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).

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.

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.

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

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

Psychological interventions for epilepsy: How good are trialists at assessing their implementation fidelity, what are the barriers, and what are journals doing to encourage it? A mixed methods study.

INTRODUCTION: Psychological interventions hold promise for the epilepsy population and continue to be trialed to determine their efficacy. Such interventions present opportunities for variance in delivery. Therefore, to accurately interpret a trial's estimate of effect, information on implementation fidelity (IF) is required. We present a novel 3-part study. Part 1 systematically rated trials for the extent to which they reported assessing whether the intervention was delivered as intended (adherence) and with what sort of skill (competence). Part 2 identified barriers to reporting and assessing on fidelity perceived by trialists. Part 3 determined what journals publishing epilepsy trials are doing to support IFs reporting. METHODS: Articles for 50 randomized controlled trials (RCTs)/quasi-RCTs of psychological interventions identified by Cochrane searches were rated using the Psychotherapy Outcome Study Methodology Rating Form's fidelity items. The 45 corresponding authors for the 50 trials were invited to complete the 'Barriers to Treatment Integrity Implementation Survey'. 'Instructions to Authors' for the 17 journals publishing the trials were reviewed for endorsement of popular reporting guidelines which refer to fidelity (Consolidated Standards of Reporting Trials (CONSORT) statement or Journal Article Reporting Standards [JARS]) and asked how they enforced compliance. RESULTS: Part 1: 15 (30%) trials reported assessing for adherence, but only 2 (4.3%) gave the result. Four (8.5%) reported assessing for competence, 1 (2.1%) gave the result. Part 2: 22 trialists - mostly chief investigators - responded. They identified 'lack of theory and specific guidelines on treatment integrity procedures', 'time, cost, and labor demands', and 'lack of editorial requirement' as "strong barriers". Part 3: Most (15, 88.2%) journals endorsed CONSORT or JARS, but only 5 enforced compliance. CONCLUSIONS: Most trials of psychological interventions for epilepsy are not reported in a transparent way when it comes to IF. The barriers' trialists identify for this do not appear insurmountable. Addressing them could ultimately help the field to better understand how best to support the population with epilepsy.

Can we identify the prevalence of perinatal mental health using routinely collected health data?: A review of publicly available perinatal mental health data sources in England.

Introduction: Perinatal mental health (PMH) conditions affect around one in four women, and may be even higher in women from some ethnic minority groups and those living in low socioeconomic circumstances. Poor PMH causes significant distress and can have lifelong adverse impacts for some children. In England, current prevalence rates are estimated using mental health data of the general population and do not take sociodemographic variance of geographical areas into account. Services cannot plan their capacity and ensure appropriate and timely support using these estimates. Our aim was to see if PMH prevalence rates could be identified using existing publicly available sources of routine health data. Methods: A review of data sources was completed by searching NHS Digital (now NHS England), Public Health England and other national PMH resources, performing keyword searches online, and research team knowledge of the field. The sources were screened for routine data that could be used to produce prevalence of PMH conditions by sociodemographic variation. Included sources were reviewed for their utility in accessibility, data relevance and technical specification relating to PMH and sociodemographic data items. Results: We found a PMH data 'blind spot' with significant inadequacies in the utility of all identified data sources, making it impossible to provide information on the prevalence of PMH in England and understand variation by sociodemographic differences. Conclusions: To enhance the utility of publicly available routine data to provide PMH prevalence rates requires improved mandatory PMH data capture in universal services, available publicly via one platform and including assessment outcomes and sociodemographic data.

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).

Study protocol for a systems evaluation of an infant mental health service: Integration of 'Little Minds Matter' into the early years system.

Infant Mental Health relates to how well a child develops socially and emotionally from birth to age three. There is a well-established link between parent-infant relationship quality, Infant Mental Health, and longer-term social and emotional development there is a lack of evidence-based interventions that support the parent-infant relationship and/or protect against poor Infant Mental Health. Little Minds Matter is a specialist Infant Mental Health service developed in Bradford (UK) to support parent-infant relationships by providing training and consultation for professionals and direct clinical work to families. The successful implementation of this intervention depends upon how well it becomes embedded within, or integrated into, the early years system. For the purposes of this study, the early years system includes health, social and education services that support child health and development from conception to primary school entry at age five. This study protocol aims to apply a systems approach to evaluate this service and provide a perspective on the process of embedding a complex service within a healthcare system. Multiple methods will be used to investigate embeddedness within the wider early years system. Routinely collected quantitative data about the service will be used to develop a system map showing interaction with related services. Qualitative data will be collected at two time points through interviews with individuals involved in the design and provision of the service, and professionals working within the early years system. Framework analysis will be used to analyse the data inductively and deductively within a systems approach. The findings from this study will provide evidence to inform the ongoing implementation of the service for providers and commissioning bodies. Exploring the application of a systems approach in this clinical context will have application more broadly for researchers evaluating complex interventions and services within a wider system.

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.

Risk of Developmental Disorders in Children Born at 32 to 38 Weeks' Gestation: A Meta-Analysis.

CONTEXT: Very preterm birth (<32 weeks) is associated with increased risk of developmental disorders. Emerging evidence suggests children born 32 to 38 weeks might also be at risk. OBJECTIVES: To determine the relative risk and prevalence of being diagnosed with, or screening positive for, developmental disorders in children born moderately preterm, late preterm, and early term compared with term (≥37 weeks) or full term (39-40/41 weeks). DATA SOURCES: Medline, Embase, Psychinfo, Cumulative Index of Nursing, and Allied Health Literature. STUDY SELECTION: Reported ≥1 developmental disorder, provided estimates for children born 32 to 38 weeks. DATA EXTRACTION: A single reviewer extracted data; a 20% sample was second checked. Data were pooled using random-effects meta-analyses. RESULTS: Seventy six studies were included. Compared with term born children, there was increased risk of most developmental disorders, particularly in the moderately preterm group, but also in late preterm and early term groups: the relative risk of cerebral palsy was, for 32 to 33 weeks: 14.1 (95% confidence intervals [CI]: 12.3-16.0), 34 to 36 weeks: 3.52 (95% CI: 3.16-3.92) and 37 to 38 weeks: 1.44 (95% CI: 1.32-1.58). LIMITATIONS: Studies assessed children at different ages using varied criteria. The majority were from economically developed countries. All were published in English. Data were variably sparse; subgroup comparisons were sometimes based on single studies. CONCLUSIONS: Children born moderately preterm are at increased risk of being diagnosed with or screening positive for developmental disorders compared with term born children. This association is also demonstrated in late preterm and early term groups but effect sizes are smaller.

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.

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.

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.

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.

Addressing inequalities in the identification and management of perinatal mental health difficulties: The perspectives of minoritised women, healthcare practitioners and the voluntary sector.

Background: Perinatal mental health (PMH) difficulties affect approximately one in five birthing women. If not identified and managed appropriately, these PMH difficulties can carry impacts across generations, affecting mental health and relationship outcomes. There are known inequalities in identification and management across the healthcare pathway. Whilst barriers and facilitators have been identified there is a lack of clarity about how these relate to the avoidable and unfair inequalities experienced by various groups of women. Further research is required to understand how to address inequalities in PMH. Aim: To understand the key factors that enable and hinder access to PMH care for women from minoritised groups across the PMH care pathway, and how these have been affected by the COVID-19 pandemic. Methods: A sequential mixed-methods approach gathered views and experiences from stakeholders in one region in northern England. This included an online survey with 145 NHS healthcare practitioners and semi-structured interviews with 19 women from ethnic minority and/or socio-economically deprived backgrounds who had experienced PMH difficulties, and 12 key informants from the voluntary and community sector workforce. Quantitative data were analysed using descriptive statistics and framework analysis was applied to qualitative data. Findings: Barriers and facilitators were mapped using a socio-technical framework to understand the role of (i) processes, (ii) people (organised as women, practitioners and others), (iii) technology, and (iv) the system as a whole in deepening or alleviating inequalities. Influences that were identified as pertinent to inequalities in identification and management included provision of interpreters, digital exclusion, stigma, disempowerment, distrust of services, practitioner attitudes, data capture, representation in the workforce, narrow rules of engagement and partnership working. Stakeholder groups expressed that several barriers were further compounded by the COVID-19 pandemic. Discussion: The findings highlight the need for change at the system level to tackle inequalities across the PMH care pathway. Four inter-connected recommendations were developed to enable this systems change: building emotional safety between professionals and women; making PMH a part of core healthcare business; increasing cultural competency specific to PMH; and enhanced partnership working.

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.

Born in Bradford's Better Start (BiBBS) interventional birth cohort study: Interim cohort profile.

Background: The Born in Bradford's Better Start (BiBBS) interventional birth cohort study was designed as an innovative cohort platform for efficient evaluation of early life interventions delivered through the Better Start Bradford programme. There are a growing number of interventional cohorts being implemented internationally. This paper provides an interim analysis of BiBBS in order to share learning about the feasibility and value of this method. Methods: Recruitment began in January 2016 and will complete in December 2023 with a target sample of 5,000 pregnancies. An interim analysis was completed for all pregnancies recruited between January 2016 and November 2019 with an expected due date between 1 st April 2016 and 8 th March 2020. Descriptive statistics were completed on the data. Results: Of 4,823 eligible pregnancies, 2,626 (54%) pregnancies were recruited, resulting in 2,392 mothers and 2,501 children. The sample are representative of the pregnant population (61% Pakistani heritage; 12% White British; 8% other South Asian and 6% Central and Eastern European ethnicity). The majority of participants (84%) live in the lowest decile of the Index of Multiple Deprivation, and many live in vulnerable circumstances. A high proportion (85%) of BiBBS families have engaged in one or more of the Better Start Bradford interventions. Levels of participation varied by the characteristics of the interventions, such as the requirement for active participation and the length of commitment to a programme. Conclusions: We have demonstrated the feasibility of recruiting an interventional cohort that includes seldom heard families from ethnic minority and deprived backgrounds. The high level of uptake of interventions is encouraging for the goal of evaluating the process and outcomes of multiple early life interventions using the innovative interventional cohort approach. BiBBS covers a period before, during and after the coronavirus disease 2019 (COVID-19) pandemic which adds scientific value to the cohort.

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.

Children and young people's concerns and needs relating to their use of health technology to self-manage long-term conditions: a scoping review.

BACKGROUND: The use of patient-facing health technologies to manage long-term conditions is increasing; however, children and young people may have particular concerns or needs before deciding to use different health technologies. AIMS: To identify children and young people's reported concerns or needs in relation to using health technologies to self-manage long-term conditions. METHODS: A scoping review was conducted. We searched MEDLINE, PsycINFO and CINAHL in February 2019. Searches were limited to papers published between January 2008 and February 2019. We included any health technology used to manage long-term conditions. A thematic synthesis of the data from the included studies was undertaken. We engaged children with long-term conditions (and parents) to support review design, interpretation of findings and development of recommendations. RESULTS: Thirty-eight journal articles were included, describing concerns or needs expressed by n=970 children and/or young people aged 5-18 years. Most included studies were undertaken in high-income countries with children aged 11 years and older. Studies examined concerns with mobile applications (n=14), internet (n=9), social media (n=3), interactive online treatment programmes (n=3), telehealth (n=1), devices (n=3) or a combination (n=5). Children and young people's main concerns were labelling and identity; accessibility; privacy and reliability; and trustworthiness of information. DISCUSSION: This review highlights important concerns that children and young people may have before using technology to self-manage their long-term condition. In future, research should involve children and young people throughout the development of technology, from identifying their unmet needs through to design and evaluation of interventions.