Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts.

Background/aims: The value of using qualitative methods within clinical trials is widely recognised. How qualitative research is integrated within trials units to achieve this is less clear. This paper describes the process through which qualitative research has been integrated within Cardiff University's Centre for Trials Research (CTR) in Wales, UK.

Nurse-led home-visitation programme for first-time mothers in reducing maltreatment and improving child health and development (BB:2-6): longer-term outcomes from a randomised cohort using data linkage.

Objectives: Measure effectiveness of family nurse partnership (FNP) home-visiting programme in reducing maltreatment and improving maternal health and child health, developmental and educational outcomes; explore effect moderators, mediators; describe costs.

Design: Follow-up of BB:0-2 trial cohort (ISRCTN:23019866) up to age 7 years in England using record linkage.

Participants: 1618 mothers aged 19 years or younger and their firstborn child(ren) recruited to BB:0-2 trial at less than 25 weeks gestation and not mandatorily withdrawn from trial or opted out.

What are the challenges when recruiting to a trial in children's social care? A qualitative evaluation of a trial of foster carer training.

Background: Randomised controlled trials (RCTs) are comparatively rare in UK social work, but can offer distinct advantages. Confidence in Care (CiC) is an RCT with embedded process evaluation evaluating Fostering Changes (FC), a 12-week training programme for foster and kinship carers to increase skills and coping strategies. In order to mitigate challenges in participant recruitment, an engagement strategy was designed to maximise this.

Childbirth Related Labial Trauma Management in the UK: A Brief Report.

Trauma to the labia occurs in up to 49% of vaginal births. Trauma to the perineal body resulting from childbirth is well defined using widely used categories, and recommended management of perineal body trauma is based on high level evidence. Currently no similar evidence exists to inform the classification or management of labial trauma.

Establishing the safety of waterbirth for mothers and babies: a cohort study with nested qualitative component: the protocol for the POOL study.

Introduction: Approximately 60 000 (9/100) infants are born into water annually in the UK and this is likely to increase. Case reports identified infants with water inhalation or sepsis following birth in water and there is a concern that women giving birth in water may sustain more complex perineal trauma. There have not been studies large enough to show whether waterbirth increases these poor outcomes.

Do home visiting programmes improve children's language development? A systematic review.

Objectives: This review examines home visiting programmes that specifically provide home based support to vulnerable, socially disadvantaged women who are either pregnant or have recently become a new parent. Home visiting programmes often report multiple outcomes. The purpose of this review is to systematically summarise how effective home visiting programmes are at improving young children's language development.

Pregnancy and weight monitoring: A feasibility study of weight charts and midwife support.

Around half of pregnant women in the United Kingdom are overweight or obese. The antenatal period provides an opportunity for encouraging women to adopt positive lifestyle changes, and in recent years, this has included development of strategies to support women in avoiding excessive gestational weight gain. The objective of this interventional cohort study was to incorporate individualised gestational weight monitoring charts supported by motivational interviewing (MI)-based conversations into midwifery-led antenatal care and assess potential of the intervention for further development and evaluation.

Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial.

Objective: To determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis.

Design: A multicentre randomised controlled trial (January 2008/October 2013).

Setting: Eight paediatric diabetes centres in England, Wales and Northern Ireland.

Longitudinal studies examining the impact of prenatal and subsequent episodes of maternal depression on offspring antisocial behaviour.

Maternal depression is associated with adverse child outcomes including antisocial behaviour (ASB). Prospective longitudinal studies have focused on the timing and cumulative exposure to maternal depression to further delineate the association and mechanisms of effect. The objective of this systematic review was to synthesise and evaluate the findings of longitudinal studies of maternal depression and offspring antisocial behaviour.

Controlled Antenatal Thyroid Screening II: Effect of Treating Maternal Suboptimal Thyroid Function on Child Behavior.

Context & Objectives: The Controlled Antenatal Thyroid Screening (CATS) study was the first randomized controlled trial to investigate effects of treating suboptimal gestational thyroid function (SGTF) on child cognition. Since observational studies indicated that SGTF may also increase symptoms of autism and attention-deficit/hyperactivity disorder (ADHD), the CATS cohort was used to investigate whether treatment of mothers affected their children's behavior.

Design & Participants: Mothers (N = 475) completed 3 questionnaires: the Strengths and Difficulties Questionnaire (SDQ), the Child ADHD Questionnaire, and the Social Communication Questionnaire (SCQ, used as a screen for autism spectrum disorder [ASD]), about their children (mean age 9.

Factors influencing the use of birth pools in the United Kingdom: Perspectives of women, midwives and medical staff.

Objective: To identify factors influencing the use of birth pools.

Design: Online discussion groups and semi-structured interviews, analysed thematically.

Setting: United Kingdom.

Implementation of the Family Nurse Partnership programme in England: experiences of key health professionals explored through trial parallel process evaluation.

Background: The Family Nurse Partnership (FNP) programme was introduced to support young first-time mothers. A randomised trial found FNP added little short-term benefit compared to usual care. The study included a comprehensive parallel process evaluation, including focus groups, conducted to aid understanding of the introduction of the programme into a new service and social context.

The impact of postpartum psychosis on partners.

Background: Postpartum Psychosis is a severe mental health condition following childbirth, with a psychosis and associated mood disturbance. Research to date has primarily focused on mothers' experiences, and on identifying risk factors, aetiology, and intervention efficacy. Within both research and clinical communities, there has been little acknowledgement of partners' experiences of Postpartum Psychosis, nor the important support role that partners can provide.

Feasibility and acceptability of a motivational interviewing breastfeeding peer support intervention.

An uncontrolled study with process evaluation was conducted in three U.K. community maternity sites to establish the feasibility and acceptability of delivering a novel breastfeeding peer-support intervention informed by motivational interviewing (MI; Mam-Kind).

What is usual care for teenagers expecting their first child in England? A process evaluation using key informant mapping and participant survey as part of the Building Blocks randomised controlled trial of specialist home visiting.

Objectives: We compared the US-derived Family Nurse Partnership (FNP) home visiting programme when added to usually provided health and social care for first-time teenage mothers, to usual care alone. We aimed to: establish the nature of usual care, measure service usage and assess performance bias in core usual care services.

Design: Within trial process evaluation.

Controlled Antenatal Thyroid Screening II: Effect of Treating Maternal Suboptimal Thyroid Function on Child Cognition.

Context And Objective: The Controlled Antenatal Thyroid Screening (CATS) study investigated treatment of suboptimal gestational thyroid function (SGTF) on childhood cognition and found no difference in intelligence quotient (IQ) at 3 years between children of treated and untreated SGTF mothers. We have measured IQ in the same children at age 9.5 years and included children from normal gestational thyroid function (normal-GTF) mothers.

Evaluating the long-term impact of the Fostering Changes training programme for foster carers in Wales, the Confidence in Care trial: study protocol for a randomised controlled trial.

Background: The Fostering Changes programme was developed by the Adoption and Fostering National Team at the Maudsley Hospital, South London, in conjunction with King's College London. It is a 12-week group-based training programme for foster and kin carers, which aims to build positive relationships between carers and children, encourage positive child behaviour and set appropriate limits, through a practical skills-based approach. The programme also aims to improve foster carers' understanding of the causes of children's social and emotional difficulties and their confidence in applying this knowledge in various situations.

Assessing the medium-term impact of a home-visiting programme on child maltreatment in England: protocol for a routine data linkage study.

Introduction: Child maltreatment involves acts of omission (neglect) or commission (abuse) often by caregivers that results in potential or actual harm to a child. The Building Blocks trial (ISRCTN23019866) assessed the short-term impact of an intensive programme of antenatal and postnatal visiting by specially trained nurses to support young pregnant women in England. The Building Blocks: 2-6 Study will assess the medium-term impacts of the programme for mothers and children (n=1562), through the linkage of routinely collected data to the trial data, with a particular emphasis on the programme's impact on preventing child maltreatment.

Motivational interviewing competencies among UK family nurse partnership nurses: a process evaluation component of the building blocks trial.

Background: Motivational Interviewing (MI) is a person-centred counselling approach to behaviour change which is increasingly being used in public health settings, either as a stand-alone approach or in combination with other structured programmes of health promotion. One example of this is the Family Nurse Partnership (FNP) a licensed, preventative programme for first time mothers under the age of 20, delivered by specialist family nurses who are additionally trained in MI. The Building Blocks trial was an individually randomised controlled trial comparing effectiveness of Family Nurse Partnership when added to usual care compared to usual care alone within 18 sites in England.

Feasibility of Parent-to-Parent Support in Recently Diagnosed Childhood Diabetes: The PLUS Study.

Purpose: The purpose of this study was to develop and test the feasibility of a parent-to-parent support intervention for parents whose child has recently been diagnosed with type 1 diabetes in the United Kingdom.

Methods: The research team conducted a formative evaluation, working with parents to design an individual-level parent-to-parent support intervention. Issues of recruitment, uptake, attrition, pattern of contact, and intervention acceptability were assessed.

Experiences of using pro-eating disorder websites: a qualitative study with service users in NHS eating disorder services.

Purpose: Previous research into the impact of pro-eating disorder (pro-ED) websites has predominantly been undertaken using experimental and survey designs. Studies have used both clinical and non-clinical (college student) samples. The present study aimed to explore the underlying functions and processes related to the access and continued use of pro-ED websites within a clinical eating disorder population using a qualitative research design.

Effectiveness of a nurse-led intensive home-visitation programme for first-time teenage mothers (Building Blocks): a pragmatic randomised controlled trial.

Background: Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children. The Family Nurse Partnership (FNP) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in England that involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained family nurses. We aimed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth.

The second wave of the Controlled Antenatal Thyroid Screening (CATS II) study: the cognitive assessment protocol.

Background: Children whose mothers had low thyroid hormone levels during pregnancy have been reported to have decreased cognitive function. The reported research is part of the follow-on study of the Controlled Antenatal Thyroid Screening Study (CATS I), a randomised controlled trial which investigated the impact of treated vs. untreated low thyroid hormone level in women during pregnancy with the primary outcome being the child's IQ at age 3.