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.

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.

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.

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.

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.

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.

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.

Harnessing collaboration to build nursing research capacity: a research team journey.

This paper discusses a qualitative evaluation study, designed to explore nursing lecturers' research capability development through their engagement as co-researchers in a larger case study project (referred to as the 'main project'). It explores the justification for supporting research capacity development using this collaborative approach, the process and experience of undertaking collaborative research, and the effectiveness of this model of collaboration in developing new researchers. The paper also makes connections between the process of undertaking the research (designed to offer opportunities for inexperienced researchers to be involved) and the main project findings (which explored the ways in which academic schools develop research capacity). We first set the main project in its wider context and map key issues relating to research capacity development and collaboration in the literature, before outlining how we involved neophyte and 'midiphyte' researchers. The evaluative study, which is the focus of this paper, discusses the experiences of the neophyte researchers, and explores the synergies between the main project's key findings and the process of undertaking it. We conclude with some principles for using collaboration to build research capacity, visualised through a conceptual model. While this project was located within two universities in the UK, the development of research skills amongst nurses is likely to have broad international relevance. NB1 References to 'nursing', 'nursing research', and 'nursing education' are taken throughout to apply equally to midwifery, midwifery research, and midwifery education. NB2 For the purpose of this project, neophyte researchers are defined as staff needing formal training in research and involvement in others' research, and 'midiphyte' researchers as those with some training but needing support to develop research ideas.

Challenges and strategies in developing nursing research capacity: a review of the literature.

OBJECTIVES: This paper reports the findings of a critical overview of the development of nursing research capacity in academic departments. It examines the major barriers to developing research capacity, the capacity building strategies adopted (or proposed) within the literature, and considers the wider context within which such endeavours take place. DESIGN: The literature review forms part of a longitudinal project utilising case study methodology. A key word search was used to locate relevant journal articles for the period 1999-2004, derived from the project's research question and an earlier literature review. A number of manual 'shelf searches' were conducted. DATA SOURCES: Bibliographic data were retrieved from The Cumulative Index of Nursing and Allied Health literature, The Social Science Citation Index, and Medline. REVIEW METHODS: Approximately 150 articles were retrieved, of which 47 were included in the study. Given the paucity of work in this area papers were not excluded on the grounds of methodological weakness. Major themes were identified in each paper and an analytical framework was developed. RESULTS: Two main challenges affecting research capacity development were identified-material constraints and organisational contexts, and the changing roles and expectations of nurse educators. The importance of developing an overall strategic approach, clearly communicated, and accompanied by effective leadership was a point of common agreement. Debate existed on how research support should be managed, particularly the merits of inclusivity and the reconcilement of individual and organisational needs. Specific capacity strategies identified in the literature were the creation of infrastructures, the fostering of research cultures and environments, and the facilitation of training and collaboration. CONCLUSIONS: The literature offers many examples of capacity building strategies. However, more empirical studies are needed to understand the situated process of implementing and evaluating capacity building in individual academic departments, and how this process differs between geographical settings.