community settings, and the feasibility and acceptability of a randomised controlled trial design. METHODS: Participants were individually randomised with concealed allocation to a structured group programme and access to online resources (intervention), or access to the online resources only (control). Measures of wellbeing and secondary and economic outcomes were collected before randomisation, immediately post-intervention, and 6 months post-intervention. Descriptive statistics on recruitment and attrition, demographics, attendance, and fidelity of intervention delivery were analysed with feedback on the acceptability of the trial design. RESULTS: One hundred and ninety-three parent carers expressed an interest in taking part. Ninety-two participants recruited from across six sites were randomised (47 intervention, 45 control). Lead and assistant facilitators were trained and delivered the group sessions. Sixteen (34%) participants in the intervention arm did not attend any sessions, and attendance varied across sites and sessions. One participant withdrew post-randomisation, and 83 (90%) participants completed outcome measures at the six-month follow-up. CONCLUSIONS: The study demonstrated that it was feasible to deliver the programme in community settings. The number of parent carers who expressed interest signifies the need for such a programme and the feasibility of recruiting to a definitive trial. Loss to follow-up was low. Further research is needed to explore ways to reduce barriers to participation in person and assess the feasibility and acceptability of programme content and delivery for more ethnically diverse groups, and potentially using interpreters. Given the Covid-19 pandemic and delivery format feedback, there is also a need to investigate remote or blended delivery strategies. Although the results indicate that a definitive trial is feasible, programme impact would be strengthened through exploration of these uncertainties. TRIAL REGISTRATION: ISRCTN, ISRCTN15144652 , registered on 25 October 2018, ClinicalTrials.gov , NCT03705221 , registered on 15 October 2018.

Healthy Parent Carers programme: mixed methods process evaluation and refinement of a health promotion intervention.

OBJECTIVES: Parent carers of children with special educational needs or disability are at risk of poorer mental and physical health. In response to these needs, we codeveloped the 'Healthy Parent Carers' (HPC) programme. This study examined the views and experiences of participants in the HPC feasibility trial to inform programme refinement. INTERVENTION, SETTING AND PARTICIPANTS: HPC is a peer-led group-based intervention (supported by online materials) for primary carers of disabled children, encouraging behaviours linked with health and well-being. It was delivered by two lead and six assistant peer facilitators in six community sites (one lead and one assistant per group) in South West England over six or 12 sessions. Control participants had online materials only. The trial involved 47 intervention and 45 control parent carers (97% female and 97% white) and eight facilitators (one male). DESIGN: A preplanned mixed methods process evaluation using questionnaires and checklists (during and after the intervention), qualitative interviews with participants after intervention (n=18) and a focus group with facilitators after trial. RESULTS: HPC was highly acceptable to participants and facilitators and experiences were very positive. Participants reported that the programme increased awareness of what parent carers could and could not change and their self-efficacy to engage in health-promoting behaviours. The intended mechanisms of action (social identification and peer support) matched participants' expectations and experiences. Control participants found the online-only programme flexible but isolating, as there were no opportunities to share ideas and problem solve with peers, the key function of the programme. Areas for improvement were identified for programme content, facilitator training and delivery. CONCLUSION: HPC was acceptable, well received and offers considerable potential to improve the health of parent carers. Under the pandemic, the challenge going forward is how best to maintain reach and fidelity to function while delivering a more virtual programme. TRIAL REGISTRATION NUMBER: ISRCTN151144652.

PROTOCOL: A comparison of the effectiveness of cognitive behavioural interventions based on delivery features for elevated symptoms of depression in adolescents.

This is the protocol for a Campbell review. The primary aim is to estimate the relative efficacy of different modes of CBT delivery compared with control conditions for reducing depressive symptoms in adolescents. The secondary aim is to compare the different modes of delivery with regards to intervention completion/attrition (used as a proxy for intervention acceptability). The review will provide relative effect estimates and ranking probabilities for each outcome based on intervention delivery.

Public involvement in health research: what does 'good' look like in practice?

PLAIN ENGLISH SUMMARY: Background Patient and public involvement means researchers working with members of the public, patients or carers to jointly plan and carry out research.Aim This article is written by members of three involvement groups, and the university employees that they work with. We wanted to jointly reflect on what enables our collaborative work, and what the challenges are for everyone involved.What we did and how we did it We wanted to establish what the literature defines as 'good' public involvement and compare this with processes and practices in our involvement groups. We therefore carried out a literature review and each group met separately to discuss what characterises good involvement, and what the challenges are. From these discussions we developed a set of descriptions about each group. We compared the literature review findings with what came out of the discussions within the involvement groups.Findings Some of the involvement principles from the literature were similar to the priorities of the involvement groups. In addition, the groups identified characteristics of 'good' involvement practice that were not reported in the literature: passion and enthusiasm, informal and welcoming meeting spaces, and opportunities to share lived experiences. In this article we present examples of how principles for good involvement are practiced in these groups, and difficulties we have experienced. ABSTRACT: Background Patient and public involvement is important for producing relevant and accessible health research. Evidence of impact from involvement is growing, but there is also a need for research on how to create conditions for meaningful collaborations between researchers and public advisers.Objective We report on a co-produced self-reflective evaluation of involvement practices in three UK research programmes.Methods A structured review identified research-based principles for 'good' public involvement in research. In parallel, members of three involvement groups co-developed statements on how the groups work, and enablers and challenges to collaborative research. The author team analysed these statements using the findings from the review.Results We identified 11 international articles reporting research-based principles for involvement published between 2013 and 2017. We identified five 'values' and seven 'practice principles' for 'good' involvement. There was convergence between these principles and the priorities of the involvement groups. But the groups also identified additional good involvement practice that were not reported by the literature: passion, enthusiasm, informal and welcoming meeting spaces, and opportunities to share lived experiences. We present examples of how principles for good involvement are practiced in these groups, and highlight principles that have been challenging to implement.Conclusions Ongoing appraisal of public involvement is crucial. We present a process for self-evaluation, illuminate what 'good' means to researchers and public advisers involved in research, and identify areas for improvement. We conclude that provision of resources that enable support to public advisers in turn enable universities and research teams to implement other principles of good involvement.

Healthy Parent Carers peer-led group-based health promotion intervention for parent carers of disabled children: protocol for a feasibility study using a parallel group randomised controlled trial design.

BACKGROUND: Parent carers of disabled children are at increased risk of mental and physical health problems. They often experience challenges to maintaining good health which have implications for their well-being and their ability to care for their children. In response to these needs, researchers and parent carers developed the Healthy Parent Carers (HPC) programme. It is a peer-led, group-based intervention that promotes behaviours associated with health and well-being. The aims of this trial are to assess the acceptability of the HPC programme and the feasibility of its delivery in the community and to assess the feasibility and acceptability of the design of the definitive trial to evaluate the programme's effectiveness and cost-effectiveness. METHODS: We will establish six research sites and train facilitators to deliver the manualised intervention. Parent carers of children with special educational needs and disabilities will be individually randomised, stratified by group delivery site, to either take part in a group programme and online resources (intervention) or to receive access to the online resources only (control). Measures of mental health; well-being; health-related quality of life; health behaviours; patient activation; protective factors such as resilience, social connections, and practical support; and use of health care, social care, and wider societal resources will be collected before randomisation (baseline), immediately post-intervention, and 6 months later. Recruitment of participants, adherence to the programme, and the dose received will be assessed. Group sessions will be audio-recorded to evaluate the fidelity of delivery and participant engagement. Participants' and facilitators' feedback on the programme content and delivery, their experience, and the acceptability of the outcome measures and trial design will be collected through feedback forms, interviews, and focus groups. DISCUSSION: This trial will assess whether the programme delivery and evaluative trial design are feasible, to inform whether to progress to a definitive randomised controlled trial to test the effectiveness and cost-effectiveness of the Healthy Parent Carers programme. TRIAL REGISTRATION: ISRCTN, ISRCTN151144652, registered on 25 October 2018; ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

The effectiveness of Chance UK's mentoring programme in improving behavioural and emotional outcomes in primary school children with behavioural difficulties: study protocol for a randomised controlled trial.

BACKGROUND: There is a need to build the evidence base of early interventions to promote children's health and development in the UK. Chance UK is a voluntary sector organisation based in London that delivers a 12-month mentoring programme for primary school children identified by teachers and parents as having behavioural and emotional difficulties. The aim of the study is to determine the effectiveness of the programme in terms of children's behaviour and emotional well-being; this is the primary outcome of the trial. METHODS/DESIGN: A randomised controlled trial will be conducted in which participants are randomly allocated on a dynamic basis to one of two possible arms: the intervention arm (n = 123) will be offered the mentoring programme, and the control arm (n = 123) will be offered services as usual. Outcome data will be collected at three points: pre-intervention (baseline), mid-way through the mentoring year (c.9 months after randomisation) and post- mentoring programme (c.16 months after randomisation). DISCUSSION: This study will further enhance the evidence for early intervention mentoring programmes for child behaviour and emotional well-being in the UK. TRIAL REGISTRATION: Current Controlled Trials ISRCTN47154925 . Retrospectively registered 9 September 2014.

The effectiveness of the Inspiring Futures parenting programme in improving behavioural and emotional outcomes in primary school children with behavioural or emotional difficulties: study protocol for a randomised controlled trial.

BACKGROUND: There is a need to build the evidence base of early interventions promoting children's health and development in the UK. Malachi Specialist Family Support Services ('Malachi') is a voluntary sector organisation based in the UK that delivers a therapeutic parenting group programme called Inspiring Futures to parents of children identified as having behavioural and emotional difficulties. The programme comprises two parts, delivered sequentially: (1) a group-based programme for all parents for 10-12 weeks, and (2) one-to-one sessions with selected parents from the group-based element for up to 12 weeks. METHODS/DESIGN: A randomised controlled trial will be conducted to evaluate Malachi's Inspiring Futures parenting programme. Participants will be allocated to one of two possible arms, with follow-up measures at 16 weeks (post-parent group programme) and at 32 weeks (post-one-to-one sessions with selected parents). The sample size is 248 participants with a randomisation allocation ratio of 1:1. The intervention arm will be offered the Inspiring Futures programme. The control group will receive services as usual. The aim is to determine the effectiveness of the Inspiring Futures programme on the primary outcome of behavioural and emotional difficulties of primary school children identified as having behavioural or emotional difficulties. DISCUSSION: This study will further enhance the evidence for early intervention parenting programmes for child behavioural and emotional problems in the UK. TRIAL REGISTRATION: Current Controlled Trials ISRCTN32083735 . Retrospectively registered 28 October 2014.

An observational study of social exclusion under varied conditions: gender and developmental differences.

To investigate social exclusion, 146 dyads of close friends (N = 292, ages 10, 12, and 14) were observed as they played a board game with a same-gender confederate actor, trained to be a difficult play partner. Verbalizations and gestures were coded for verbal and nonverbal social exclusion, verbal aggression, and verbal assertion. The results indicated few developmental differences. For verbal responses in the presence of the actor, boys were more socially exclusive and verbally aggressive than were girls. Girls engaged in more nonverbal social exclusion in the presence of the actor than did boys. Girls' socially exclusive behaviors were unrelated to other negative behaviors and more strongly related between friends in the actor's absence.