Exploring the mechanisms through which specialist home visiting produces health and well-being benefits for families.

BACKGROUND

(i) Specialist home visiting to support new families:

The Family Nurse Partnership (FNP) was developed and licensed by the University of Colorado as a voluntary, preventive programme for vulnerable young first time mothers. It offers intensive and structured home visiting, delivered by specially trained nurses, from early pregnancy until age two. The three aims are: to improve pregnancy outcomes, improve child health and development and improve parents’ economic self-sufficiency.

A strong and rigorous US evidence base, developed over 30 years, has shown FNP benefits the neediest young families in the short, medium, and long term across a wide range of outcomes helping improve social mobility and break the cycle of inter-generational disadvantage and poverty.

(ii) Work to establish the programme in the UK and the Cardiff evaluations:

The programme was adapted for implementation and introduced in England in 2007. Due to the greatly differing nature of publicly funded health and social care service provision and socio-cultural context between England and the US, the relative benefits of the programme need to be replicated in England and costs determined before wide-spread implementation can be recommended. The study team have conducted two definitive evaluations:

BB:0-2 - Department of Health and Social Care (DHSC) commissioned the ‘Building Blocks’ randomised controlled trial (RCT) from Cardiff University to provide independent evidence on the effectiveness of the FNP programme in improving short term outcomes for young parents and their babies. The trial began in 2009 and the findings which cover the period from pregnancy to the child’s second birthday' were published in October 2015. The FNP described these as “important early findings and add to the evidence the study team have from the US, Netherlands and other early evaluation in England to help improve FNP in England.”

BB: 2-6 - The National Institute of Health Research further funded Cardiff University to undertake a follow up study to examine child and maternal outcomes to age six. This built on the original study to examine the longer-term impact of FNP intervention. Its principal objective was to determine the effectiveness of the FNP programme in reducing objectively measured long-term maltreatment outcomes when compared to usually provided health and social care alone. The main research outcomes were child in need status, child protection registration, referral to social care. Other indicators of programme impact included measures of injuries and ingestions and hospital DNA rates. The study report has been externally peer reviewed and was published by NIHR in February 2021: https://www.journalslibrary.nihr.ac.uk/phr/phr09020/#/full-report.

The main journal article is published here: https://bmjopen.bmj.com/content/bmjopen/12/2/e049960.full.pdf

In the BB:2-6 study, Cardiff University followed-up the cohort of mothers and children who took part in the first Building Blocks trial (BB:0-2) by obtaining health and mortality data from NHS England, data from Department for Education (DfE) and data from the Department of Health (abortion statistics) and linked with the original trial data.

(iii) Evidence from the Cardiff work and NHS England supplied data to date

The original Building Blocks trial (BB:0-2) provided evidence for the short-term effectiveness of the programme (up to 2 years after birth). The Building Blocks: 2-6 (BB:2-6) study has now provided evidence for the medium-term effectiveness and costs of one of the most promising early intervention programmes for reducing risk of child maltreatment in a targeted vulnerable population. Specifically, data requested from NHS England provided the basis for key study outcomes which are indicators of maltreatment. Both studies have provided evidence which has informed policy decision-making at both national and local level about whether to continue implementing the programme and also changes to programme content, format and delivery.

OBJECTIVES OF THIS STUDY

In 2019/20, the study team received additional funding to analyse pseudonymised study data already held in the data safe haven (which includes NHS England supplied data provided under DARS-NIC-333498-D1K7G). These analyses explore the mechanisms by which specialist home visiting may have its effect for recipient families. Two funders (Nuffield Foundation, European Research Council (ERC)) provided resources to support the two separate analyses both of which utilise the same existing data set.

Proposed analyses funded by ERC and Nuffield Trust:

The analyses explore the mechanisms by which specialist home visiting may have its effect for recipient families. The analyses to date have determined the impact of the home visiting intervention upon a wide range of family outcomes. These range from the antenatal period through to early in children’s school life (i.e. at key stage 1). The study team explored how home visiting has benefited some families but has been less effective for others. The study team also assessed the additional benefit that receiving more home visits has had for some of the more important outcomes that have been assessed. The study team explored the perceptions of both mothers and family nurses (i.e. the professionals who deliver home visits to families) about how the home visiting may exert its effect (and what may be a barrier to its effectiveness). The study team explored how some outcomes (such as children being designated as In Need by local departments of children’s services) are influenced by a range of potential risk factors (for example, attributes of the mother and child).

The analysis takes an econometric approach to explore how the benefits of the home visiting intervention are produced. The study explores the mechanisms through which the home visiting intervention is hypothesised to produce benefits (for example, whether expected changes in maternal behaviour occur and whether these then lead to other improvements). The study explores how characteristics of nurses plays any part in observed effects (for example, whether some nurses are associated with more or less improvement. This may be due to differences in clinical experience or training, for example). It explores further how home visiting dose and quality may be linked to differential family benefits (visit-level data available for each mother in receipt of specialist home-visiting provides detail on how many visits were delivered, their duration and the content addressed using the scheme’s standard monitoring form). Finally, the study assesses how reported use of other public sector services may also have an influence. The existing trial cohort data (including Data provided by NHS England) has been analysed using state-of-the-art economics methods, benefiting from the input of the lead investigator who secured the additional funding. The analysis dynamically models the study data to establish more clearly than has been possible previously how the home visiting programme produces benefits for families.

The two analyses (Nuffield and ERC) use an existing pseudonymised data set supplied by NHS England under DARS-NIC-333498-D1K7G-v4.4. The first (Nuffield), involves two similar study cohorts being assessed in the new analyses (the other being from a study in Germany which implemented a similar intervention). The analyses for the two cohorts run in parallel (i.e. the data will remain where currently located) but similar research questions were asked of the two study datasets. NHS England Data held by Cardiff as data controller will not be shared or linked to the German data. Only derived outputs are compared when interpreting the outputs from the two analyses. The second funded analysis (ERC) involves a broader range of data drawn from a variety of sources these include: distance from / price of / availability of goods and services for children (e.g. price of toys, distance from GP/parks, food prices); and prices of cigarettes, alcohol and local wages. Like the Nuffield funded work, the ERC analyses involve data from the Building Blocks trial cohort being analysed separately from any other project data but will share a common underlying research question and specialist economics methods. For the analysis of the Building Blocks dataset more detailed exploration of (non-NHS) trial data based on existing post code is used to determine the role of local context (including policies) upon family outcomes, no attempt will made to identify or link the data.

The two project grants are led by a member of staff at UCL and the analyses is undertaken by the research fellow and themselves, both of whom are substantive employees of UCL. Access to the Data is approved by the study lead at Cardiff University. All analyses is reviewed and approved by the study lead at Cardiff University. This study lead is the chief investigator and is costed into both grants to provide these approvals and oversee all outputs from the study. A statistician based in Cardiff and approved to access the cohort dataset has responsibility to review the statistical analysis plan for both Nuffield and ERC-funded studies.

Cardiff University was the Controller (and sponsor) of the original study and Swansea University (and Cardiff University) were Processors, however Swansea are no-longer involved in any capacity. This agreement includes UCL as a joint controller who processes data. UCL make decisions on the manner of data processing, and the two project grants are led by a member of staff from UCL. The additional funded work is funded by both the European Research Council and Nuffield Trust. Neither body may make decisions related to how the data are processed and will not have access to the data. The Chair of the Information Governance Review Panel at SAIL (Swansea University) confirmed that as the data being accessed in relation to the study are appropriately anonymised, no further ethical review was required.

The UK GDPR legal basis for processing NHS England data are: Article 6:1(e):This project is a task in the public interest because it was commissioned by the Department of Health to evaluate the impact of home-visiting interventions on child maltreatment; and, Article 9:2(j):This is scientific research which uses only the data required to answer these important research aims, using a data safe haven to protect the data and outputs this research will directly influence policy making regarding home visiting programmes to benefit the UK public.

DATA SUBJECTS

The cohort consists of 1645 women (and their first-born child(ren)) who met eligibility criteria for participation in the Building Blocks trial of the Family Nurse Partnership (FNP) and were nulliparous (a woman who has never given birth either by choice or for any other reason. This term also applies to women who have given birth to a stillborn baby, or a baby who was otherwise not able to survive outside the womb) women aged 19 or under, living in one of 18 local authority FNP catchment areas in England who were recruited by 24+6 weeks gestation, had conversational level of English and were able to consent to research.

Women were recruited by locally-based research professionals usually employed by local NHS organisations following identification through NHS maternity units. Women provided their written informed consent to participate including for data in their administrative health records to be provided to the research team.

Relevant Data for the study cohort provided by NHS England under DARS-NIC-333498-D1K7G-v4.4 include: Civil Registrations of Death; Hospital Episode Statistics A&E; Outpatients; and, Admitted Patient Care. These data were used to follow-up mothers recruited into the study and their babies, up until the baby’s second birthday. These datasets are the main source of data for two of the primary outcomes (and several secondary outcomes).

The BB:0-2 trial began in 2009 and the findings which cover the period from pregnancy to the child’s second birthday' were published in October 2015 and available here: https://doi.org/10.1016/S0140-6736(15)00392-X

The National Institute of Health Research funded BB:2-6 study follow up study examined child outcomes to age six, building on the original study examining the longer term impact of FNP intervention. A subsequent application for data from NHS England (DARS-NIC-333498-D1K7G) permitted collection of the same health data for an additional four years, until the mother’s first child(ren) was aged six years old. As identifiable data were required to enable linkage of the original trial cohort data to these new records, section 251 approval was given.

The Building Blocks study originally involved a lay group who advised on aspects of trial delivery and provided input into the design and setup of the study. An independent group of young people also provided advice to the research team and a lay perspective on the general management and delivery of the project and in particular the preparation of the outputs from the study.

The results will be of relevance to many different audiences: policymakers at the Department for Education (DfE) and at Department for Health and Social Care (DHSC), and at Public Health England (PHE) in England; at the “National Centre on Early Prevention” (Nationales Zentrum Frühe Hilfen, NZFH), the Ministry for Social Affairs, Health, Women and Family in the German Republic of Saarland and the Federal Ministry of Family Affairs, Senior Citizens, Women and Youth in Germany; the National Health Service (NHS) in England; think tanks; local authorities; practitioners; advocacy groups; media and commentators; and the academic community across several disciplines, ranging from economics to psychology and child development.

The main academic project outputs will be at least two journal articles (one for each study analysis). For the two main publications the study team will target two top economics journals. Upon project completion and in adherence with the publication plan, the study team will consider submitting specific findings for publication in child development or public health journals, to facilitate dissemination to a wider audience. The publication of the report will be advertised through a press release, and the study team will also organize an end-of-project workshop, where academics, practitioners and representatives from FNP, DfE, DHSC, PHE and NHS will be invited to discuss the implications of the findings. To make sure this will reach out to the relevant policy circles, the study team will exploit the fact that the Principal investigator is a Trustee of the Foundation Years Information and Research Group. The Group devoted its yearly seminar series in 2016/2017 to the FNP, and visited the Ministry for Social Affairs, Health, Women and Family in the German Republic of Saarland to study their home visiting programmes in January 2018.

All access for analysis is to anonymised data.. No identifiable data will be accessed. Published results will only contain aggregated data with small numbers suppressed. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Initial (main) academic outputs and secondary outputs were expected by Summer 2022. Most analyses have been completed but some remain. To allow for completion of the analysis, including the necessity to respond to peer review feedback on outputs, the study team wish to extend the DSA to October 2025.

The original Building Blocks trial (BB:0-2) provided evidence for the short-term effectiveness of the programme (up to 2 years after birth). The Building Blocks: 2-6 (BB:2-6) study has now provided evidence for the medium-term effectiveness and costs of one of the most promising early intervention programmes for reducing risk of child maltreatment in a targeted vulnerable population. Both studies have provided evidence which has informed policy decision-making at both national and local level about whether to continue implementing the programme and also changes to programme content, format and delivery.

BACKGROUND

(i) Specialist home visiting to support new families:

The Family Nurse Partnership (FNP) was developed and licensed by the University of Colorado as a voluntary, preventive programme for vulnerable young first time mothers. It offers intensive and structured home visiting, delivered by specially trained nurses, from early pregnancy until age two. The three aims are: to improve pregnancy outcomes, improve child health and development and improve parents’ economic self-sufficiency.

A strong and rigorous US evidence base, developed over 30 years, has shown FNP benefits the neediest young families in the short, medium, and long term across a wide range of outcomes helping improve social mobility and break the cycle of inter-generational disadvantage and poverty.

(ii) Work to establish the programme in the UK and the Cardiff evaluations:

The programme was adapted for implementation and introduced in England in 2007. Due to the greatly differing nature of publicly funded health and social care service provision and socio-cultural context between England and the US, the relative benefits of the programme need to be replicated in England and costs determined before wide-spread implementation can be recommended. The study team have conducted two definitive evaluations:

BB:0-2 - Department of Health and Social Care (DHSC) commissioned the ‘Building Blocks’ randomised controlled trial (RCT) from Cardiff University to provide independent evidence on the effectiveness of the FNP programme in improving short term outcomes for young parents and their babies. The trial began in 2009 and the findings which cover the period from pregnancy to the child’s second birthday' were published in October 2015. The FNP described these as “important early findings and add to the evidence the study team have from the US, Netherlands and other early evaluation in England to help improve FNP in England.”

BB: 2-6 - The National Institute of Health Research further funded Cardiff University to undertake a follow up study to examine child and maternal outcomes to age six. This built on the original study to examine the longer-term impact of FNP intervention. Its principal objective was to determine the effectiveness of the FNP programme in reducing objectively measured long-term maltreatment outcomes when compared to usually provided health and social care alone. The main research outcomes were child in need status, child protection registration, referral to social care. Other indicators of programme impact included measures of injuries and ingestions and hospital DNA rates. The study report has been externally peer reviewed and was published by NIHR in February 2021: https://www.journalslibrary.nihr.ac.uk/phr/phr09020/#/full-report.

The main journal article is published here: https://bmjopen.bmj.com/content/bmjopen/12/2/e049960.full.pdf

In the BB:2-6 study, Cardiff University followed-up the cohort of mothers and children who took part in the first Building Blocks trial (BB:0-2) by obtaining health and mortality data from NHS England, data from Department for Education (DfE) and data from the Department of Health (abortion statistics) and linked with the original trial data.

(iii) Evidence from the Cardiff work and NHS England supplied data to date

The original Building Blocks trial (BB:0-2) provided evidence for the short-term effectiveness of the programme (up to 2 years after birth). The Building Blocks: 2-6 (BB:2-6) study has now provided evidence for the medium-term effectiveness and costs of one of the most promising early intervention programmes for reducing risk of child maltreatment in a targeted vulnerable population. Specifically, data requested from NHS England provided the basis for key study outcomes which are indicators of maltreatment. Both studies have provided evidence which has informed policy decision-making at both national and local level about whether to continue implementing the programme and also changes to programme content, format and delivery.

OBJECTIVES OF THIS STUDY

In 2019/20, the study team received additional funding to analyse pseudonymised study data already held in the data safe haven (which includes NHS England supplied data provided under DARS-NIC-333498-D1K7G). These analyses explore the mechanisms by which specialist home visiting may have its effect for recipient families. Two funders (Nuffield Foundation, European Research Council (ERC)) provided resources to support the two separate analyses both of which utilise the same existing data set.

Proposed analyses funded by ERC and Nuffield Trust:

The analyses explore the mechanisms by which specialist home visiting may have its effect for recipient families. The analyses to date have determined the impact of the home visiting intervention upon a wide range of family outcomes. These range from the antenatal period through to early in children’s school life (i.e. at key stage 1). The study team explored how home visiting has benefited some families but has been less effective for others. The study team also assessed the additional benefit that receiving more home visits has had for some of the more important outcomes that have been assessed. The study team explored the perceptions of both mothers and family nurses (i.e. the professionals who deliver home visits to families) about how the home visiting may exert its effect (and what may be a barrier to its effectiveness). The study team explored how some outcomes (such as children being designated as In Need by local departments of children’s services) are influenced by a range of potential risk factors (for example, attributes of the mother and child).

The analysis takes an econometric approach to explore how the benefits of the home visiting intervention are produced. The study explores the mechanisms through which the home visiting intervention is hypothesised to produce benefits (for example, whether expected changes in maternal behaviour occur and whether these then lead to other improvements). The study explores how characteristics of nurses plays any part in observed effects (for example, whether some nurses are associated with more or less improvement. This may be due to differences in clinical experience or training, for example). It explores further how home visiting dose and quality may be linked to differential family benefits (visit-level data available for each mother in receipt of specialist home-visiting provides detail on how many visits were delivered, their duration and the content addressed using the scheme’s standard monitoring form). Finally, the study assesses how reported use of other public sector services may also have an influence. The existing trial cohort data (including Data provided by NHS England) has been analysed using state-of-the-art economics methods, benefiting from the input of the lead investigator who secured the additional funding. The analysis dynamically models the study data to establish more clearly than has been possible previously how the home visiting programme produces benefits for families.

The two analyses (Nuffield and ERC) use an existing pseudonymised data set supplied by NHS England under DARS-NIC-333498-D1K7G-v4.4. The first (Nuffield), involves two similar study cohorts being assessed in the new analyses (the other being from a study in Germany which implemented a similar intervention). The analyses for the two cohorts run in parallel (i.e. the data will remain where currently located) but similar research questions were asked of the two study datasets. NHS England Data held by Cardiff as data controller will not be shared or linked to the German data. Only derived outputs are compared when interpreting the outputs from the two analyses. The second funded analysis (ERC) involves a broader range of data drawn from a variety of sources these include: distance from / price of / availability of goods and services for children (e.g. price of toys, distance from GP/parks, food prices); and prices of cigarettes, alcohol and local wages. Like the Nuffield funded work, the ERC analyses involve data from the Building Blocks trial cohort being analysed separately from any other project data but will share a common underlying research question and specialist economics methods. For the analysis of the Building Blocks dataset more detailed exploration of (non-NHS) trial data based on existing post code is used to determine the role of local context (including policies) upon family outcomes, no attempt will made to identify or link the data.

The two project grants are led by a member of staff at UCL and the analyses is undertaken by the research fellow and themselves, both of whom are substantive employees of UCL. Access to the Data is approved by the study lead at Cardiff University. All analyses is reviewed and approved by the study lead at Cardiff University. This study lead is the chief investigator and is costed into both grants to provide these approvals and oversee all outputs from the study. A statistician based in Cardiff and approved to access the cohort dataset has responsibility to review the statistical analysis plan for both Nuffield and ERC-funded studies.

Cardiff University was the Controller (and sponsor) of the original study and Swansea University (and Cardiff University) were Processors, however Swansea are no-longer involved in any capacity. This agreement includes UCL as a joint controller who processes data. UCL make decisions on the manner of data processing, and the two project grants are led by a member of staff from UCL. The additional funded work is funded by both the European Research Council and Nuffield Trust. Neither body may make decisions related to how the data are processed and will not have access to the data. The Chair of the Information Governance Review Panel at SAIL (Swansea University) confirmed that as the data being accessed in relation to the study are appropriately anonymised, no further ethical review was required.

The UK GDPR legal basis for processing NHS England data are: Article 6:1(e):This project is a task in the public interest because it was commissioned by the Department of Health to evaluate the impact of home-visiting interventions on child maltreatment; and, Article 9:2(j):This is scientific research which uses only the data required to answer these important research aims, using a data safe haven to protect the data and outputs this research will directly influence policy making regarding home visiting programmes to benefit the UK public.

DATA SUBJECTS

The cohort consists of 1645 women (and their first-born child(ren)) who met eligibility criteria for participation in the Building Blocks trial of the Family Nurse Partnership (FNP) and were nulliparous (a woman who has never given birth either by choice or for any other reason. This term also applies to women who have given birth to a stillborn baby, or a baby who was otherwise not able to survive outside the womb) women aged 19 or under, living in one of 18 local authority FNP catchment areas in England who were recruited by 24+6 weeks gestation, had conversational level of English and were able to consent to research.

Women were recruited by locally-based research professionals usually employed by local NHS organisations following identification through NHS maternity units. Women provided their written informed consent to participate including for data in their administrative health records to be provided to the research team.

Relevant Data for the study cohort provided by NHS England under DARS-NIC-333498-D1K7G-v4.4 include: Civil Registrations of Death; Hospital Episode Statistics A&E; Outpatients; and, Admitted Patient Care. These data were used to follow-up mothers recruited into the study and their babies, up until the baby’s second birthday. These datasets are the main source of data for two of the primary outcomes (and several secondary outcomes).

The BB:0-2 trial began in 2009 and the findings which cover the period from pregnancy to the child’s second birthday' were published in October 2015 and available here: https://doi.org/10.1016/S0140-6736(15)00392-X

The National Institute of Health Research funded BB:2-6 study follow up study examined child outcomes to age six, building on the original study examining the longer term impact of FNP intervention. A subsequent application for data from NHS England (DARS-NIC-333498-D1K7G) permitted collection of the same health data for an additional four years, until the mother’s first child(ren) was aged six years old. As identifiable data were required to enable linkage of the original trial cohort data to these new records, section 251 approval was given.

The Building Blocks study originally involved a lay group who advised on aspects of trial delivery and provided input into the design and setup of the study. An independent group of young people also provided advice to the research team and a lay perspective on the general management and delivery of the project and in particular the preparation of the outputs from the study.

The results will be of relevance to many different audiences: policymakers at the Department for Education (DfE) and at Department for Health and Social Care (DHSC), and at Public Health England (PHE) in England; at the “National Centre on Early Prevention” (Nationales Zentrum Frühe Hilfen, NZFH), the Ministry for Social Affairs, Health, Women and Family in the German Republic of Saarland and the Federal Ministry of Family Affairs, Senior Citizens, Women and Youth in Germany; the National Health Service (NHS) in England; think tanks; local authorities; practitioners; advocacy groups; media and commentators; and the academic community across several disciplines, ranging from economics to psychology and child development.

The main academic project outputs will be at least two journal articles (one for each study analysis). For the two main publications the study team will target two top economics journals. Upon project completion and in adherence with the publication plan, the study team will consider submitting specific findings for publication in child development or public health journals, to facilitate dissemination to a wider audience. The publication of the report will be advertised through a press release, and the study team will also organize an end-of-project workshop, where academics, practitioners and representatives from FNP, DfE, DHSC, PHE and NHS will be invited to discuss the implications of the findings. To make sure this will reach out to the relevant policy circles, the study team will exploit the fact that the Principal investigator is a Trustee of the Foundation Years Information and Research Group. The Group devoted its yearly seminar series in 2016/2017 to the FNP, and visited the Ministry for Social Affairs, Health, Women and Family in the German Republic of Saarland to study their home visiting programmes in January 2018.

All access for analysis is to anonymised data.. No identifiable data will be accessed. Published results will only contain aggregated data with small numbers suppressed. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Initial (main) academic outputs and secondary outputs were expected by Summer 2022. Most analyses have been completed but some remain. To allow for completion of the analysis, including the necessity to respond to peer review feedback on outputs, the study team wish to extend the DSA to October 2025.

The original Building Blocks trial (BB:0-2) provided evidence for the short-term effectiveness of the programme (up to 2 years after birth). The Building Blocks: 2-6 (BB:2-6) study has now provided evidence for the medium-term effectiveness and costs of one of the most promising early intervention programmes for reducing risk of child maltreatment in a targeted vulnerable population. Both studies have provided evidence which has informed policy decision-making at both national and local level about whether to continue implementing the programme and also changes to programme content, format and delivery.

The study team may be in a position to report further yielded benefits following completion of the analysis when main, and secondary outputs have been published and peer reviewed.

(i) Specialist home visiting to support new families:

The Family Nurse Partnership (FNP) was developed and licensed by the University of Colorado as a voluntary, preventive programme for vulnerable young first time mothers. It offers intensive and structured home visiting, delivered by specially trained nurses, from early pregnancy until age two. The three aims are: to improve pregnancy outcomes, improve child health and development and improve parents’ economic self-sufficiency.

A strong and rigorous US evidence base, developed over 30 years, has shown FNP benefits the neediest young families in the short, medium, and long term across a wide range of outcomes helping improve social mobility and break the cycle of inter-generational disadvantage and poverty.

(ii) Work to establish the programme in the UK and the Cardiff evaluations:

The programme was adapted for implementation and introduced in England in 2007. Due to the greatly differing nature of publicly funded health and social care service provision and socio-cultural context between England and the US, the relative benefits of the programme need to be replicated in England and costs determined before wide-spread implementation can be recommended. The study team have conducted two definitive evaluations:

BB:0-2 - Department of Health and Social Care (DHSC) commissioned the ‘Building Blocks’ randomised controlled trial (RCT) from Cardiff University to provide independent evidence on the effectiveness of the FNP programme in improving short term outcomes for young parents and their babies. The trial began in 2009 and the findings which cover the period from pregnancy to the child’s second birthday' were published in October 2015. The FNP described these as “important early findings and add to the evidence the study team have from the US, Netherlands and other early evaluation in England to help improve FNP in England.”

BB: 2-6 - The National Institute of Health Research further funded Cardiff University to undertake a follow up study to examine child and maternal outcomes to age six. This built on the original study to examine the longer-term impact of FNP intervention. Its principal objective was to determine the effectiveness of the FNP programme in reducing objectively measured long-term maltreatment outcomes when compared to usually provided health and social care alone. The main research outcomes were child in need status, child protection registration, referral to social care. Other indicators of programme impact included measures of injuries and ingestions and hospital DNA rates. The study report has been externally peer reviewed and a final version will be published by NIHR in November 2020.

In the BB:2-6 study, Cardiff University followed-up the cohort of mothers and children who took part in the first Building Blocks trial (BB:0-2) by obtaining health and mortality data from NHS Digital, data from Department for Education (DfE) and data from the Department of Health (abortion statistics) and linked with the original trial data.

(iii) Evidence from the Cardiff work and NHS Digital supplied data to date

The original Building Blocks trial (BB:0-2) provided evidence for the short-term effectiveness of the programme (up to 2 years after birth). The Building Blocks: 2-6 (BB:2-6) study has now provided evidence for the medium-term effectiveness and costs of one of the most promising early intervention programmes for reducing risk of child maltreatment in a targeted vulnerable population. Specifically, data requested from NHS Digital provided the basis for key study outcomes which are indicators of maltreatment. Both studies have provided evidence which has informed policy decision-making at both national and local level about whether to continue implementing the programme and also changes to programme content, format and delivery.

(iv) Newly funded work 2019/20:

This new request reflects the receipt of additional funding to analyse the existing pseudonymised study data already held in the data safe haven (which includes NHS Digital supplied data). The newly funded analyses will explore the mechanisms by which specialist home visiting may have its effect for recipient families. Two funders (Nuffield Foundation, European Research Council (ERC)) have provided resource to support the two separate analyses both of which will utilise the same existing data set.

Proposed analyses funded by ERC and Nuffield Trust:

The newly funded analyses will explore the mechanisms by which specialist home visiting may have its effect for recipient families. The analyses to date have determined the impact of the home visiting intervention upon a wide range of family outcomes. These range from the antenatal period through to early in children’s school life (i.e. at key stage 1). The study team have explored how home visiting has benefited some families but been less effective for others. The study team have also assessed the additional benefit that receiving more home visits has had for some of the more important outcomes that have been assessed. The study team have explored the perceptions of both mothers and family nurses (i.e. the professionals who deliver home visits to families) about how the home visiting may exert its effect (and what may be a barrier to its effectiveness). The study team have explored how some outcomes (such as children being designated as In Need by local departments of children’s services) are influenced by a range of potential risk factors (for example, attributes of the mother and child).

The new analysis will take an econometric approach to explore how the benefits of the home visiting intervention are produced. It will explore the mechanisms through which the home visiting intervention is hypothesised to produce benefits (for example, whether expected changes in maternal behaviour occur and whether these then lead to other improvements). It will explore how characteristics of nurses plays any part in observed effects (for example, whether some nurses are associated with more or less improvement. This may be due to differences in clinical experience or training, for example). It will explore further how home visiting dose and quality may be linked to differential family benefits (visit-level data available for each mother in receipt of specialist home-visiting provides detail on how many visits were delivered, their duration and the content addressed using the scheme’s standard monitoring form). Finally, it will also assess how reported use of other public sector services may also have an influence. The existing trial cohort data (including that derived from the NHS via NHS Digital) will be analysed using state-of-the-art economics methods, benefiting from the input of the lead investigator who has secured the additional funding. The analysis will be able to model dynamically the study data to establish more clearly than has been possible previously how the home visiting programme produces benefits for families.

These two analyses (Nuffield and ERC) will both use the existing pseudonymised data set. The first (Nuffield), will involve two similar study cohorts being assessed in the new analyses (the other being from a study in Germany which implemented a similar intervention). The analyses for the two cohorts will be run in parallel (i.e. the data will remain where currently located) but similar research questions will be asked of the two study datasets. No UK data currently held by Cardiff as data controller will be shared or linked to the German data. Only results will be compared when interpreting the outputs from the two analyses. The second funded analysis (ERC), will involve a broader range of data drawn from a variety of sources these will include: distance from / price of / availability of goods and services for children (e.g. price of toys, distance from GP/parks, food prices); and prices of cigarettes, alcohol and local wages. Like the Nuffield funded work, the ERC analyses will involve data from the Building Blocks trial cohort being analysed separately from any other project data but will share a common underlying research question and specialist economics methods. For the analysis of the Building Blocks dataset more detailed exploration of (non-NHS) trial data based on existing post code will be used to determine the role of local context (including policies) upon family outcomes, no attempt will made to identify or link the data.

The two new project grants are led by a member of staff at UCL and the analyses will be undertaken by the research fellow and themselves, both of whom are substantive employees of UCL and hold honorary titles with Cardiff University for the duration of the studies. Access will be as described above, and access will be approved by the study lead at Cardiff University. All analyses will be reviewed and approved by the study lead at Cardiff University. This study lead is the chief investigator and is costed into both grants to provide these approvals and oversee all outputs from the additionally funded work. A statistician based in Cardiff and currently approved to access the cohort dataset will have responsibility to review the statistical analysis plan for both Nuffield and ERC-funded studies.

Cardiff University was the Data Controller (and sponsor) of the original study and Swansea University (and Cardiff University) were Data Processors. This new application will also include UCL as a joint controller and processor. The additional funded work is funded by both the European Research Council and Nuffield Trust. Neither body may make decisions related to how the data are processed and will not have access to the data. The Chair of the Information Governance Review Panel at SAIL has confirmed that as the data being accessed in relation to the newly funded work are appropriately anonymised, no further ethical review is required.

Cardiff University

Article 6:1(e):This project is a task in the public interest because it was commissioned by the Department of Health to evaluate the impact of home-visiting interventions on child maltreatment.

Article 9:2(j):This is scientific research which uses only the data required to answer these important research aims, using a data safe haven to protect the data and outputs this research will directly influence policy making regarding home visiting programmes to benefit the UK public.

University College London

Article 6(1)(e) of the General Data Protection Regulations (GDPR), i.e. “a task carried out in the public interest”. It also falls under Article 9(2)(j), “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes”.

(v) Clarification about data subjects

The data subjects were 1645 women (and their first-born child(ren)) who met eligibility criteria for participation in the Building Blocks trial of the Family Nurse Partnership (FNP) and were nulliparous (a woman who has never given birth either by choice or for any other reason. This term also applies to women who have given birth to a stillborn baby, or a baby who was otherwise not able to survive outside the womb) women aged 19 or under, living in one of 18 local authority FNP catchment areas in England who were recruited by 24+6 weeks gestation, had conversational level of English and were able to consent to research.

Women were recruited by locally-based research professionals usually employed by local NHS organisations following identification through NHS maternity units. Women provided their written informed consent to participate including for data in their administrative health records to be provided to the research team.

Relevant cohort data provided for trial by NHS Digital were Inpatient, Outpatient, A&E datasets and used to follow-up mothers recruited into the study and their babies, up until the baby’s second birthday. These datasets were the main source for two of the primary outcomes (and several secondary outcomes).

The BB:0-2 trial began in 2009 and the findings which cover the period from pregnancy to the child’s second birthday' were published in October 2015.

The National Institute of Health Research funded BB:2-6 study follow up study examined child outcomes to age six, building on the original study examining the longer term impact of FNP intervention. A subsequent application for data from NHS Digital (DARS-NIC-333498-D1K7G) permitted collection of the same health data for an additional four years, until the mother’s first child(ren) was aged six years old. As identifiable data were required to enable linkage of the original trial cohort data to these new records, section 251 approval was given.

The Building Blocks study originally involved a lay group who advised on aspects of trial delivery and provided input into the design and setup of the study. An independent group of young people also provided advice to the research team and a lay perspective on the general management and delivery of the project and in particular the preparation of the outputs from the study.

The results will be of relevance to many different audiences: policymakers at the Department for Education (DfE) and at Department for Health and Social Care (DHSC), and at Public Health England (PHE) in England; at the “National Centre on Early Prevention” (Nationales Zentrum Frühe Hilfen, NZFH), the Ministry for Social Affairs, Health, Women and Family in the German Republic of Saarland and the Federal Ministry of Family Affairs, Senior Citizens, Women and Youth in Germany; the National Health Service (NHS) in England; think tanks; local authorities; practitioners; advocacy groups; media and commentators; and the academic community across several disciplines, ranging from economics to psychology and child development.

The main academic project outputs will be at least two journal articles (one for each study analysis). For the two main publications the study team will target two top economics journals. Upon project completion and in adherence with the publication plan, the study team will consider submitting specific findings for publication in child development or public health journals, to facilitate dissemination to a wider audience. The publication of the report will be advertised through a press release, and the study team will also organize an end-of-project workshop, where academics, practitioners and representatives from FNP, DfE, DHSC, PHE and NHS will be invited to discuss the implications of the findings. To make sure this will reach out to the relevant policy circles, the study team will exploit the fact that the Principal investigator is a Trustee of the Foundation Years Information and Research Group. The Group devoted its yearly seminar series in 2016/2017 to the FNP, and visited the Ministry for Social Affairs, Health, Women and Family in the German Republic of Saarland to study their home visiting programmes in January 2018.

All access for analysis is to pseudonymised data, no identifiable data will be accessed. Published results will only contain aggregated data with small numbers suppressed. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Initial (main) academic outputs will be expected to be available by end 2021. Secondary outputs will be available by Summer 2022.

The original Building Blocks trial (BB:0-2) provided evidence for the short-term effectiveness of the programme (up to 2 years after birth). The Building Blocks: 2-6 (BB:2-6) study has now provided evidence for the medium-term effectiveness and costs of one of the most promising early intervention programmes for reducing risk of child maltreatment in a targeted vulnerable population. Both studies have provided evidence which has informed policy decision-making at both national and local level about whether to continue implementing the programme and also changes to programme content, format and delivery.