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Additional file 1.

BackgroundThe short-term effectiveness (to 24 months post partum) of a preventative home-visiting intervention, the Family Nurse Partnership, was previously assessed in the Building Blocks trial (BB:0–2).ObjectivesThe objectives were to establish the medium-term effectiveness of the Family Nurse Partnership in reducing maltreatment and improving maternal health (second pregnancies) and child health, developmental and educational outcomes (e.g. early educational attendance, school readiness); to explore effect moderators and mediators; and to describe the costs of enhancing usually provided health and social care with the Family Nurse Partnership.DesignChildren and their mothers from an existing trial cohort were followed up using routine data until the child was 7 years of age.SettingThis study was set in 18 partnerships between local authorities and health-care organisations in England.ParticipantsThe participants were mothers [and their firstborn child(ren)] recruited as pregnant women aged ≤ 19 years, in local authority Family Nurse Partnership catchment areas, at InterventionsThe intervention comprised up to a maximum of 64 home visits by specially trained family nurses from early pregnancy until the firstborn child was 2 years of age, plus usually provided health and social care support. The comparator was usual care alone.Main outcome measuresThe primary outcome measure was child-in-need status recorded at any time during follow-up. The secondary outcomes were as follows: (1) referral to social services, child protection registration (plan), child-in-need categorisation, looked-after status, recorded injuries and ingestions at any time during follow-up; (2) early child care and educational attendance, school readiness (Early Years Foundation Stage Profile score) and attainment at Key Stage 1; and (3) health-care costs.Data sourcesThe following data sources were used: maternally reported baseline and follow-up data (BB:0–2), Hospital Episode Statistics data (NHS Digital), social care and educational data (National Pupil Database) and abortions data (Department of Health and Social Care).ResultsThere were no differences between study arms in the rates of referral to social services, being registered as a child in need, receiving child protection plans, entering care or timing of first referral for children subsequently assessed as in need. There were no differences between study arms in rates of hospital emergency attendance, admission for injuries or ingestions, or in duration of stay for admitted children. Children in the Family Nurse Partnership arm were more likely to achieve a good level of development at reception age (school readiness), an effect strengthened when adjusting for birth month. Differences at Key Stage 1 were not statistically different, but, after adjusting for birth month, children in the Family Nurse Partnership arm were more likely to reach the expected standard in reading. Programme effects were greater for boys (Key Stage 1: writing); children of younger mothers (Key Stage 1: writing, Key Stage 1: mathematics); and children of mothers not in employment, education or training at study baseline (Key Stage 1: writing). There were no differences between families who were part of the Family Nurse Partnership and those who were not for any other outcome. The differences between study arms in resource use and costs were negligible.LimitationsThe outcomes are constrained to those available from routine sources.ConclusionsThere is no observable benefit of the programme for maltreatment or maternal outcomes, but it does generate advantages in school readiness and attainment at Key Stage 1.Future workThe trajectory of longer-term programme benefits should be mapped using routine and participant-reported measures.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 9, No. 2. See the NIHR Journals Library website for further project information.

Additional file 1.

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. Methods This is a pragmatic open-label individually randomised controlled trial, with embedded process evaluation. A total of 237 participants will be recruited from Welsh Local Authorities and Independent Fostering Providers; those allocated to the intervention group will be offered enrolment in the next Fostering Changes programme group at their site. Participants in the control group will be offered the Fostering Changes programme at the end of the follow-up period. Data will be collected at baseline, immediately following the 12 week Fostering Changes intervention, and 12 months from the start of the Fostering Changes programme. The primary outcome measure assesses the extent to which carers feel able to cope with and make positive changes to the lives of their foster children and is measured by the Carer Efficacy Questionnaire at 12 months. Discussion The trial will determine whether the Fostering Changes programme, in the long term, can deliver important, significant differences to the way foster carers build positive relationships with their foster children, encourage positive child behaviour and set appropriate limits, compared with usual care. Trial registration International Standard Randomised Controlled Trial Number, ISRCTN19090228. Registered on 11 January 2017. Electronic supplementary material The online version of this article (10.1186/s13063-017-2424-3) contains supplementary material, which is available to authorized users.

References for table (additional file 2) containing data for each of the studies included in review. (DOCX 47 kb)

Prevalence of abuse by type and population. (DOCX 28 kb)

Prevalence of maltretment by continent and gender - non-clinical samples only. (DOCX 81 kb)

SPIRIT checklist. (DOCX 23 kb)

Inclusion and exclusion criteria applied to the literature. (DOCX 12 kb)

Evidence supporting progression derived from trial (BB:0â 2) and feasibility study (BB: 2â 6) phases. Detailed progression criteria as set out by the study funder at the start of the project to ensure research objectives could be met. (DOCX 35 kb)

Table containing data for each of the studies included in review. (DOCX 73 kb)

Objectives There is an ongoing need to involve and inform the public about data linkage research. Projects at the South East Wales Trials Unit (SEWTU) and Division of Population Medicine, Cardiff University have focused on participant and public understanding of, and attitudes towards the use of routine/linked data for research purposes. Approach HealthWise Wales is a Welsh national cohort using prospectively collected data linked with NHS records. Face-to-face and online focus groups were conducted to explore the barriers and facilitators to signing up to this project as well as discussing the best way to communicate the technical details of the project. MINIMAL PhD conducted a focus group with care-experienced young people to gather attitudes towards the collection and linkage of child maltreatment data. The Public and Patient Involvement activities of the Building Blocks 2-6 Study included meetings with a young mothers group utilising their skills as advisors on communicating data linkage issues with study participants. These projects have been undertaken independently however comprise the same underlying questions – Do the public understand why routine & linked data is used for research? Will this be a barrier to participating? How can we communicate study design to ensure participants are fully informed? This presentation will summarise the similarities and contrasting attitudes and beliefs emerging from these projects. Results We have identified similar emerging themes from both the HealthWise Wales focus groups and MINIMAL PhD focus groups. Participants found it challenging to understand the methodology of data linkage and this acted as a barrier to taking part in data linkage projects. Once participants felt fully informed of the method, their concerns around data safety and confidentiality were reduced. Participants required assurances that their data were safe, that they could not be identified, and that researchers can be trusted to access these data before considering the research project in discussion. Participants also discussed the collection of sensitive data from various sources through data linkage, consent issues, and the balance between research risk/benefit for the MINIMAL PhD focus group. Conclusion These qualitative studies will contribute to knowledge of how to better inform members of the public about routine / linked data, as it is clear than there remains a lack of understanding of the research conducted in this area, and the importance for researchers to utilise these data. Researchers need to get the communication right in order to be successful at recruiting and retaining participants.

Background\ud Nationally and internationally, there has been a growing recognition of the importance of identifying, documenting and reporting suspected and confirmed child maltreatment. Formally collected data on the extent of child maltreatment in social services and criminal justice\ud records are likely to be an underestimate of actual cases.\ud Aims\ud The aims of this study are firstly to introduce the problem of child maltreatment. Secondly, to explore mothers, care-experienced young people and professional attitudes regarding the collection and linkage of maltreatment data for research. Thirdly, to investigate how markers and risk factors of maltreatment relate to outcomes that may indicate maltreatment, and to\ud illustrate this using case studies.\ud Methods\ud The study involves formally reviewing the background to each research question by structured literature review. The study takes a mixed-methods approach. Secondary regression analysis of data explored potential risk factors and markers of outcomes that may indicate maltreatment. Exploratory focus group interviews with mothers, care-experienced young people and professional stakeholders were conducted.\ud Findings\ud When exploring mothers, care-experienced young people and professionals’ attitudes towards collecting and linking maltreatment data for research three major themes were identified:consent, trust and understanding. Mothers with outcomes that may indicate maltreatment in their child were more likely to have higher parental stress, be more deprived, and show their child negativity. They were also more likely to have a child attending A&E with a nerve,\ud contusion, head or ano-genital injury, with a congenital abnormality, and themselves had a higher number of antenatal check-ups. When collecting data on child maltreatment researchers should not utilise a dataset containing a subset of participants as the main\ud population. They should not utilise a dataset less complete than another, and be mindful that self-report may be less reliable than routinely collected data. Case studies were useful in gaining a deeper understanding of the pattern of variables that could be related to outcome.