Is it feasible to nest a Trial within a Cohort Study (TwiCS) to evaluate an early years parenting programme? A Born in Bradford's Better Start study protocol.

BACKGROUND: Evaluating the effectiveness of early years parenting interventions provides evidence to improve the development and wellbeing of children. This protocol paper describes a study to explore the feasibility of evaluating the Incredible Years Toddler early life intervention programme, which is offered to parents of 1-3-year-olds via the Better Start Bradford programme. The study aims to use a Trial within a Cohort Study (TwiCS) design that randomly selects individuals participating in a cohort to be offered an intervention. The TwiCS information and consent process is person-centred and aims to replicate real-world practice whereby only those who are offered the intervention are given information about the intervention. The cohort is the Born in Bradford's Better Start (BiBBS) cohort, an interventional birth cohort recruiting expectant parents in three areas of Bradford, UK. The study will assess the feasibility of TwiCS procedures, staged consent, and intervention take-up. METHODS: We will conduct a feasibility TwiCS to test study procedures. We aim to establish the following: (1) whether TwiCS methodology can be implemented to create control and intervention arms, whilst documenting any incidences of contamination within the cohort; (2) whether satisfactory rates of intervention uptake are achieved among participants allocated to the intervention; and (3) whether satisfactory rates of retention of participants in the intervention can be achieved. A Red Amber Green (RAG) rating system has been applied to support the feasibility assessment of each objective: to be rated red (not achieved), amber (partly achieved), and green (achieved). Eligible participants in the BiBBS cohort will be individually randomised 1:1 to the intervention or control arms, with stratification by child age (1 or 2 years old at the time of randomisation) and ethnicity (White British, South Asian, or other). BiBBS researchers will seek consent from participants randomised to the intervention to pass their contact details onto Incredible Years' delivery agents. DISCUSSION: This feasibility study will inform the utility of the TwiCs approach within an experimental birth cohort to evaluate interventions for infants, toddlers, and their families. TRIAL REGISTRATION: The study was prospectively registered on ISRCTN (ISRCTN16150114).

Effectiveness of a midwife-led continuity of care model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot, process evaluation and economic analysis.

INTRODUCTION: Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population. METHODS AND ANALYSIS: An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives' and women's perspectives. ETHICS AND DISSEMINATION: Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings. TRIAL REGISTRATION NUMBER: IsRCTNhttps://doi.org/10.1186/ISRCTN31836167.

A quasi-experimental effectiveness evaluation of the 'Incredible Years Toddler' parenting programme on children's development aged 5: A study protocol.

Child behavioural and mental health problems have become a public health crisis. The consequences of poor mental health in childhood have large economic costs and consequences for the individual, their families, and for society. Early intervention through parenting programmes can reduce the onset of poor mental health in childhood, hence evaluating the effectiveness of parenting programmes is critical. The 'Incredible Years Toddler' parent programme is an education and training intervention designed to enhance the social and emotional wellbeing of children aged 1-3 years. Whilst previous studies show Incredible Years Toddler to provide promising effects on child outcomes in the short term, the research samples have lacked ethnic diversity and representation from socioeconomically deprived families. This quasi-experimental study is registered on ISRCTN (ISRCTN49991769). We will investigate the effectiveness of Incredible Years Toddler being delivered in three neighbourhoods in inner city Bradford, England. These neighbourhoods contain a socially and ethnically diverse population with 84% living in the poorest decile for England and Wales. Parents with a child aged 1-3 years old who are enrolled in Born in Bradford's Better Start interventional family cohort study are eligible for this study. Intervention participants will be matched to a demographically comparable control group using propensity score matching. This study will use retrospective and prospective data from participants who attended Incredible Years groups between September 2018 and April 2024. The required minimum sample is n = 1336 (ratio 1:3) to detect a small effect (odds = 1.5, d = .20) on the Early Years Foundation Stage profile total score at age 5; a measure of early child development that is routinely collected by teachers. We will also establish whether these effects are moderated by child age at entry to intervention, programme delivery mode, socioeconomic status, and ethnicity. We will also estimate the cost of the intervention and conduct a cost-consequence analysis.

Predictors of Mother and Infant Emergency Department Attendance and Admission: A Prospective Observational Study.

OBJECTIVE: To explore the predictors of emergency department attendance and admission for mothers and their infants. METHODS: Self-reported emergency department (ED) attendance and admission, sociodemographic, mental health, and other measures were recorded at baseline and at 12 months at 4 sites in England between May 2017 and March 2020. RESULTS: Infants' gestational age (OR 0.73, 95% CI 0.61 to 0.88, p = 0.001), mothers' mental health (OR 2.40, 95% CI 1.30 to 4.41, p = 0.005) and mothers' attendance at ED (OR 2.34, 95% CI 1.13 to 4.84, p = 0.022) predicted infant ED attendance. Frequency of attendance was predicted by ED site (IRR 0.46, 95% CI 0.29 to 0.73, p = 0.001) and mothers' age (IRR 0.96, 95% CI 0.92 to 1.00, p = 0.028). Infant hospital admissions were predominantly for respiratory (40%) and other infectious diseases (21%) and were predicted by previous health problems (OR 3.25, 95% CI 1.76 to 6.01, p < 0.001). Mothers' ED attendance was predicted by mixed or multiple ethnic origin (OR 9.62, 95% CI 2.19 to 42.27, p = 0.003), having a male infant (OR 2.08, 95% CI 1.03 to 4.20, p = 0.042), and previous hospitalisation (OR 4.15, 95% CI 1.81 to 9.56, p = 0.001). Hospital admission was largely for reproductive health issues (61%) with frequency predicted by having attended the ED at least once (IRR 3.39, 95% CI 1.66 to 6.93, p = 0.001), and being anxious or depressed (IRR 3.10, 95% CI 1.14 to 8.45, p = 0.027). CONCLUSIONS FOR PRACTICE: Improving the reproductive and mental health of mothers may help to avoid poor maternal and infant health outcomes and reduce emergency service utilisation and hospitalisation.

Protocol for the effectiveness evaluation of an antenatal, universally offered, and remotely delivered parenting programme 'Baby Steps' on maternal outcomes: a Born in Bradford's Better Start (BiBBS) study.

BACKGROUND: Poor perinatal mental health and maternal sensitivity towards a child in the early years can carry a long-term cost to individuals and to society, and result in negative child outcomes such as poor mental health and social emotional issues. Despite the recognition of early intervention and prevention, there is mixed evidence regarding antenatal parenting interventions that aim to enhance perinatal mental health and maternal sensitivity to prevent negative child outcomes. 'Baby Steps' is a relationship-based antenatal and postnatal parenting programme. The service evaluated in this study is delivered in a low-income and ethnically diverse community via Better Start Bradford. This study aims to assess whether the universally, and remotely delivered Baby Steps programme is effective in improving postnatal maternal sensitivity (primary outcome) and postnatal maternal mental health (secondary outcome) when compared to services as usual 6-10 weeks post-birth. It will also assess differences in birth outcomes, and differences in the prevalence of poor perinatal mental ill health through routine data. The feasibility of collecting cost and health related resource use data for a future economic evaluation will be explored. METHODS: The study is a quasi-experimental evaluation in a single centre. All participants are drawn from Born in Bradford's Better Start (BiBBS) interventional family cohort study. Intervention participants will be matched to a demographically comparable control group using propensity score matching. The required minimum sample is n = 130 (ratio 1:1) to detect a medium effect (± 2.35, d = .50) on the primary outcome-maternal-child sensitivity, using the Mothers Object Relations Scale Short Form (MORS-SF). Secondary outcomes include the Patient Health Questionnaire (PHQ-8), Generalised Anxiety Disorder assessment 7 (GAD-7), identification of poor perinatal mental health through routine data, and birth outcomes (delivery method, gestation period, low birth weight). Service delivery costs and health resource use will be gathered from routine data. DISCUSSION: This study will evaluate the effectiveness of Baby Steps for enhancing maternal-child sensitivity and maternal mental health when delivered universally and remotely. The findings regarding programme effectiveness, process, and costs will be relevant for researchers, service commissioners, and service staff. TRIAL REGISTRATION: This study was prospectively registered with ISRCTN (22/04/2022, ISRCTN12196131).

The feasibility of an objective measure of the parent-child relationship in health visiting practice: assessment of the Maternal Postnatal Attachment Scale.

Background: Positive parent infant relationships are key to achieving long term child outcomes. Identifying parents who may need support is difficult because of a lack of robust assessment tools. Working in partnership with health services we piloted the Maternal Postnatal Attachment Scale (MPAS) in a deprived, multi-ethnic urban community in Bradford, UK. The pilot aimed to assess the clinical utility of MPAS to identify need for support: Was it administered to a representative group of women? Is MPAS valid for this population? Methods: Data were linked to a cohort study in the pilot area (Born in Bradford's Better Start - BiBBS). Chi Square tests assessed sample representativeness (age, ethnicity, parity, English language, education, deprivation). Exploratory factor analysis explored MPAS' validity. Results: 563 women in BiBBS were eligible, 210 (37%) completed MPAS.  No differences were found between completers and non-completers, suggestive of a representative sample. In total, 336 women completed MPAS in the pilot.  MPAS had ceiling effects and a satisfactory factor structure could not be identified, indicating poor psychometric properties Conclusions: Health visitors were successful in administering MPAS to a representative sample, but poor psychometric robustness indicates that MPAS is unsuitable for routine use in this setting. A gap for such a measure remains.

Barriers and facilitators in the delivery of a proportionate universal parenting program model (E-SEE Steps) in community family services.

BACKGROUND: A proportionate universal (PU) approach to early years' service provision has been advocated to improve children's health and development and to reduce health inequality, by ensuring that services provide timely and high-quality parenting support commensurate with need. Process-oriented research is critical to examine the factors that contribute to, or hinder, the effective delivery/implementation of such a model in community-based family services. This study aimed to assess the delivery, acceptability and feasibility of a new PU parenting intervention model (called E-SEE Steps), using the Incredible Years® (IY) parent program, when delivered by trained health/family service staff in three "steps"-one universal step (the IY Babies Book), and two targeted steps (group-based IY Infant and Toddler programs). METHODS: An embedded mixed-methods process evaluation within a pragmatic parallel two-arm, assessor blinded, randomized controlled trial was conducted in community services in four local authorities in England. The process evaluation used qualitative data gathered via interviews and focus groups with intervention arm parents who were offered the targeted steps (n = 29), practitioners (n = 50), service managers (n = 7) and IY program mentors (n = 3). This was supplemented by quantitative data collected using group leader pre-training (n = 50) and post-delivery (n = 39) questionnaires, and research notes of service design decisions. RESULTS: The E-SEE Steps model was acceptable to most parents, particularly when it was accompanied by engagement strategies that supported attendance, such as providing childcare. Practitioners also highlighted the positive development opportunities provided by the IY training and supervision. However, participant views did not support the provision of the IY Babies book as a standalone universal component, and there were barriers to eligible parents-particularly those with low mood-taking up the targeted programs. Service providers struggled to align the PU model with their commissioned service contracts and with their staff capacity to engage appropriate parents, including tackling common barriers to attendance. CONCLUSIONS: Despite general enthusiasm and support for delivering high-quality parenting programs in community services in the England, several barriers exist to successfully delivering IY in a proportionate universal model within current services/systems.

The cost-effectiveness of a proportionate parenting programme for primary caregivers and their child: an economic evaluation using evidence from the E-SEE Trial.

BACKGROUND: Behavioural and mental disorders have become a public health crisis; averting mental ill-health in early years can achieve significant longer-term health benefits and cost savings. This study assesses whether the Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE-Steps)-a proportionate universal delivery model comprising the Incredible Babies book (IY-B) and the Incredible Years Infant (IY-I) and Toddler (IY-T) parenting programmes is cost-effective compared to services as usual (SAU) for the primary caregiver, child and dyad. METHODS: Using UK data for 339 primary caregivers from the E-SEE trial, we conducted a within-trial economic evaluation assessing the cost-effectiveness of E-SEE Steps. Health outcomes were expressed in quality-adjusted life-years (QALY) and costs in UK pounds sterling (2018-19). Missing data were populated via multiple imputation and costs and QALYs discounted at 3.5% per annum. Cost-effectiveness results were conducted for primary caregivers, children and dyad using econometric modelling to control for patient co-variables. Uncertainty was explored through scenario and sensitivity analyses. RESULTS: The average cost of E-SEE Steps intervention was £458.50 per dyad. E-SEE Steps was associated with modest gains in primary caregiver HRQoL but minor decrements in child HRQoL compared to SAU. For primary caregivers, E-SEE Steps was more effective (0.034 QALYs) and more costly (£446) compared to SAU, with a corresponding incremental cost-effectiveness ratio (ICER) of £13,011 per QALY. In children, E-SEE Steps was strictly dominated with poorer outcomes (-0.005 QALYs) and greater costs (£178) relative to SAU. QALY gains in primary caregivers exceeded those QALY losses found in children, meaning E-SEE Steps was more effective (0.031 QALYs) and costly (£621) for the dyad (ICER: £20,062 per QALY). All scenario analyses found E-SEE Steps cost-effective for the dyad at a £30,000 per QALY threshold. Sensitivity analyses found significant cost reductions from expansions in programme delivery and attendance. CONCLUSIONS: E-SEE Steps achieved modest health gains in primary caregivers but small negative effects on children and was more costly than SAU. E-SEE Steps appears cost-effective for the dyad, but the results should be interpreted with caution given the potential detrimental impact on children. TRIAL REGISTRATION: ISRCTN11079129 ; Pre participant trial enrolment, 11/05/2015.

A randomized controlled trial of a proportionate universal parenting program delivery model (E-SEE Steps) to enhance child social-emotional wellbeing.

BACKGROUND: Evidence for parenting programs to improve wellbeing in children under three is inconclusive. We investigated the fidelity, impact, and cost-effectiveness of two parenting programs delivered within a longitudinal proportionate delivery model ('E-SEE Steps'). METHODS: Eligible parents with a child ≤ 8 weeks were recruited into a parallel two-arm, assessor blinded, randomized controlled, community-based, trial with embedded economic and process evaluations. Post-baseline randomization applied a 5:1 (intervention-to-control) ratio, stratified by primary (child social-emotional wellbeing (ASQ:SE-2)) and key secondary (maternal depression (PHQ-9)) outcome scores, sex, and site. All intervention parents received the Incredible Years® Baby Book (IY-B), and were offered the targeted Infant (IY-I)/Toddler (IY-T) program if eligible, based on ASQ:SE-2/PHQ-9 scores. Control families received usual services. Fidelity data were analysed descriptively. Primary analysis applied intention to treat. Effectiveness analysis fitted a marginal model to outcome scores. Cost-effectiveness analysis involved Incremental Cost-Effectiveness Ratios (ICERs). RESULTS: The target sample (N = 606) was not achieved; 341 mothers were randomized (285:56), 322 (94%) were retained to study end. Of those eligible for the IY-I (n = 101), and IY-T (n = 101) programs, 51 and 21 respectively, attended. Eight (of 14) groups met the 80% self-reported fidelity criteria. No significant differences between arms were found for adjusted mean difference scores; ASQ:SE-2 (3.02, 95% CI: -0.03, 6.08, p = 0.052), PHQ-9 (-0.61; 95% CI: -1.34, 0.12, p = 0.1). E-SEE Steps had higher costs, but improved mothers' Health-related Quality of Life (0.031 Quality Adjusted Life Year (QALY) gain), ICER of £20,062 per QALY compared to control. Serious adverse events (n = 86) were unrelated to the intervention. CONCLUSIONS: E-SEE Steps was not effective, but was borderline cost-effective. The model was delivered with varying fidelity, with lower-than-expected IY-T uptake. Changes to delivery systems and the individual programs may be needed prior to future evaluation. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number: ISRCTN11079129.

The Measurement Properties and Acceptability of a New Parent-Infant Bonding Tool ('Me and My Baby') for Use in United Kingdom Universal Healthcare Settings: A Psychometric, Cross-Sectional Study.

INTRODUCTION: The National Institute for Health and Care Excellence (NICE) guidelines acknowledge the importance of the parent-infant relationship for child development but highlight the need for further research to establish reliable tools for assessment, particularly for parents of children under 1 year. This study explores the acceptability and psychometric properties of a co-developed tool, 'Me and My Baby' (MaMB). STUDY DESIGN: A cross-sectional design was applied. The MaMB was administered universally (in two sites) with mothers during routine 6-8-week Health Visitor contacts. The sample comprised 467 mothers (434 MaMB completers and 33 'non-completers'). Dimensionality of instrument responses were evaluated via exploratory and confirmatory ordinal factor analyses. Item response modeling was conducted via a Rasch calibration to evaluate how the tool conformed to principles of 'fundamental measurement'. Tool acceptability was evaluated via completion rates and comparing 'completers' and 'non-completers' demographic differences on age, parity, ethnicity, and English as an additional language. Free-text comments were summarized. Data sharing agreements and data management were compliant with the General Data Protection Regulation, and University of York data management policies. RESULTS: High completion rates suggested the MaMB was acceptable. Psychometric analyses showed the response data to be an excellent fit to a unidimensional confirmatory factor analytic model. All items loaded statistically significantly and substantially (>0.4) on a single underlying factor (latent variable). The item response modeling showed that most MaMB items fitted the Rasch model. (Rasch) item reliability was high (0.94) yet the test yielded little information on each respondent, as highlighted by the relatively low 'person separation index' of 0.1. CONCLUSION AND NEXT STEPS: MaMB reliably measures a single construct, likely to be infant bonding. However, further validation work is needed, preferably with 'enriched population samples' to include higher-need/risk families. The MaMB tool may benefit from reduced response categories (from four to three) and some modest item wording amendments. Following further validation and reliability appraisal the MaMB may ultimately be used with fathers/other primary caregivers and be potentially useful in research, universal health settings as part of a referral pathway, and clinical practice, to identify dyads in need of additional support/interventions.

Implementing the Maternal Postnatal Attachment Scale (MPAS) in universal services: Qualitative interviews with health visitors.

Background: A secure parent-infant relationship lays the foundations for children's development, however there are currently no measurement tools recommended for clinical practice. We evaluate the clinical utility of a structured assessment of the parent-infant relationship (the Maternal Postnatal Attachment Scale, MPAS) in a deprived, multi-ethnic urban community in England. This paper answers the question: what are health visitors' views on the parent-infant relationship, and experiences of piloting the MPAS? It explores the barriers and facilitators to implementation, and complements the paper on psychometric properties and representativeness reported in Dunn et al (submitted).   Methods: Semi-structured interviews were conducted with 11 health visitors and data were analysed using thematic analysis.  Results: Health visitors saw identification and support of the parent-infant relationship as an important part of their role, and reported benefits of the MPAS, including opening conversation, and identifying and reporting concerns. Challenges included timing and workload, the appropriateness of language, perceived intrusiveness and understanding of the questions, and the length of the tool. Suggestions for improvements to the tool were put forwards.  Conclusions: The experiences, benefits and challenges identified help to explain results in Dunn et al, and the wide-ranging challenges identified would hinder assessment of the parent-infant relationship in routine practice. Further work with health professionals and parents has been undertaken to co-produce an acceptable, feasible and reliable tool for clinical practice.

The challenges of assessing sample representativeness within community-based evaluations of parenting programmes delivered in England and Ireland.

The findings from evaluations of parenting programmes can help inform policy and practice decisions, including how best to allocate scarce resources designed to support families. However, studies often fail to consider the extent to which the findings can be generalised to other settings or populations. One, yet unexplored solution, is to compare study findings and large-scale data sets including publicly available population data. The aims of this study were to assess the feasibility of assessing sample representativeness using publicly available data and to identify the challenges involved in considering the generalisability of study findings. Sociodemographic data from two community-based evaluations of parenting programmes conducted in England and Ireland between 2015 and 2018 were used in the study (N = 395 parent-infant dyads). The results indicated some differences between the trial samples and the wider population. However, it is difficult to reach definitive conclusions about these findings due to the limitations associated with using the comparative data sets. Our study revealed three key challenges, including: (1) how best to define and conceptualise representativeness; (2) the availability of comparative data sets; and (3) the quality of the available data. Our study suggests that there is a need for up-to-date, good-quality comparative data sets to allow for the assessment of representativeness. Further work is required to identify parameters for making claims about representativeness, specifically regarding the acceptable level of difference between the target population and the study sample. This is the first study to explore the feasibility of using publicly available population data in two jurisdictions, for the purpose of making judgements about the representativeness of the findings from parent programmes. It is hoped that our results will encourage further investigation around the reporting of trial external validity to enable effective decision-making at policy and practice level.

What do parents think of using informational videos to support recruitment for parenting trials? A qualitative study.

BACKGROUND: Lower than expected recruitment and retention rates are common challenges in parenting trials-particularly for community-based trials targeting parents of young children that rely on face-to-face recruitment by frontline workers. Recruitment requires parental informed consent, yet information sheets have been criticized for being lengthy and complex, and particularly challenging for parents with low literacy. Recent innovations include 'talking head' information videos. This paper aims to explore parent perceptions of using a 'talking head' video to support informed consent, recruitment, and retention procedures in parenting trials. METHODS: We conducted semi-structured interviews with a sample of 24 mothers recruited after their final follow-ups in two different parenting trials in Denmark. Before consenting to participate in the trials, parents were invited to view a video of a member of the study team giving information about the study, and again before the interviews for the current study. The audio data was transcribed and thematic analysis was conducted. RESULTS: We identified three overarching themes: (1) general impression of the video, (2) thoughts on participation in research, and (3) recruitment and retention. Participants were generally positive in their appraisal of the two talking head informational videos. We found that participants felt that a mix of paper-based and video-based sources of information would enable them to make an informed choice about whether to participate in a research study. We also found that a professionally produced video featuring a key member of the study team produced a feeling of commitment to the study that could impact retention rates. CONCLUSIONS: Informational videos are acceptable to parents; however, co-production or participant/patient involvement in the development of such videos is recommended. Informational videos may not increase recruitment but have the potential for improving retention. Key design recommendations are to ensure a 'professional' look to the video, to supplement videos with paper-based information, to keep the length to < 3 min, and for the 'talking head' part to feature a key member of the study team.

Inequalities in the identification and management of common mental disorders in the perinatal period: An equity focused re-analysis of a systematic review.

OBJECTIVE: Maternal mental health problems in the perinatal period can cause significant distress and loss of functioning, and can have lasting impact on children. People living in disadvantage are at risk of health inequalities, including for perinatal mental health. A review of current guidance found that overall implementation of the UK detection and management strategy was satisfactory, but equity was not considered in the review. Greater understanding of implementation equity is needed. We aimed to reanalyse an existing systematic review on the implementation of current guidance for the identification and management of perinatal mental health problems for equity. METHODS: Studies reporting the presence or absence of variation by a social, economic or demographic group were quality appraised and the presence and direction of disparity tabled. We calculated standardised absolute prevalence estimates for overall detection and management, and absolute and relative estimates by determinants grouping. A thematic analysis of the studies that examined potential reasons for disparity was undertaken. RESULTS: Six studies, with no major quality concerns, provided consistent evidence of reduced identification and management for ethnic minority women, both those who do, and do not, speak English. There was less consistent evidence of inequality for other axes of social disparity and for characteristics such as age, parity and partnership status. Explanations centred on difficulties that translation and interpretation added to communication, and hesitancy related to uncertainty from healthcare providers over cultural understanding of mental health problems. CONCLUSION: The identification and management of perinatal mental health problems is likely to be inequitable for ethnic minority women. Further systems-based research should focus on clarifying whether other groups of women are at risk for inequalities, understand how mismatches in perception are generated, and design effective strategies for remediation. Inequalities should be considered when reviewing evidence that underpins service planning and policy decision-making.

"Putting Meat on the Bones": Understanding the Implementation of a Community-Based Early Intervention and Prevention Programme-Contextual, Person, and Programme Influences.

The adoption and effective delivery of evidence-based interventions within "real-world" community-based, primary health care service settings are of crucial importance. In this paper, we explore the successes and challenges of implementing a new complex, group-based, early parenting intervention called the Parent and Infant (PIN) programme. This study involved a systematic analysis of the processes and factors that influence the implementation of the PIN programme; the analysis was guided and informed by the Implementation Outcome Framework and the Consolidated Framework for Implementation Research. A documentary review, alongside a series of one-to-one interviews and small group discussions with a range of stakeholders (n = 44), and 7 focus groups (n = 24) were used as data sources. Factors that promoted programme adoption, acceptability, and implementation feasibility included programme characteristics and stakeholder attitudes, as well as organisational and systems factors (e.g. leadership and collaboration). Key challenges to implementation success included engagement and adoption barriers. This research provides a useful and important example of real-world, theory-driven implementation research which helped to identify interrelated processes, factors, and contexts which shape and influence the implementation of early intervention and prevention programmes, removed for blind review.

A feasibility evaluation of the Incredible Years® School Readiness parenting programme / La evaluación de la viabilidad del programa para la mejora de las habilidades parentales Incredible Years® School Readiness

Parental involvement in their children's education, including activities undertaken by parents at home and through strong links with their children's schools, contributes to children's academic attainment. This study examined whether it was feasible for school-based staff to deliver the Incredible Years® School Readiness parent programme (IY-SR) in schools, its acceptability to parents and teachers, its impact on home-school relationships, and preliminary programme impact. Thirty-two parents with a child in a nursery or reception class were recruited from eight schools. Group leaders and parents gave positive feedback about the programme and parental attendance on the programme was high. There were also significant increases in parents' use of praise and children's positive responses. This is the first study to demonstrate the feasibility of engaging schools to deliver the IY-SR programme as a means of promoting home-school relationships and providing parents with the skills to coach their children's school readiness skills

La implicación de las figuras parentales en la educación de sus hijos e hijas, incluyendo las actividades llevadas a cabo en el hogar, y una buena relación familia-escuela, contribuye al rendimiento académico de los niños y las niñas. Este estudio evalúa la viabilidad de la implementación del programa Incredible Years® School Readiness (IY-SR), su aceptación por parte de las familias y de los maestros y las maestras, su impacto en la relación familia-escuela y los resultados preliminares de su efectividad. Treinta y dos figuras parentales con hijos e hijas en guardería o en escuela infantil fueron captadas en ocho centros. Los dinamizadores y las figuras parentales mostraron una respuesta positiva hacia el programa y la asistencia de las familias a este fue alta. Además, se incrementó el uso de elogios por parte de las figuras parentales y las respuestas positivas de sus hijos e hijas. Este es el primer estudio que demuestra la viabilidad de involucrar a los centros educativos en la implementación del programa IY-SR como medio para promover la relación familia-escuela y capacitar a las figuras parentales para fomentar las competencias de sus hijos e hijas en su preparación para la escuela

ActEarly: a City Collaboratory approach to early promotion of good health and wellbeing.

Economic, physical, built, cultural, learning, social and service environments have a profound effect on lifelong health. However, policy thinking about health research is dominated by the 'biomedical model' which promotes medicalisation and an emphasis on diagnosis and treatment at the expense of prevention. Prevention research has tended to focus on 'downstream' interventions that rely on individual behaviour change, frequently increasing inequalities. Preventive strategies often focus on isolated leverage points and are scattered across different settings. This paper describes a major new prevention research programme that aims to create City Collaboratory testbeds to support the identification, implementation and evaluation of upstream interventions within a whole system city setting. Prevention of physical and mental ill-health will come from the cumulative effect of multiple system-wide interventions. Rather than scatter these interventions across many settings and evaluate single outcomes, we will test their collective impact across multiple outcomes with the goal of achieving a tipping point for better health. Our focus is on early life (ActEarly) in recognition of childhood and adolescence being such critical periods for influencing lifelong health and wellbeing.

Mothers' well-being, parenting attitudes, and home environment: Cumulative risk and parity in early motherhood.

BACKGROUND: This study explores mothers' wellbeing, experiences, and attitudes and the impact of cumulative demographic and antenatal risks and parity on parenting outcomes. A secondary aim was to assess mother and infant service utilisation. METHOD: This study involved an assessment of the baseline characteristics of a sample of mothers (N = 190; Mean age = 31.6 years, SD = 5.4) with young infants (average age = 10.13 weeks, SD = 0.8) living in disadvantaged communities in Ireland. RESULTS: Mothers with more risk factors (e.g., lone and/or teenage parenthood, socioeconomic disadvantage, and low social support) reported significantly higher levels of depression and lower parental self-efficacy. Observations of the home environment indicated that at-risk parents engaged in less cognitive stimulation and lower levels of emotional support for their child. The impact of these risk factors differed for primiparous and multiparous mothers. CONCLUSIONS: At-risk mothers are more susceptible to mental health difficulties and poorer parenting outcomes during the transition to parenthood. This study also provides important comparative insights into experiences of primiparous and multiparous parents. These findings have important implications for practitioners and policy makers, particularly the provision of universal and proportionate supports to prevent and/or interrupt poor parent-child relationships and negative developmental outcomes.

Integrating research and system-wide practice in public health: lessons learnt from Better Start Bradford.

Many interventions that are delivered within public health services have little evidence of effect. Evaluating interventions that are being delivered as a part of usual practice offers opportunities to improve the evidence base of public health. However, such evaluation is challenging and requires the integration of research into system-wide practice. The Born in Bradford's Better Start experimental birth cohort offers an opportunity to efficiently evaluate multiple complex community interventions to improve the health, wellbeing and development of children aged 0-3 years. Based on the learning from this programme, this paper offers a pragmatic and practical guide to researchers, public health commissioners and service providers to enable them to integrate research into their everyday practice, thus enabling relevant and robust evaluations within a complex and changing system.Using the principles of co-production the key challenges of integrating research and practice were identified, and appropriate strategies to overcome these, developed across five key stages: 1) Community and stakeholder engagement; 2) Intervention design; 3) Optimising routinely collected data; 4) Monitoring implementation; and 5) Evaluation. As a result of our learning we have developed comprehensive toolkits ( https://borninbradford.nhs.uk/what-we-do/pregnancy-early-years/toolkit/ ) including: an operational guide through the service design process; an implementation and monitoring guide; and an evaluation framework. The evaluation framework incorporates implementation evaluations to enable understanding of intervention performance in practice, and quasi experimental approaches to infer causal effects in a timely manner. We also offer strategies to harness routinely collected data to enhance the efficiency and affordability of evaluations that are directly relevant to policy and practice.These strategies and tools will help researchers, commissioners and service providers to work together to evaluate interventions delivered in real-life settings. More importantly, however, we hope that they will support the development of a connected system that empowers practitioners and commissioners to embed innovation and improvement into their own practice, thus enabling them to learn, evaluate and improve their own services.

Statistical design and analysis in trials of proportionate interventions: a systematic review.

BACKGROUND: In proportionate or adaptive interventions, the dose or intensity can be adjusted based on individual need at predefined decision stages during the delivery of the intervention. The development of such interventions may require an evaluation of the effectiveness of the individual stages in addition to the whole intervention. However, evaluating individual stages of an intervention has various challenges, particularly the statistical design and analysis. This review aimed to identify the use of trials of proportionate interventions and how they are being designed and analysed in current practice. METHODS: We searched MEDLINE, Web of Science and PsycINFO for articles published between 2010 and 2015 inclusive. We considered trials of proportionate interventions in all fields of research. For each trial, its aims, design and analysis were extracted. The data synthesis was conducted using summary statistics and a narrative format. RESULTS: Our review identified 44 proportionate intervention trials, comprising 28 trial results, 13 protocols and three secondary analyses. These were mostly described as stepped care (n=37) and mainly focussed on mental health research (n=30). The other studies were aimed at finding an optimal adaptive treatment strategy (n=7) in a variety of therapeutic areas. Further terminology used included adaptive intervention, staged intervention, sequentially multiple assignment trial or a two-phase design. The median number of decision stages in the interventions was two and only one study explicitly evaluated the effect of the individual stages. CONCLUSIONS: Trials of proportionate staged interventions are being used predominantly within the mental health field. However, few studies consider the different stages of the interventions, either at the design or the analysis phase, and how they may interact with one another. There is a need for further guidance on the design, analyses and reporting across trials of proportionate interventions. TRIAL REGISTRATION: Prospero, CRD42016033781. Registered on 2 February 2016.