The UK stand together trial: protocol for a multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of KiVa to reduce bullying in primary schools.

BACKGROUND: Reducing bullying is a public health priority. KiVa, a school-based anti-bullying programme, is effective in reducing bullying in Finland and requires rigorous testing in other countries, including the UK. This trial aims to test the effectiveness and cost-effectiveness of KiVa in reducing child reported bullying in UK schools compared to usual practice. The trial is currently on-going. Recruitment commenced in October 2019, however due to COVID-19 pandemic and resulting school closures was re-started in October 2020. METHODS: Design: Two-arm pragmatic multicentre cluster randomised controlled trial with an embedded process and cost-effectiveness evaluation. PARTICIPANTS: 116 primary schools from four areas; North Wales, West Midlands, South East and South West England. Outcomes will be assessed at student level (ages 7-11 years; n = approximately 13,000 students). INTERVENTION: KiVa is a whole school programme with universal actions that places a strong emphasis on changing bystander behaviour alongside indicated actions that provide consistent strategies for dealing with incidents of bullying. KiVa will be implemented over one academic year. COMPARATOR: Usual practice. PRIMARY OUTCOME: Student-level bullying-victimisation assessed through self-report using the extensively used and validated Olweus Bully/Victim questionnaire at baseline and 12-month follow-up. SECONDARY OUTCOMES: student-level bullying-perpetration; student mental health and emotional well-being; student level of, and roles in, bullying; school related well-being; school attendance and academic attainment; and teachers' self-efficacy in dealing with bullying, mental well-being, and burnout. SAMPLE SIZE: 116 schools (58 per arm) with an assumed ICC of 0.02 will provide 90% power to identify a relative reduction of 22% with a 5% significance level. RANDOMISATION: recruited schools will be randomised on 1:1 basis stratified by Key-Stage 2 size and free school meal status. Process evaluation: assess implementation fidelity, identify influences on KiVa implementation, and examine intervention mechanisms. Economic evaluation: Self-reported victimisation, Child Health Utility 9D, Client Service Receipt Inventory, frequency of services used, and intervention costs. The health economic analysis will be conducted from a schools and societal perspective. DISCUSSION: This two-arm pragmatic multicentre cluster randomised controlled trial will evaluate the KiVa anti-bullying intervention to generate evidence of the effectiveness, cost-effectiveness and scalability of the programme in the UK. Our integrated process evaluation will assess implementation fidelity, identify influences on KiVa implementation across England and Wales and examine intervention mechanisms. The integrated health economic analysis will be conducted from a schools and societal perspective. Our trial will also provide evidence regarding the programme impact on inequalities by testing whether KiVa is effective across the socio-economic gradient. TRIAL REGISTRATION: Trials ISRCTN 12300853 Date assigned 11/02/2020.

Social Interface Model: Theorizing Ecological Post-Delivery Processes for Intervention Effects.

Successful prevention programs depend on a complex interplay among aspects of the intervention, the participant, the specific intervention setting, and the broader set of contexts with which a participant interacts. There is a need to theorize what happens as participants bring intervention ideas and behaviors into other life-contexts, and theory has not yet specified how social interactions about interventions may influence outcomes. To address this gap, we use an ecological perspective to develop the social interface model. This paper presents the key components of the model and its potential to aid the design and implementation of prevention interventions. The model is predicated on the idea that intervention message effectiveness depends not only on message aspects but also on the participants' adoption and adaptation of the message vis-à-vis their social ecology. The model depicts processes by which intervention messages are received and enacted by participants through social processes occurring within and between relevant microsystems. Mesosystem interfaces (negligible interface, transference, co-dependence, and interdependence) can facilitate or detract from intervention effects. The social interface model advances prevention science by theorizing that practitioners can create better quality interventions by planning for what occurs after interventions are delivered.

Implementation of a Cooking Bus intervention to support cooking in schools in Wales, UK.

PURPOSE: The teaching of cooking is an important aspect of school-based efforts to promote healthy diets among children, and is frequently done by external agencies. Within a limited evidence base relating to cooking interventions in schools, there are important questions about how interventions are integrated within school settings. The purpose of this paper is to examine how a mobile classroom (Cooking Bus) sought to strengthen connections between schools and cooking, and drawing on the concept of the sociotechnical network, theorise the interactions between the Bus and school contexts. DESIGN/METHODOLOGY/APPROACH: Methods comprised a postal questionnaire to 76 schools which had received a Bus visit, and case studies of the Bus' work in five schools, including a range of school sizes and urban/rural locations. Case studies comprised observation of Cooking Bus sessions, and interviews with school staff. FINDINGS: The Cooking Bus forged connections with schools through aligning intervention and schools' goals, focussing on pupils' cooking skills, training teachers and contributing to schools' existing cooking-related activities. The Bus expanded its sociotechnical network through post-visit integration of cooking activities within schools, particularly teachers' use of intervention cooking kits. RESEARCH LIMITATIONS/IMPLICATIONS: The paper highlights the need for research on the long-term impacts of school cooking interventions, and better understanding of the interaction between interventions and school contexts. ORIGINALITY/VALUE: This paper adds to the limited evidence base on school-based cooking interventions by theorising how cooking interventions relate to school settings, and how they may achieve integration.

Preventing substance misuse: study protocol for a randomised controlled trial of the Strengthening Families Programme 10-14 UK (SFP 10-14 UK).

BACKGROUND: Prevention of alcohol, drug and tobacco misuse by young people is a key public health priority. There is a need to develop the evidence base through rigorous evaluations of innovative approaches to substance misuse prevention. The Strengthening Families Programme 10-14 is a universal family-based alcohol, drugs and tobacco prevention programme, which has achieved promising results in US trials, and which now requires cross-cultural assessment. This paper therefore describes the protocol for a randomised controlled trial of the UK version of the Strengthening Families Programme 10-14 (SFP 10-14 UK). METHODS/DESIGN: The trial comprises a pragmatic cluster randomised controlled effectiveness trial with families as the unit of randomisation, with embedded process and economic evaluations. Participating families will be randomised to one of two treatment groups - usual care with full access to existing services (control group), or usual care plus SFP 10-14 UK (intervention group). The trial has two primary outcomes - the number of occasions that young people report having drunk alcohol in the last 30 days, and drunkenness during the last 30 days, both dichotomised as 'never' and '1-2 times or more'. The main follow-up is at 2 years past baseline, and short-term and intermediate outcomes are also measured at 9 and 15 months. DISCUSSION: The results from this trial will provide evidence on the effectiveness and cost-effectiveness of an innovative universal family-based substance misuse prevention programme in a UK context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN63550893.

Renegotiating inter-professional boundaries in maternity care: implementing a clinical pathway for normal labour.

This article presents findings from a study of a clinical pathway for normal labour (Normal Labour Pathway) implemented in Wales, UK. The study was conducted between 2004 and 2006. The pathway aimed to support normal childbirth and reduce unnecessary childbirth interventions by promoting midwife-led care. This article focuses on how the pathway influenced the inter-professional relationships and boundaries between midwives and doctors. Data are drawn from semi-participant observation, focus groups and semi-structured interviews with 41 midwives, and semi-structured interviews with five midwifery managers and six doctors, working in two research sites. Whereas some studies have shown how clinical pathways may act as 'boundary objects', dissolving professional boundaries, promoting interdisciplinary care and de-differentiating professional identities, the 'normal labour pathway' was employed by midwives as an object of demarcation, which legitimised a midwifery model of care, clarified professional boundaries and accentuated differences in professional identities and approaches to childbirth. The pathway represented key characteristics of a professional project: achieving occupational autonomy and closure. Stricter delineation of the boundary between midwifery and obstetric work increased the confidence and professional visibility of midwives but left doctors feeling excluded and undervalued, and paradoxically reduced the scope of midwifery practice through redefining what counted as normal.

Improving the inclusion of an under-served group in trials: development and implementation of the INCLUDE Impaired Capacity to Consent Framework.

BACKGROUND: For the potential benefits of trials to reach all that they should, trials must be designed to ensure that those taking part reflect the population who will receive the intervention. However, adults with impaired capacity to consent are frequently excluded from trials - partly because researchers are unfamiliar with the legal and ethical frameworks and lack the necessary methodological expertise. Researchers identified a need for guidance on designing more inclusive trials. Building on the NIHR INCLUDE initiative, we developed the INCLUDE Impaired Capacity to Consent Framework to help researchers design inclusive trials. METHODS: The framework was developed over five phases: (1) establishing the scope and content of the framework and adapting the INCLUDE Ethnicity Framework for this population; (2) scoping the relevance of the framework to different populations and piloting in a range of trials; (3) consulting people living with impairing conditions and carers to explore their views about the framework and identify missing content areas; (4) refining the framework; and (5) the development of an implementation toolkit of resources to support researchers using the framework. RESULTS: The framework has two parts: a set of four key questions to help researchers identify who should be included in their trial, and a series of worksheets covering intervention design, recruitment and consent processes, data collection and analysis, and public involvement and dissemination. It is supported by a summary of the ethical and legal frameworks and a website of resources on capacity and consent. Implementation resources include infographics and animations, a library of completed frameworks, and facilitated workshops for researchers. The framework and toolkit were launched at a webinar (November 2022), with polling demonstrating an increase in attendees' awareness about research involving adults lacking capacity. A post-webinar survey found that stakeholders viewed the framework and toolkit as valuable tools to facilitate greater inclusion of this under-served population in trials. The framework is available online: https://www.capacityconsentresearch.com/include-impaired-capacity-to-consent-framework.html . CONCLUSIONS: The INCLUDE Impaired Capacity to Consent Framework and implementation toolkit can support researchers to design more inclusive trials and other types of research studies. Further engagement, including with funders who are key to ensuring uptake, and evaluation is needed.

Watch Me Play!: protocol for a feasibility study of a remotely delivered intervention to promote mental health resilience for children (ages 0-8) across UK early years and children's services.

BACKGROUND: Half of mental health problems are established by the age of 14 years and 75% by 24 years. Early intervention and prevention of mental ill health are therefore vitally important. However, increased demand over recent years has meant that access to child mental health services is often restricted to those in severest need. Watch Me Play! (WMP) is an early intervention designed to support caregiver attunement and attention to the child to promote social-emotional well-being and thereby mental health resilience. Originally developed in the context of a local authority mental health service for children in care, it is now also delivered online as a low intensity, scalable, preventative intervention. Although WMP shows promise and is already used in some services, we do not yet know whether it is effective. METHODS: A non-randomised single group feasibility study with embedded process evaluation. We propose to recruit up to 40 parents/carers of children aged 0-8 years who have been referred to early years and children's services in the UK. WMP involves a parent watching the child play and talking to their child about their play (or for babies, observing and following signals) for up to 20 min per session. Some sessions are facilitated by a trained practitioner who provides prompts where necessary, gives feedback, and discusses the child's play with the caregiver. Services will offer five facilitated sessions, and parents will be asked to do at least 10 additional sessions on their own with their child in a 5-week period. Feasibility outcomes examined are as follows: (i) recruitment, (ii) retention, (iii) adherence, (iv) fidelity of delivery, (v) barriers and facilitators of participation, (vi) intervention acceptability, (vii) description of usual care, and (viii) data collection procedures. Intervention mechanisms will be examined through qualitative interview data. Economic evaluation will be conducted estimating cost of the intervention and cost of service use for child and parents/carers quality-adjusted life years. DISCUSSION: This study will address feasibility questions associated with progression to a future randomised trial of WMP. TRIAL REGISTRATION: ISRCTN13644899 . Registered on 14th April 2023.

Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10-17-year-olds presenting at police custody: a randomised controlled trial.

BACKGROUND: Within England, children and young people (CYP) who come into police custody are referred to Liaison and Diversion (L&D) teams. L&D teams have responsibility for liaising with healthcare and other support services while working to divert CYP away from the criminal justice system but have traditionally not provided targeted psychological interventions to CYP. Considering evidence that Solution Focused Brief Therapy (SFBT) leads to a reduction in internalising and externalising behaviour problems in CYP, the aim of this randomised controlled trial (RCT) was to determine whether there is a difference between services as usual (SAU) plus SFBT offered by trained therapists working within a L&D team, and SAU alone, in reducing offending behaviours in 10-17-year-olds presenting at police custody. METHODS: Design: two-arm individually RCT with internal pilot and process evaluation. PARTICIPANTS: N = approximately 448 CYP aged 10-17 years presenting at one of three police custody suites in the area served by Lancashire and South Cumbria NHS Foundation Trust (LSCFT) who are referred to the L&D team. Participants will be recruited and allocated to intervention:control on a 1:1 basis. Interviews will be performed with 30-40 CYP in the intervention arm, 15 CYP in the control arm, up to 20 parents/guardians across both arms, up to 15 practitioners, and up to 10 site staff responsible for screening CYP for the trial. Intervention and control: Those allocated to the intervention will be offered SAU plus SFBT, and control participants will receive SAU only. PRIMARY OUTCOME: CYP frequency of offending behaviours assessed through the Self-Report Delinquency Measure (SRDM) at 12 months post-randomisation. SECONDARY OUTCOMES: criminal offence data (national police database); emotional and behavioural difficulties (self-report and parent/guardian reported); gang affiliation (self-report). Process evaluation: evaluation of acceptability and experiences of the CYP, parents/guardians, site staff and practitioners; fidelity of SFBT delivery. DISCUSSION: This two-arm individually RCT will evaluate the effectiveness of SFBT in reducing offending behaviours in CYP presenting at police custody suites within the area served by LSCFT. Our process evaluation will assess the fidelity of delivery of SFBT, the factors affecting implementation, the acceptability of SFBT in CYP aged 10-17 years and recruitment and reach. We will also examine systems and structures for future delivery, therefore assessing overall scalability. TRIAL REGISTRATION: ClinicalTrials.gov  ISRCTN14195235 . Registered on June 16, 2023.

Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts.

BACKGROUND/AIMS: The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University's Centre for Trials Research (CTR) in Wales, UK. We highlight facilitators of, and challenges to, integration. METHODS: We held group discussions on the work of the Qualitative Research Group (QRG) within CTR. The content of these discussions, materials for a presentation in CTR, and documents relating to the development of the QRG were interpreted at a workshop attended by group members. Normalisation Process Theory (NPT) was used to structure analysis. A writing group prepared a document for input from members of CTR, forming the basis of this paper. RESULTS: Actions to integrate qualitative research comprised: its inclusion in Centre strategies; formation of a QRG with dedicated funding/roles; embedding of qualitative research within operating systems; capacity building/training; monitoring opportunities to include qualitative methods in studies; maximising the quality of qualitative research and developing methodological innovation. Facilitators of these actions included: the influence of the broader methodological landscape within trial/study design and its promotion of the value of qualitative research; and close physical proximity of CTR qualitative staff/students allowing sharing of methodological approaches. Introduction of innovative qualitative methods generated interest among other staff groups. Challenges included: pressure to under-resource qualitative components of research, preference for a statistical stance historically in some research areas and funding structures, and difficulties faced by qualitative researchers carving out individual academic profiles when working across trials/studies. CONCLUSIONS: Given that CTUs are pivotal to the design and conduct of RCTs and related study types across multiple disciplines, integrating qualitative research into trials units is crucial if its contribution is to be fully realised. We have made explicit one trials unit's experience of embedding qualitative research and present this to open dialogue on ways to operationalise and optimise qualitative research in trials. NPT provides a valuable framework with which to theorise these processes, including the importance of sense-making and legitimisation when introducing new practices within organisations.

Adapting population health interventions for new contexts: qualitative interviews understanding the experiences, practices and challenges of researchers, funders and journal editors.

OBJECTIVES: Research on the adaptation of population health interventions for implementation in new contexts is rapidly expanding. This has been accompanied by a recent increase in the number of frameworks and guidance to support adaptation processes. Nevertheless, there remains limited exploration of the real-world experiences of undertaking intervention adaptation, notably the challenges encountered by different groups of stakeholders, and how these are managed. Understanding experiences is imperative in ensuring that guidance to support adaptation has practical utility. This qualitative study examines researcher and stakeholder experiences of funding, conducting and reporting adaptation research. SETTING: Adaptation studies. PARTICIPANTS: Participants/cases were purposefully sampled to represent a range of adapted interventions, types of evaluations, expertise and countries. Semistructured interviews were conducted with a sample of researchers (n=23), representatives from research funding panels (n=6), journal editors (n=5) and practitioners (n=3). MEASURES: A case study research design was used. Data were analysed using the framework approach. Overarching themes were discussed within the study team, with further iterative refinement of subthemes. RESULTS: The results generated four central themes. The first three relate to the experience of intervention adaptation (1) involving stakeholders throughout the adaptation process and how to integrate the evidence base with experience; (2) selecting the intervention and negotiating the mismatch between the original and the new context; and (3) the complexity and uncertainty when deciding the re-evaluation process. The final theme (4) reflects on participants' experiences of using adaptation frameworks in practice, considering recommendations for future guidance development and refinement. CONCLUSION: This study highlights the range of complexities and challenges experienced in funding, conducting and reporting research on intervention adaptation. Moving forward, guidance can be helpful in systematising processes, provided that it remains responsive to local contexts and encourage innovative practice.

Nurse-led home-visitation programme for first-time mothers in reducing maltreatment and improving child health and development (BB:2-6): longer-term outcomes from a randomised cohort using data linkage.

OBJECTIVES: Measure effectiveness of family nurse partnership (FNP) home-visiting programme in reducing maltreatment and improving maternal health and child health, developmental and educational outcomes; explore effect moderators, mediators; describe costs. DESIGN: Follow-up of BB:0-2 trial cohort (ISRCTN:23019866) up to age 7 years in England using record linkage. PARTICIPANTS: 1618 mothers aged 19 years or younger and their firstborn child(ren) recruited to BB:0-2 trial at less than 25 weeks gestation and not mandatorily withdrawn from trial or opted out. Intervention families were offered up to a maximum of 64 home visits by specially trained nurses from pregnancy until firstborn child was 2 years old, plus usually provided health and social care support. Comparator was usual care alone. OUTCOME MEASURES: Primary outcome: state-verified child-in-need status recorded at any time during follow-up. SECONDARY OUTCOMES: referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions any time during follow-up, early childcare and educational attendance, school readiness and attainment at key stage 1 (KS1), healthcare costs. RESULTS: Match rates for 1547 eligible children (1517 singletons, 15 sets of twins) were 98.3% (NHS Digital) and 97.4% (National Pupil Database). There was no difference between study arms in the proportion of children being registered as in need (adjusted OR 0.98, 95% CI 0.74 to 1.31), or for any other measure of maltreatment. Children in the FNP arm were more likely to achieve a good level of development at reception age (school readiness) (adjusted OR 1.24, 95% CI 1.01 to 1.52). After adjusting for birth month, children in FNP arm were more likely to reach the expected standard in reading at KS1 (adjusted OR 1.26, 95% CI 1.02 to 1.57). We found no trial arm differences for resource use and costs. CONCLUSIONS: FNP did not improve maltreatment or maternal outcomes. There was evidence of small advantages in school readiness and attainment at KS1. TRIAL REGISTRATION NUMBER: ISRCTN23019866.

Effectiveness of the Strengthening Families Programme in the UK at preventing substance misuse in 10-14 year-olds: a pragmatic randomised controlled trial.

OBJECTIVES: The Strengthening Families Programme 10-14 (SFP10-14) is a USA-developed universal group-based intervention aiming to prevent substance misuse by strengthening protective factors within the family. This study evaluated a proportionate universal implementation of the adapted UK version (SFP10-14UK) which brought together families identified as likely/not likely to experience/present challenges within a group setting. DESIGN: Pragmatic cluster-randomised controlled effectiveness trial, with families as the unit of randomisation and embedded process and economic evaluations. SETTING: The study took place in seven counties of Wales, UK. PARTICIPANTS: 715 families (919 parents/carers, 931 young people) were randomised. INTERVENTIONS: Families randomised to the intervention arm received the SFP10-14 comprising seven weekly sessions. Families in intervention and control arms received existing services as normal. OUTCOME MEASURES: Primary outcomes were the number of occasions young people reported drinking alcohol in the last 30 days; and drunkenness during the same period, dichotomised as 'never' and '1-2 times or more'. Secondary outcomes examined alcohol/tobacco/substance behaviours including: cannabis use; weekly smoking (validated by salivary cotinine measures); age of alcohol initiation; frequency of drinking >5 drinks in a row; frequency of different types of alcoholic drinks; alcohol-related problems. Retention: primary analysis included 746 young people (80.1%) (alcohol consumption) and 732 young people (78.6%) (drunkenness). RESULTS: There was no evidence of statistically significant between-group differences 2 years after randomisation for primary outcomes (young people's alcohol consumption in the last 30 days adjusted OR=1.11, 95% CI 0.72 to 1.71, p=0.646; drunkenness in the last 30 days adjusted OR=1.46, 95% CI 0.83 to 2.55, p=0.185). There were no statistically significant between-group differences for other substance use outcomes, or those relating to well-being/stress, and emotional/behavioural problems. CONCLUSIONS: Previous evidence of effectiveness was not replicated. Findings highlight the importance of evaluating interventions when they are adapted for new settings. TRIAL REGISTRATION NUMBER: ISRCTN63550893.Cite Now.

Preventing alcohol misuse in young people aged 9-11 years through promoting family communication: an exploratory evaluation of the Kids, Adults Together (KAT) Programme.

BACKGROUND: Alcohol misuse by young people is an important public health issue, and has led to the development of a range of prevention interventions. Evidence concerning the most effective approaches to intervention design and implementation is limited. Parental involvement in school-based interventions is important, but many programmes fail to recruit large numbers of parents. This paper reports findings from an exploratory evaluation of a new alcohol misuse prevention programme--Kids, Adults Together (KAT), which comprised a classroom component, engagement with parents through a fun evening for families with children aged 9-11 years, and a DVD. The evaluation aimed to establish the programme's theoretical basis, explore implementation processes and acceptability, and identify plausible precursors of the intended long-term outcomes. METHODS: Documentary analysis and interviews with key personnel examined the programme's development. Classroom preparation and KAT family events in two schools were observed. Focus groups with children, and interviews with parents who attended KAT family events were held immediately after programme delivery, and again after three months. Interviews with head teachers and with teachers who delivered the classroom preparation were conducted. Follow-up interviews with programme personnel were undertaken. Questionnaires were sent to parents of all children involved in classroom preparation. RESULTS: KAT achieved high levels of acceptability and involvement among both children and parents. Main perceived impacts of the programme were increased pro-social communication within families (including discussions about harmful parental alcohol consumption), heightened knowledge and awareness of the effects of alcohol consumption and key legal and health issues, and changes in parental drinking behaviours. CONCLUSIONS: KAT demonstrated promise as a prevention intervention, primarily through its impact on knowledge and communication processes within families, and its ability to engage with large numbers of parents. A key programme mechanism was the classroom preparation's facilitation of parental involvement in the family fun evening. The programme also incorporated features identified in the literature as likely to increase effectiveness, including a focus on harm reduction, interactive delivery, and targeting primary-school-age children. Further research is needed to test and develop programme theory through implementation in different school contexts, and to examine potential longer-term impacts, and the feasibility of large scale delivery.

What are the challenges when recruiting to a trial in children's social care? A qualitative evaluation of a trial of foster carer training.

BACKGROUND: Randomised controlled trials (RCTs) are comparatively rare in UK social work, but can offer distinct advantages. Confidence in Care (CiC) is an RCT with embedded process evaluation evaluating Fostering Changes (FC), a 12-week training programme for foster and kinship carers to increase skills and coping strategies. In order to mitigate challenges in participant recruitment, an engagement strategy was designed to maximise this. Our aim is to explore experiences of key study stakeholders towards trial recruitment and identify broader messages about recruitment to social care trials. METHODS: Three focus groups were conducted, two with field-based recruiting staff (n = 7) and one with carers who attended the FC programme (n = 8). Five interviews were conducted with trainers who delivered FC, eight with foster carers who attended the programme, 18 with Foster Carers who elected not to take part in the programme, and 12 with social workers from participating trial sites. In addition, an away day for FC trainers was observed and discussions related to recruitment were noted. Transcribed audio-recorded data were inductively coded, double-coded by a second researcher, and thematically analysed. RESULTS: Six themes were identified. The first addressed pragmatic aspects of the intervention affecting recruitment (e.g. committing to a 12-week programme). A second focussed on accuracy of communication about the trial between provider agencies and carers. A third concerned the ability of recruiting staff to contact carers, a particular challenge in group-based recruitment. A fourth addressed trial methods and their communication (e.g. relationship between trial team and recruiting staff). A fifth explored lack of differentiation by carers between the roles of the various professionals (e.g. FC facilitators and provider agencies). The sixth addressed perceived differences between recruitment into social care and health studies. CONCLUSIONS: Recruitment challenges in this social care setting were similar to those in healthcare. Some (e.g. gatekeeping by professional staff) may be rooted in randomisation anxiety, or unfamiliarity with research methods. Researchers more familiar with healthcare recruitment were however encouraged about the experience of working in this care setting. The original recruitment strategy and adaptations form the basis of further recommendations for research practice. TRIAL REGISTRATION: ISRCTN19090228 . Registered on 11 January 2017.

The what, why and when of adapting interventions for new contexts: A qualitative study of researchers, funders, journal editors and practitioners' understandings.

BACKGROUND: The adaptation of interventions for new contexts is a rapidly developing research area. To date there is no consensus-based guidance to support decision-making and recommend adaptation processes. The ADAPT study is developing such guidance. This aim of the qualitative component of the study was to explore stakeholders' understandings of adaptation, as to date there has limited consideration of how different concepts and meanings shape decision-making and practice. METHODS: A case study research design was used. Participants/cases were purposefully sampled based on study outcome, study design, expertise, context and country. Semi-structured interviews were conducted with a sample of researchers (n = 23); representatives from research funding panels (n = 6); journal editors (n = 5) and practitioners (n = 3). Data were analysed using the Framework approach. Overarching themes were discussed with the ADAPT study team, with further iterative refinement of subthemes. RESULTS: The results generated four central themes. Four themes related to stakeholders' understanding: 1) definitions of adaptation and related concepts; 2) rationales for undertaking adaptation; 3) the appropriate timing for adaptation; and 4) ensuring fidelity when implementing adapted interventions. CONCLUSION: The findings highlight the lack of clarity around key concepts and uncertainty about central decision-making processes, notably why interventions should be adapted, when and to what extent. This has informed the ADAPT study's guidance, shaping the scope and nature of recommendations to be included and surfacing key uncertainties that require future consideration.

Early Positive Approaches to Support (E-PAtS) for Families of Young Children With Intellectual Disability: A Feasibility Randomised Controlled Trial.

Background: Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and professionals, based on existing research evidence and a developmental systems approach to support parental mental well-being. The aim of this study was to assess the feasibility of community service provider organisations delivering E-PAtS to parents/family caregivers of young children with intellectual disability, to inform a potential definitive randomised controlled trial of the effectiveness and cost-effectiveness of E-PAtS. Methods: This study was a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to two parents/family caregivers of a child (18 months to <6 years old) with intellectual disability were recruited at research sites and allocated to intervention (E-PAtS and usual practise) or control (usual practise) on a 1:1 basis at cluster (family) level. Data were collected at baseline and 3 and 12 months' post-randomisation. The following feasibility outcomes were assessed: participant recruitment rates and effectiveness of recruitment pathways; retention rates; intervention adherence and fidelity; service provider recruitment rates and willingness to participate in a future trial; barriers and facilitating factors for recruitment, engagement, and intervention delivery; and feasibility of collecting outcome measures. Results: Seventy-four families were randomised to intervention or control (n = 37). Retention rates were 72% at 12 months post-randomisation, and completion of the proposed primary outcome measure (WEMWBS) was 51%. Recruitment of service provider organisations and facilitators was feasible and intervention implementation acceptable. Adherence to the intervention was 76% and the intervention was well-received by participants; exploratory analyses suggest that adherence and attendance may be associated with improved well-being. Health economic outcome measures were collected successfully and evidence indicates that linkage with routine data would be feasible in a future trial. Conclusions: The E-PAtS Feasibility RCT has demonstrated that the research design and methods of intervention implementation are generally feasible. Consideration of the limitations of this feasibility trial and any barriers to conducting a future definitive trial, do however, need to be considered by researchers. Clinical Trial Registration: https://www.isrctn.com, identifier: ISRCTN70419473.

Using a clinical pathway to support normal birth: impact on practitioner roles and working practices.

BACKGROUND: Widespread concerns are being voiced in the Western world about rising rates of childbirth intervention. In Wales, United Kingdom, a Clinical Pathway for Normal Labour (Normal Labour Pathway) was devised to support normal childbirth and reduce unnecessary interventions. This study investigated the implementation of the pathway, from the perspective of midwives, doctors, and midwifery managers. METHODS: An ethnographic approach was used to observe use of the Normal Labour Pathway in real life settings and evaluate its implementation. Data were collected by means of semiparticipant observation, focus groups, and interviews. Participants (n = 56) included senior practitioners involved in creating the pathway (n = 4), midwives (n = 41), managers (n = 5), and doctors (n = 6). Data were analyzed thematically. RESULTS: Key themes related to the effect of the Normal Labour Pathway on Welsh maternity care, and midwives' and doctors' experiences. Midwives' views focused on the pathway as a decision-making protocol and record of care. Recently qualified midwives were more likely to view the pathway positively than those with more experience. Doctors were critical of the pathway, experiencing it as exclusionary. Midwives and doctors considered that the Normal Labour Pathway had increased interprofessional tensions. There was no evidence that it had increased the normal birth rate. CONCLUSIONS: The Normal Labour Pathway is a complex intervention with complex outcomes. It has had intended and unintended consequences, for maternity care in general and for the roles and relationships of maternity care practitioners. The study raises questions about the appropriateness of clinical pathways and other standardized decision-making tools for the complexity of childbirth.

Ecological Exploration of Knowledge and Attitudes Towards Tobacco and E-Cigarettes Among Primary School Children, Teachers, and Parents in Wales: A Qualitative Study.

Experimentation with e-cigarettes has grown rapidly among UK adolescents. To date, this topic has been primarily researched in secondary schools, with less understanding of development of attitudes and behaviours at an earlier age. This research reports qualitative data from interviews with pupils, parents, and teachers at 4 case study schools in Wales (N = 42). It draws on Bronfenbrenner's Ecological Systems Theory to consider how the intersection of systems surrounding primary school-age children and their interaction with these systems, shape knowledge, and attitudes towards e-cigarettes and tobacco. Findings indicate that consistent messaging on smoking from school and family was reflected in strong disapproval among pupils and clear understanding of harms. This was less evident for e-cigarettes, where messages were mixed and inconsistent between home and school, with concerns over what to tell children about e-cigarettes in light of mixed messages and absence of official guidance. Implications of findings for policy and teaching are discussed.

Associations of Socioeconomic Status, Parental Smoking and Parental E-Cigarette Use with 10-11-Year-Old Children's Perceptions of Tobacco Cigarettes and E-Cigarettes: Cross Sectional Analysis of the CHETS Wales 3 Survey.

BACKGROUND: This study examines primary schoolchildren's perceptions of e-cigarettes and tobacco cigarettes, and associations with parental smoking, vaping and socioeconomic status. METHODS: Survey of 2218 10-11-year-old children in 73 schools in Wales. RESULTS: Overall, 36% reported that a parent figure smoked compared to 21% for vaping, with parental smoking lower in affluent families (OR = 0.72; 95% CI = 0.68 to 0.76). Overall, 1% had tried a cigarette, while 5% had tried an e-cigarette. Most said they would not smoke or vape in 2 years' time; susceptibility to vaping (20%) was higher than smoking (12%). Exposure to and perceptions of tobacco cigarettes were more positive for children of smokers. Having a parent who vaped was associated with exposure to and positive perceptions of e-cigarettes, but not smoking. Most children perceived e-cigarettes as used by adults to stop smoking (64%). Susceptibility to smoking (OR = 0.57; 95% CI = 0.41 to 0.79) and vaping (OR = 0.78; 95% CI = 0.62 to 0.99) were lower among children who perceived e-cigarettes as cessation aids. CONCLUSIONS: Parental smoking continues to be concentrated in poorer families. This study provides no evidence that parental vaping in the absence of smoking is associated with more positive perceptions of tobacco cigarettes. Communicating to children the role of e-cigarettes as cessation devices for smokers may help to limit their appeal to young people.

The Early Positive Approaches to Support (E-PAtS) study: study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability.

BACKGROUND: Children with intellectual disability have an IQ < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems. In addition, parents of children with intellectual disability are likely to report high levels of mental health and other psychological problems. The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children. The aim of this study is to assess the feasibility of delivering E-PAtS to family caregivers of children with intellectual disability by community parenting support service provider organisations. The study will inform a potential, definitive RCT of the effectiveness and cost-effectiveness of E-PAtS. METHODS: This study is a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to 2 family caregivers will be recruited from 64 families with a child (18 months to 5 years) with intellectual disability at research sites in the UK. Participating families will be allocated to intervention: control on a 1:1 basis; intervention families will be offered the E-PAtS programme immediately, continuing to receive usual practice, and control participants will be offered the opportunity to attend the E-PAtS programme at the end of the follow-up period and will continue to receive usual practice. Data will be collected at baseline, 3 months post-randomisation and 12 months post-randomisation. The primary aim is to assess feasibility via the assessment of: recruitment of service provider organisations; participant recruitment; randomisation; retention; intervention adherence; intervention fidelity and the views of participants, intervention facilitators and service provider organisations regarding intervention delivery and study processes. The secondary aim is preliminary evaluation of a range of established outcome measures for individual family members, subsystem relationships and overall family functioning, plus additional health economic outcomes for inclusion in a future definitive trial. DISCUSSION: The results of this study will inform a potential future definitive trial, to evaluate the effectiveness and cost-effectiveness of the E-PAtS intervention to improve parental psychosocial wellbeing. Such a trial would have significant scientific impact internationally in the intellectual disability field. TRIAL REGISTRATION: ISRCTN70419473.