{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T11:54:54Z","timestamp":1765886094481,"version":"3.48.0"},"reference-count":31,"publisher":"BMJ","issue":"7","funder":[{"DOI":"10.13039\/501100001921","name":"Public Health Research Programme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001921","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2017,5,3]]},"published-print":{"date-parts":[[2017,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      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 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"23019866\">ISRCTN23019866<\/jats:ext-link>\n                      ) 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\u20136 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\u2019s impact on preventing child maltreatment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We have developed a bespoke model of data linkage whereby outcome data for the trial cohort will be retrieved by linked anonymous data abstraction from NHS Digital, Office for National Statistics and the Department for Education\u2019s National Pupil Database. Participants will be given reasonable opportunity to opt out of this study prior to data transfer. The information centres will match participants to the information held in their databases using standard identifiers and send extracts to a third-party safe haven. The study will have 80% power to detect a 4% difference (4%vs8%) for the binary primary outcome of child in need status (from birth to key stage 1) at a two-sided 5% alpha level by following up 602 children in each trial arm. Analysis will be by intention to treat using logistic multilevel modelling. A cost-and-consequences analysis will extend the time frame of the economic analysis from the original trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study protocol has been approved by the National Health Service Wales Research Ethics Committee and the Health Research Authority\u2019s Confidentiality Advisory Group. Methods of innovative study design and findings will be disseminated through peer-reviewed journals and conferences; results will be of interest to clinical and policy stakeholders in the UK.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ISRCTN23019866.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2016-015728","type":"journal-article","created":{"date-parts":[[2017,7,14]],"date-time":"2017-07-14T20:10:17Z","timestamp":1500063017000},"page":"e015728","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Assessing the medium-term impact of a home-visiting programme on child maltreatment in England: protocol for a routine data linkage study"],"prefix":"10.1136","volume":"7","clinical-trial-number":[{"clinical-trial-number":"isrctn23019866","registry":"10.18810\/isrctn"},{"clinical-trial-number":"isrctn23019866","registry":"10.18810\/isrctn"}],"author":[{"given":"Fiona V","family":"Lugg-Widger","sequence":"first","affiliation":[{"name":"South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rebecca","family":"Cannings-John","sequence":"additional","affiliation":[{"name":"South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sue","family":"Channon","sequence":"additional","affiliation":[{"name":"South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah","family":"Fitzsimmons","sequence":"additional","affiliation":[{"name":"Swansea Centre for Health Economics, Swansea University, Swansea, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kerenza","family":"Hood","sequence":"additional","affiliation":[{"name":"South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kerina H","family":"Jones","sequence":"additional","affiliation":[{"name":"College of Medicine, Swansea University, Swansea, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison","family":"Kemp","sequence":"additional","affiliation":[{"name":"Division of Population Medicine, Cardiff University School of Medicine, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joyce","family":"Kenkre","sequence":"additional","affiliation":[{"name":"Faculty of Life Sciences and Education, University of South Wales, Pontypridd, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mirella","family":"Longo","sequence":"additional","affiliation":[{"name":"Marie Curie Palliative Care Research Centre, Cardiff University School of Medicine, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kirsten","family":"McEwan","sequence":"additional","affiliation":[{"name":"Department of Psychology, University of Derby, Derby, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gwenllian","family":"Moody","sequence":"additional","affiliation":[{"name":"South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eleri","family":"Owen-Jones","sequence":"additional","affiliation":[{"name":"South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia","family":"Sanders","sequence":"additional","affiliation":[{"name":"School of Healthcare Sciences, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeremy","family":"Segrott","sequence":"additional","affiliation":[{"name":"South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK"},{"name":"DECIPHer Centre, Cardiff School of Social Sciences, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Robling","sequence":"additional","affiliation":[{"name":"South East Wales Trials Unit, Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2017,7,13]]},"reference":[{"key":"2025121300162538000_7.7.e015728.1","unstructured":"A guide to inter-agency working to safeguard and promote the welfare of children. 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