Exploring attitudes and variation by sociodemographic factors in consent provided for financial data linkage in an experimental birth cohort study.

BACKGROUND: Improving our understanding of household incomes and what constitutes financial insecurity can help us to better understand how financial insecurity is experienced and how this can change over time within and between individuals and populations. However, financial circumstances are often perceived as sensitive and stigmatising, particularly within some ethnic minority groups. This research aims to explore attitudes and variation by sociodemographic factors in consent provided for financial data linkage in an experimental birth cohort study, in order to obtain validated income and benefits data and to better understand the impact of community interventions on the financial security of its participants and their families. METHODS: This research utilises an observational study design to explore consent rates, attitudes and variation in sociodemographic factors between participants of an experimental birth cohort in a deprived and ethnically diverse setting who consent and do not consent to financial data linkage. RESULTS: Overall, participants were equally likely to consent and decline consent for financial data linkage. Measures of socioeconomic insecurity were associated with being more likely to provide consent for financial data linkage. Participants who were not employed (OR 1.49 95% CI 0.93, 2.40) and were more financially insecure (OR 1.85 95% CI 1.14, 3.93) were more likely to provide consent for financial data linkage. Where the participant's first language was a language other than English, participants were also less likely to provide consent for data linkage (OR 0.65 95% CI 0.39, 0.98). The choice of consent for financial data linkage was not associated with: ethnicity; relationship factors; employment status of the participant's partner; person present at time of recruitment; and measures of health, such as general health, mental health, wellbeing and health-related quality of life. CONCLUSIONS: This research sets out an approach to obtaining validated income and benefits data, as a proxy measure for financial security, within an experimental birth cohort study in a deprived and ethnically diverse setting. It achieves good consent rates and demonstrates greater input from those who report greater potential need for financial support. Further research should be conducted to further understand the interplay of language spoken in this context.

Exploring the feasibility of evaluating a community alliance welfare advice programme co-located in primary care in Bradford: an uncontrolled before and after study.

BACKGROUND: Welfare advice services co-located in health settings are known to improve financial security. However, little is known on how to effectively evaluate these services. This study aims to explore the feasibility of evaluating a welfare advice service co-located in a primary care setting in a deprived and ethnically diverse population. It seeks to investigate whether the proposed evaluation tools and processes are acceptable and feasible to implement and whether they are able to detect any evidence of promise for this intervention on the mental health, wellbeing and financial security of participants. METHODS: An uncontrolled before and after study design was utilised. Data on mental health, wellbeing, quality of life and financial outcomes were collected at baseline prior to receiving welfare advice and at three months follow-up. Multiple logistic and linear regression models were used to explore individual differences in self-reported financial security and changes to mental health, wellbeing and quality of life scores before and after the provision of welfare advice. RESULTS: Overall, the majority of key outcome measures were well completed, indicating participant acceptability of the mental health, wellbeing, quality of life and financial outcome measures used in this population. There was evidence suggestive of an improvement in participant financial security and evidence of promise for improvements in measured wellbeing and health-related quality of life for participants accessing services in a highly ethnically diverse population. Overall, the VCS Alliance welfare advice programme generated a total of £21,823.05 for all participants, with participants gaining an average of £389.70 per participant for participants with complete financial outcome data. CONCLUSIONS: This research demonstrates the feasibility of evaluating a welfare advice service co-located in primary care in a deprived and ethnically diverse setting utilising the ascribed mental health, wellbeing and quality of life and financial outcome tools. It provides evidence of promise to support the hypothesis that the implementation of a welfare advice service co-located in a health setting can improve health and wellbeing and reduce health inequalities.

Applying the community readiness model to identify and address inequity in end-of-life care in South Asian communities.

BACKGROUND: Individuals from minoritised ethnic backgrounds are less likely than individuals from the dominant ethnic group to access palliative care services and to have documented Advance Care Plans. They are more likely to be admitted to hospital in the last months of life. AIM: To use the Community Readiness Model to identify the barriers that influence how South Asian communities access and use two new palliative care services. DESIGN: The Community Readiness Model is a validated tool that measures the readiness of a community. Key stakeholders were asked to: (i) complete a questionnaire to assess South Asian communities' readiness to engage in advance care planning and, (ii) attend a focus group to explore their views on the communities' understandings of palliative and end-of-life care. SETTING/PARTICIPANTS: Ten key stakeholders who held a variety of occupations within palliative and end-of-life care services were recruited from the community. FINDINGS: The South Asian communities were found to be at the 'pre-planning' stage of readiness, despite initiatives to improve awareness. The readiness of the health system was found to be limited, with a narrow medical focus during advance care planning, poor integration of voluntary and community services and limited understanding of what people consider a 'good' death. CONCLUSIONS: The Community Readiness Model allowed insight into the South Asian communities' awareness of and readiness (to use) palliative care services. Using the Community Readiness Model before service implementation allowed steps to be taken to avoid widening inequities in access and use of new services.

Being pregnant and becoming a parent during the COVID-19 pandemic: a longitudinal qualitative study with women in the Born in Bradford COVID-19 research study.

BACKGROUND: Uncertainty around the risk of COVID-19 to pregnant women and their babies prompted precautionary restrictions on their health and care during the pandemic. Maternity services had to adapt to changing Government guidance. Coupled with the imposition of national lockdowns in England and restrictions on daily activities, women's experiences of pregnancy, childbirth and the postpartum period, and their access to services, changed rapidly. This study was designed to understand women's experiences of pregnancy, labour and childbirth and caring for a baby during this time. METHODS: This was an inductive longitudinal qualitative study, using in-depth interviews by telephone with women in Bradford, UK, at three timepoints during their maternity journey (18 women at timepoint one, 13 at timepoint two and 14 at timepoint three). Key topics explored were physical and mental wellbeing, experience of healthcare services, relationships with partners and general impact of the pandemic. Data were analysed using the Framework approach. A longitudinal synthesis identified over-arching themes. RESULTS: Three longitudinal themes captured what was important to women: (1) women feared being alone at critical points in their maternity journey, (2) the pandemic created new norms for maternity services and women's care, and (3) finding ways to navigate the COVID-19 pandemic in pregnancy and with a baby. CONCLUSIONS: Modifications to maternity services impacted significantly on women's experiences. The findings have informed national and local decisions about how best to direct resources to reduce the impact of COVID-19 restrictions and the longer-term psychological impact on women during pregnancy and postnatally.

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).

Covid-19 lockdown: Ethnic differences in children's self-reported physical activity and the importance of leaving the home environment; a longitudinal and cross-sectional study from the Born in Bradford birth cohort study.

BACKGROUND: In England, the onset of COVID-19 and a rapidly increasing infection rate resulted in a lockdown (March-June 2020) which placed strict restrictions on movement of the public, including children. Using data collected from children living in a multi-ethnic city with high levels of deprivation, this study aimed to: (1) report children's self-reported physical activity (PA) during the first COVID-19 UK lockdown and identify associated factors; (2) examine changes of children's self-reported PA prior to and during the first UK lockdown. METHODS: This study is part of the Born in Bradford (BiB) COVID-19 Research Study. PA (amended Youth Activity Profile), sleep, sedentary behaviours, daily frequency/time/destination/activity when leaving the home, were self-reported by 949 children (9-13 years). A sub-sample (n = 634) also self-reported PA (Physical Activity Questionnaire for Children) pre-pandemic (2017-February 2020). Univariate analysis assessed differences in PA between sex and ethnicity groups; multivariable logistic regression identified factors associated with children's PA. Differences in children's levels of being sufficiently active prior to and during the lockdown were examined using the McNemar test; and multivariable logistic regression was used to identify factors explaining change. RESULTS: During the pandemic, White British (WB) children were more sufficiently active (34.1%) compared to Pakistani Heritage children (PH) (22.8%) or 'Other' ethnicity children (O) (22.8%). WB children reported leaving the home more frequently and for longer periods than PH and O children. Modifiable variables related to being sufficiently active were frequency, duration, type of activity, and destination away from the home environment. There was a large reduction in children being sufficiently active during the first COVID-19 lockdown (28.9%) compared to pre-pandemic (69.4%). CONCLUSIONS: Promoting safe extended periods of PA everyday outdoors is important for all children, in particular for children from ethnic minority groups. Children's PA during the first COVID-19 UK lockdown has drastically reduced from before. Policy and decision makers, and practitioners should consider the findings in order to begin to understand the impact and consequences that COVID-19 has had upon children's PA which is a key and vital behaviour for health and development.

Understanding COVID-19 misinformation and vaccine hesitancy in context: Findings from a qualitative study involving citizens in Bradford, UK.

BACKGROUND: COVID-19 vaccines can offer a route out of the pandemic, yet initial research suggests that many are unwilling to be vaccinated. A rise in the spread of misinformation is thought to have played a significant role in vaccine hesitancy. To maximize uptake, it is important to understand why misinformation has been able to take hold at this time and why it may pose a more significant problem within certain contexts. OBJECTIVE: To understand people's COVID-19 beliefs, their interactions with (mis)information during COVID-19 and attitudes towards a COVID-19 vaccine. DESIGN AND PARTICIPANTS: Bradford, UK, was chosen as the study site to provide evidence to local decision makers. In-depth phone interviews were carried out with 20 people from different ethnic groups and areas of Bradford during Autumn 2020. Reflexive thematic analysis was conducted. RESULTS: Participants discussed a wide range of COVID-19 misinformation they had encountered, resulting in confusion, distress and mistrust. Vaccine hesitancy could be attributed to three prominent factors: safety concerns, negative stories and personal knowledge. The more confused, distressed and mistrusting participants felt about their social worlds during the pandemic, the less positive they were about a vaccine. CONCLUSIONS: COVID-19 vaccine hesitancy needs to be understood in the context of the relationship between the spread of misinformation and associated emotional reactions. Vaccine programmes should provide a focused, localized and empathetic response to counter misinformation. PATIENT OR PUBLIC CONTRIBUTION: A rapid community and stakeholder engagement process was undertaken to identify COVID-19 priority topics important to Bradford citizens and decision makers.

Assessing community readiness for early intervention programmes to promote social and emotional health in children.

OBJECTIVE: Evidence for early intervention and prevention-based approaches for improving social and emotional health in young children is robust. However, rates of participation in programmes are low. We explored the dynamics which affect levels of community readiness to address the issues of social and emotional health for pregnant women, young children (0-4 years) and their mothers. SETTING: A deprived inner-city housing estate in the north of England. The estate falls within the catchment area of a project that has been awarded long-term funding to address social and emotional health during pregnancy and early childhood. METHODS: We interviewed key respondents using the Community Readiness Model. This approach applies a mixed methodology, incorporating readiness scores and qualitative data. A mean community readiness score was calculated enabling the placement of the community in one of nine possible stages of readiness. Interview transcripts were analysed using a qualitative framework approach to generate contextual information to augment the numerical scores. RESULTS: An overall score consistent with vague awareness was achieved, indicating a low level of community readiness for social and emotional health interventions. This score suggests that there will be a low likelihood of participation in programmes that address these issues. CONCLUSION: Gauging community readiness offers a way of predicting how willing and prepared a community is to address an issue. Modifying implementation plans so that they first address community readiness may improve participation rates.

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.

Disciplinary power and the process of training informal carers on stroke units.

This article examines the process of training informal carers on stroke units using the lens of power. Care is usually assumed as a kinship obligation but the state has long had an interest in framing the carer and caring work. Training carers in healthcare settings raises questions about the power of the state and healthcare professionals as its agents to shape expectations and practices related to the caring role. Drawing on Foucault's notion of disciplinary power, we show how disciplinary forms of power exercised in interactions between healthcare professionals and carers shape the engagement and resistance of carers in the process of training. Interview and observational field note extracts are drawn from a multi-sited study of a training programme on stroke units targeting family carers of people with stroke to consider the consequences of subjecting caring to this intervention. We found that the process of training informal carers on stroke units was not simply a matter of transferring skills from professional to lay person, but entailed disciplinary forms of power intended to shape the conduct of the carer. We interrogate the extent to which a specific kind of carer is produced through such an approach, and the wider implications for the participation of carers in training in healthcare settings and the empowerment of carers.

Born in Bradford's Better Start: an experimental birth cohort study to evaluate the impact of early life interventions.

BACKGROUND: Early interventions are recognised as key to improving life chances for children and reducing inequalities in health and well-being, however there is a paucity of high quality research into the effectiveness of interventions to address childhood health and development outcomes. Planning and implementing standalone RCTs for multiple, individual interventions would be slow, cumbersome and expensive. This paper describes the protocol for an innovative experimental birth cohort: Born in Bradford's Better Start (BiBBS) that will simultaneously evaluate the impact of multiple early life interventions using efficient study designs. Better Start Bradford (BSB) has been allocated £49 million from the Big Lottery Fund to implement 22 interventions to improve outcomes for children aged 0-3 in three key areas: social and emotional development; communication and language development; and nutrition and obesity. The interventions will be implemented in three deprived and ethnically diverse inner city areas of Bradford. METHOD: The BiBBS study aims to recruit 5000 babies, their mothers and their mothers' partners over 5 years from January 2016-December 2020. Demographic and socioeconomic information, physical and mental health, lifestyle factors and biological samples will be collected during pregnancy. Parents and children will be linked to their routine health and local authority (including education) data throughout the children's lives. Their participation in BSB interventions will also be tracked. BiBBS will test interventions using the Trials within Cohorts (TwiCs) approach and other quasi-experimental designs where TwiCs are neither feasible nor ethical, to evaluate these early life interventions. The effects of single interventions, and the cumulative effects of stacked (multiple) interventions on health and social outcomes during the critical early years will be measured. DISCUSSION: The focus of the BiBBS cohort is on intervention impact rather than observation. As far as we are aware BiBBS is the world's first such experimental birth cohort study. While some risk factors for adverse health and social outcomes are increasingly well described, the solutions to tackling them remain elusive. The novel design of BiBBS can contribute much needed evidence to inform policy makers and practitioners about effective approaches to improve health and well-being for future generations.

The development and implementation of the structured training programme for caregivers of inpatients after stroke (TRACS) intervention: the London Stroke Carers Training Course.

OBJECTIVE: To describe the content and delivery of the adapted London Stroke Carers Training Course intervention evaluated in the Training Caregivers after Stroke (TRACS) trial. SETTING: The London Stroke Carers Training Course is a structured training programme for caregivers of inpatients who are likely to return home after their stroke. The course was delivered by members of the multidisciplinary team while the patient was in the stroke unit with one recommended 'follow through' session after discharge home. INTERVENTION: The intervention consists of 14 training components (six mandatory) that were identified as important knowledge/skills that caregivers would need to be able to care for the stroke patient after discharge home. Following national training days, the London Stroke Carers Training Course was disseminated to intervention sites by the cascade method of implementation. RESULTS: The intervention was adapted for implementation across a range of stroke units. Training days were well attended (median 2.5 and 2.0 attendees per centre for the first and second days, respectively) and the feedback positive, demonstrating 'face validity' for the intervention. However cascading of this training to other members of the multidisciplinary team was not consistent, with 7/18 centres recording no cascade training. CONCLUSION: The adapted London Stroke Carers Training Course provided a training programme that could be delivered in a standardised, structured way in a variety of stroke unit settings throughout the UK. The intervention was well received by stroke unit staff, however, the cascade method of implementation was not as effective as we would have wished.

A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis.

BACKGROUND: Most patients who have had a stroke are dependent on informal caregivers for activities of daily living. The TRACS trial investigated a training programme for caregivers (the London Stroke Carers Training Course, LSCTC) on physical and psychological outcomes, including cost-effectiveness, for patients and caregivers after a disabling stroke. METHODS: We undertook a pragmatic, multicentre, cluster randomised controlled trial with a parallel cost-effectiveness analysis. Stroke units were eligible if four of five criteria used to define a stroke unit were met, a substantial number of patients on the unit had a diagnosis of stroke, staff were able to deliver the LSCTC, and most patients were discharged to a permanent place of residence. Stroke units were randomly assigned to either LSCTC or usual care (control group), stratified by geographical region and quality of care, and using blocks of size 2. Patients with a diagnosis of stroke, likely to return home with residual disability and with a caregiver providing support were eligible. The primary outcome for patients was self-reported extended activities of daily living at 6 months, measured with the Nottingham Extended Activities of Daily Living (NEADL) scale. The primary outcome for caregivers was self-reported burden at 6 months, measured with the caregivers burden scale (CBS). We combined patient and caregiver costs with primary outcomes and quality-adjusted life-years (QALYs) to assess cost-effectiveness. This trial is registered with controlled-trials.com, number ISRCTN 49208824. FINDINGS: We assessed 49 stroke units for eligibility, of which 36 were randomly assigned to either the intervention group or the control group. Between Feb 27, 2008, and Feb 9, 2010, 928 patient and caregiver dyads were registered, of which 450 were in the intervention group, and 478 in the control group. Patients' self-reported extended activities of daily living did not differ between groups at 6 months (adjusted mean NEADL score 27·4 in the intervention group versus 27·6 in the control group, difference -0·2 points [95% CI -3·0 to 2·5], p value=0·866, ICC=0·027). The caregiver burden scale did not differ between groups either (adjusted mean CBS 45·5 in the intervention group versus 45·0 in the control group, difference 0·5 points [95% CI -1·7 to 2·7], p value=0·660, ICC=0·013). Patient and caregiver costs were similar in both groups (length of the initial stroke admission and associated costs were £13,127 for the intervention group and £12,471 for the control group; adjusted mean difference £1243 [95% CI -1533 to 4019]; p value=0·380). Probabilities of cost-effectiveness based on QALYs were low. INTERPRETATION: In a large scale, robust evaluation, results from this study have shown no differences between the LSCTC and usual care on any of the assessed outcomes. The immediate period after stroke might not be the ideal time to deliver structured caregiver training. FUNDING: Medical Research Council.

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.

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.

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).

Children's behavioural and emotional wellbeing during the COVID-19 pandemic: Findings from the Born in Bradford COVID-19 mixed methods longitudinal study.

Background: The COVID-19 pandemic led to a multitude of immediate social restrictions for many across the world. In the UK, the lives of children and young people were quickly impacted when COVID-19 restrictions led to school closures for most children and restrictions on social interactions. The Born in Bradford COVID-19 longitudinal research study explored the impact of the COVID-19 pandemic on the lives of children and their families living in Bradford. Methods: Surveys were administered during the first wave of the pandemic (March to June 2020) and compared to findings from before the pandemic. The current study examined the social and emotional wellbeing of children from before to during the pandemic, measured using the parent completed Strengths and Difficulties questionnaire (SDQ). Regression analyses looked at associations between a range of social determinants of health and changes in SDQ scores. Results: The results showed that those children most likely to experience difficulties during the pandemic were boys, younger children, those from White British ethnicity (compared to Pakistani heritage children) and those living in the most deprived areas. There were associations between experiencing difficulties and: food insecurity; financial worry; getting below recommended levels of physical activity; and having less than the recommended amount of sleep. Conclusions: The effect of COVID-19 restrictions are likely to have had negative consequences on children that could, in time, have long-lasting impacts on the health, wellbeing and development of children in the UK.

The COVID-19 pandemic caused immediate and long-lasting social restrictions to be implemented here in the UK and across the world. In the UK, children and young people were quickly affected by these restrictions that led to school closures and other restrictions that prevented these individuals from socialising in person with one another. This study explored the impact that the pandemic had on the wellbeing of children by comparing data from before the pandemic with data collected during the pandemic. The data that has been collected looks at the behavioural strengths and difficulties that children are displaying. Our exploration found that children that were most likely to experience difficulties during the pandemic were boys, younger children, those who were White British and those who lived in the most deprived areas. The effect of the COVID-19 restrictions are likely to have had a negative impact on children and young people which in time may impact the health and development of children living here in the UK.

Born in Bradford's Age of Wonder cohort: protocol for adolescent data collection.

Background: Adolescence and transition into adulthood are periods shaping life-long mental health, cardiometabolic risk, and inequalities. However, they are poorly studied and understood. By extending and expanding the Born in Bradford (BiB) cohort study through this period using innovative, co-produced approaches to collect and analyse data, we aim to understand better the interplay of factors that influence health and wellbeing, and inform/evaluate interventions to improve them and reduce inequalities. Protocol: BiB Age of Wonder (AoW) is a large, whole city cohort that will capture the contemporary lived experience amongst multi-ethnic adolescents progressing into young adulthood. We will collect repeated data from existing BiB participants and their peers (N~30,000 adolescents). The protocol for the first phase of the quantitative methods, involving survey measurements and health assessments in mainstream secondary schools is described here. We describe the co-production behind these methods, and lessons learned from the first year of data collection.

Born in Bradford have been following the health and wellbeing of over 13,000 Bradford children since they were born. This group of children are now in their teenage years ­ a time that is crucial for their future mental and physical health. Age of Wonder aims to capture this journey through adolescence and early adulthood with up to 30,000 young people in Bradford over 7 years. In the first phase of this project, data collection is taking part in secondary schools in Bradford. This protocol describes how this data collection is currently being carried out in the schools. Young people aged 12-15 are being asked to complete questionnaires, covering topics such as mental and physical health. These topics have been designed with groups of young people, schools and other partners, to make sure we are capturing data on the things most important to young people. Those in Year 9 (13-14 years old), are also asked to take part in physical health measurements such as height, weight, blood pressure and a blood sample, as well as computer-based assessments of cognition (memory), movement and language. There have been a number of lessons learned from the first full year of data collection, such as how to make the research as easy as possible for schools to take part in when they have so many competing demands on their time.

"We lost a lot, but something good came out of it too:" Exploring the impact of the COVID-19 pandemic on the mental wellbeing of British Muslim Pakistani women with family responsibilities.

BACKGROUND: The COVID-19 pandemic and associated restrictions caused major disruption globally, shedding light on the unprecedented strain upon the mental health and wellbeing of individuals around the world. Poor mental health in the pandemic is reported to be greater in women, with mothers being at increased risk. It is unclear whether there are differences in the impact of mental wellbeing on some ethnic groups over others. The aim of this study was to explore the experiences of British Muslim Pakistani women with family responsibilities during the COVID-19 pandemic, two years on from the first lockdown. METHODS: Qualitative interviews with women were conducted via telephone using a semi-structured topic guide. The sample included 25 British Muslim Pakistani women with family responsibilities, both English and non-English speaking. Women lived in households that ranged in number and included extended family. Key themes were determined using thematic analysis. RESULTS: Results were grouped under three themes. These were (1) Community, cultural and religious contributors to poor mental wellbeing, (2) religious and cultural mediators of mental distress, and (3) perceived positive impact on lifestyle. British Muslim Pakistani women were psychologically distressed by the high rates of virus transmission and deaths in their communities and at the prospect of older members of their extended family developing the virus. The impact of restrictions on fundamental religious and cultural interactions further exacerbated poor mental wellbeing in this population. Religion, community social capital and larger household structures were all effective coping strategies for British Muslim Pakistani women. Positive impacts of the pandemic included becoming closer to family and faith, and increased work/life harmony. CONCLUSIONS: An exploration of religious and cultural coping mechanisms should be used to inform future national pandemic preparedness plans, as well as effective strategies for building and maintaining social capital. This may increase adherence to physical distancing and other protective behaviours in populations.

Risk factors for early language delay in children within a minority ethnic, bilingual, deprived environment (Born in Bradford's Better Start): a UK community birth cohort study.

BACKGROUND: Preschool language skills and language delay predict academic and socioemotional outcomes. Children from deprived environments are at a higher risk of language delay, and both minority ethnic and bilingual children can experience a gap in language skills at school entry. However, research that examines late talking (preschool language delay) in an ethnically diverse, bilingual, deprived environment at age 2 is scarce. METHODS: Data from Born in Bradford's Better Start birth cohort were used to identify rates of late talking (≤10th percentile on the Oxford-Communicative Development Inventory: Short) in 2-year-old children within an ethnically diverse, predominantly bilingual, deprived UK region (N=712). The relations between known demographic, maternal, distal and proximal child risk factors, and language skills and language delay were tested using hierarchical linear and logistic regression. RESULTS: A total of 24.86% of children were classified as late talkers. Maternal demographic factors (ethnicity, born in UK, education, financial security, employment, household size, age) predicted 3.12% of the variance in children's expressive vocabulary. Adding maternal language factors (maternal native language, home languages) and perinatal factors (birth weight, gestation) to the model predicted 3.76% of the variance. Adding distal child factors (child sex, child age) predicted 11.06%, and adding proximal child factors (receptive vocabulary, hearing concerns) predicted 49.51%. Significant risk factors for late talking were male sex (OR 2.07, 95% CI 1.38 to 3.09), receptive vocabulary delay (OR 8.40, 95% CI 4.99 to 14.11) and parent-reported hearing concerns (OR 7.85, 95% CI 1.90 to 32.47). Protective factors were increased household size (OR 0.85, 95% CI 0.77 to 0.95) and age (OR 0.82, 95% CI 0.70 to 0.96). CONCLUSIONS: Almost one in four children living in an ethnically diverse and deprived UK area have early language delay. Demographic factors explained little variance in early vocabulary, whereas proximal child factors held more predictive value. The results indicate further research on early language delay is warranted for vulnerable groups.