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IntroductionWomen 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 analysisAn 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 disseminationEthical 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

ObjectiveThis study aimed to examine profiles of co-occurrence of developmental disorders and their association with birth before full term.DesignLatent class analysis of cohort data with linked health data.SettingBradford, England.Patients13 172 children were included in the analysis.Outcome measuresDevelopmental disorder in medical records.MethodsData were censored at each child’s 12th birthday. The latent class analysis identified patterns of developmental disorders. Multinomial logistic regression explored the association with gestational age while adjusting for clinical and socio-factors.ResultsThe majority (12,536) had a low risk of developmental disorders; this group was named ‘typical development’. The remaining children were classified into three groups: ‘educational difficulties’ (347 children); ‘social, emotional, behavioural and communication difficulties’ (189 children) and ‘early developmental impairment, with physical and intellectual disabilities’ (100 children).Compared with ‘typical development’, very preterm birth was associated with an increased likelihood of being in the ‘early developmental impairment, with physical and intellectual disabilities’ group, adjusted relative risk ratio (aRRR): 9.22 (95% CI 4.58 to 18.55). Birth before full term was associated with increased likelihood of being in the ‘educational difficulties’ group; risk was highest <34 weeks (aRRR: 2.64 (95% CI 1.44 to 4.83)) but persisted up to 37–38 weeks: aRRR: 1.41 (95% CI 1.10 to 1.81). There was no association between gestational age and the ‘social, emotional, behavioural and communication difficulties’’ group.ConclusionFour distinct profiles of developmental disorders were identified; gestational age was associated with two of these. Understanding which disorders children are most at risk of and how these co-occur can help provide accurate information to families and contribute to prompt diagnosis.

IntroductionBehavioural and mental disorders have become a public health crisis and by 2020 may surpass physical illness as a major cause of disability. Early prevention is key. Two Incredible Years (IY) parent programmes that aim to enhance child well-being and development, IY Infant and IY Toddler, will be delivered and evaluated in a proportionate universal intervention model called Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE) Steps. The main research question is: Does E-SEE Steps enhance child social emotional well-being at 20 months when compared with services as usual?Methods and analysisE-SEE Steps will be delivered in community settings by Early Years Children’s Services and/or Public Health staff across local authorities. Parents of children aged 8 weeks or less, identified by health visitors, children’s centre staff or self-referral, are eligible for participation in the trial. The randomisation allocation ratio is 5:1 (intervention to control). All intervention parents will receive an Incredible Years Infant book (universal level), and may be offered the Infant and/or Toddler group-based programme/s—based on parent depression scores on the Patient Health Questionnaire or child social emotional well-being scores on the Ages and Stages Questionnaire: Social Emotional, Second Edition (ASQ:SE-2). Control group parents will receive services as usual. A process and economic evaluation are included. The primary outcome for the study is social emotional well-being, assessed at 20 months, using the ASQ:SE-2. Intention-to-treat and per protocol analyses will be conducted. Clustering and hierarchical effects will be accounted for using linear mixed models.Ethics and disseminationEthical approvals have been obtained from the University of York Education Ethics Committee (ref: FC15/03, 10 August 2015) and UK NHS REC 5 (ref: 15/WA/0178, 22 May 2015. The current protocol is Version 9, 26 February 2018. The sponsor of the trial is the University of York. Dissemination of findings will be via peer-reviewed journals, conference presentations and public events.Trial registration number ISRCTN11079129; Pre-results.

Early years interventions, particularly those supporting parents in the first 1001 days of their infants life, support healthy development of infants and prevent adverse experiences that can have long term negative impacts. Volunteers are often used to deliver such interventions. This scoping review aimed to explore the roles and characteristics of volunteers across early years interventions and map the evaluation in this field to identify gaps in the literature. A scoping review was conducted according to the Arksey and O’Malley Framework. Academic databases and grey literature sources were searched to identify literature evaluating volunteer-based interventions for parents in the first 1001 days of their infant’s life (conception to aged two). Research conducted in the UK or comparable high-income countries since the year 2000 were identified and data relating to the volunteer role, intervention design and evaluation methods were mapped. Sixty-six articles were eligible for inclusion in the review. Volunteers were commonly involved in interventions to provide peer support for a range of parenting related matters, support breastfeeding and the mental and emotional wellbeing of parents. Volunteer roles were categorised based on their background (peers or non-peer volunteers), their responsibilities (provider of peer support, educator or providers of practical support) and the delivery style of their role (in person one to one support, group leader or remote support). Research most often involved exploring the experiences of those involved in receiving or delivering the interventions and measuring outcomes in relation to breastfeeding and parent mental wellbeing. Volunteers play a large role in the provision of early years interventions. Their varied contribution is presented through a typology that will allow comparisons of roles in future research. Further research exploring the impact on the volunteers and the organisation will support decision making around choosing a volunteer led model within early years services.

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. 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. 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. 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. 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.

Social emotional development in infancy is a predictor of outcomes in later life, yet there is little evidence of effectiveness for parenting interventions designed to enhance social emotional wellbeing in infancy. An 18-month two-arm randomized controlled pilot trial evaluated the feasibility of a definitive trial of Incredible Years (IY) Infant and Toddler parent programs delivered in a proportionate universal model, called Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE) Steps. Intervention families received an IY Babies book (universal dose), followed by the IY Infant and/or the Toddler group-based programs, based on parent depression (PHQ-9) and/or child social emotional development (ASQ:SE-2) scores. Control parents received services as usual. Parents from two English local authorities with a child eight-weeks-old or younger participated, and were block randomized using a web-based system. Primary endpoints for the study were feasibility parameters relating to recruitment, retention, intervention fidelity and appropriateness of measures. 205 participants were randomized (152:53, intervention:control). Our target was 288 parents. Trial retention rate was higher than expected, with a completion rate of 88% (n = 181, 137:44) at follow-up 3; equating to 94% of 192 expected participants. Intervention uptake was lower than expected. Fidelity of delivery was acceptable and measures were deemed appropriate. A definitive trial is feasible with design amendments to include: introduction of a child screener for intervention eligibility; enhanced intervention material; revised sample size and random allocation ratio. Our internal pilot became an external pilot due to these changes. Highlights This is the first pilot of a proportionate universal delivery of the IY parent program. Trial retention was high at 88% at final follow-up (18 months post baseline). Emerging findings suggest a definitive trial of E-SEE STEPS is warranted. Definitive trials should consider methods to enhance intervention uptake. Trials should consider intervention compliance with relevant guidelines.

Therapeutic antibodies have revolutionised treatment of some cancers and improved prognosis for many patients. Over half of those available are approved for haematological malignancies, but efficacious antibodies for solid tumours are still urgently needed. Clinically available antibodies belong to the IgG class, the most prevalent antibody class in human blood, while other classes have not been extensively considered. We hypothesised that the unique properties of IgE, a class of tissue-resident antibodies commonly associated with allergies, which can trigger powerful immune responses through strong affinity for their particular receptors on effector cells, could be employed for passive immunotherapy of solid tumours such as ovarian and breast carcinomas. Our laboratory has examined this concept by evaluating two chimaeric antibodies of the same specificity (MOv18) but different isotype, an IgG1 and an IgE against the tumour antigen folate receptor α (FRα). The latter demonstrates the potency of IgE to mount superior immune responses against tumours in disease-relevant models. We identified Fcε receptor-expressing cells, monocytes/macrophages and eosinophils, activated by MOv18 IgE to kill tumour cells by mechanisms such as ADCC and ADCP. We also applied this notion to a marketed therapeutic, the humanised IgG1 antibody trastuzumab and engineered an IgE counterpart, which retained the functions of trastuzumab in restricting proliferation of HER2/ neu -expressing tumour cells but also activated effector cells to kill tumour cells by different mechanisms. On-going efficacy, safety evaluations and future first-in-man clinical studies of IgE therapeutics constitute key metrics for this concept, providing new scope for antibody immunotherapies for solid tumours.

The Birmingham Brighter Futures strategy was informed by epidemiological data on child well-being and evidence on \"what works,\" and included the implementation and evaluation of three evidence-based programmes in regular children's services systems, as well as an integrated prospective cost-effectiveness analysis (reported elsewhere). A randomised controlled trial (RCT) of the Incredible Years BASIC parenting programme involved 161 children aged three and four at risk of a social-emotional or behavioural disorder. An RCT of the universal PATHS social-emotional learning curriculum involved children aged four-six years in 56 primary schools. An RCT of the Level 4 Group Triple-P parenting programme involved parents of 146 children aged four-nine years with potential social-emotional or behavioural disorders. All three studies used validated standardised measures. Both parenting programme trials used parentcompleted measures of child and parenting behaviour. The school-based trial used teacher reports of children's behaviour, emotions, and social competence. Incredible Years yielded reductions in negative parenting behaviours among parents, reductions in child behaviour problems, and improvements in children's relationships. In the PATHS trial, modest improvements in emotional health and behavioural development after one year disappeared by the end of year two. There were no effects for Triple-P. Much can be learned from the strengths and limitations of the Birmingham experience. [PUBLICATION ABSTRACT]

This chapter focuses on programme fidelity in relation to parenting interventions. It discusses the importance of fidelity, outlines strategies for promoting fidelity, and emphasises fidelity and evidence‐based parenting programmes. Two major barriers to high fidelity are intervention complexity and a lack of fidelity‐facilitation strategies, such as the provision of manuals, guidelines, training, monitoring and feedback, capacity building and incentives. With these obstacles in mind, six ways to promote programme fidelity are described in the chapter. The same programmes also stress aspects of adherence (e.g., the importance of role play rehearsal of new skills) and quality and user engagement (e.g., the importance of the practitioner building a reciprocal relationship with parents). While much about fidelity remains unknown, it is important to measure fidelity in efficacy and effectiveness studies because these fidelity constructs can help to explain the results.