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We describe the protocol for a study to assess the effect of an\n innovative universal Touchpoints-based intervention\u2014\u2018Crescer em Grande!\u2019\n (CeG!) - when supporting the process of transition to parenthood and\n early infancy, at multiple PC units.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n A cluster-randomised trial will be conducted in 12 PC units\n (clusters) from the Lisbon metropolitan area, Portugal. Participants\n will be a minimum of three family physicians and one nurse\/unit, as well\n as 216 expecting parents and future babies until 18 months who are using\n the PC services. Sites will be randomised to either the CeG! or usual\n care. The CeG! will consist of: (1) the integration of the Touchpoints\n approach in PC maternal and well-child visits, with the support of 28\n leaflets for parents to file in a folder; plus (2) training for PC\n providers on how to perform the CeG! into existing practice. Parents\n will be required to fill in questionnaires at point throughout their\n child\u2019s 18-month, mostly online. The primary outcome will be the\n self-perception of parental competence (Parenting Sense of Competence\n Scale). Other outcomes include: family functioning, couple dynamics,\n mental health, well-being\/quality of life, psychological experience of\n pregnancy, attachment, child development. Acceptability, satisfaction\n and feasibility of CeG! will also be obtained from providers\u2019 and\n parents\u2019 perspectives. Costs associated with delivering the CeG! will be\n calculated. Study analyses will be under the principle of\n intention-to-treat.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n Approval was obtained from the Ethics Committee of the Regional\n Health Administration. The results will be shared with participants and\n disseminated via peer-reviewed published papers, presentations at\n scientific and professional conferences.<\/jats:p>\n <\/jats:sec>\n \n Trial registration number<\/jats:title>\n NCT90692907<\/jats:ext-link><\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-042043","type":"journal-article","created":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T14:48:37Z","timestamp":1667573317000},"page":"e042043","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Parenting, child development and primary care\u2014\u2018Crescer em Grande!\u2019\n intervention (CeG!) based on the Touchpoints approach: a cluster-randomised\n controlled trial protocol"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct90692907","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7312-2178","authenticated-orcid":false,"given":"Filipa","family":"Fareleira","sequence":"first","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2223-2000","authenticated-orcid":false,"given":"Maria Raul","family":"Xavier","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1185-2500","authenticated-orcid":false,"given":"Julia","family":"Velte","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1199-2220","authenticated-orcid":false,"given":"Andreia","family":"Teixeira","sequence":"additional","affiliation":[]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8561-5167","authenticated-orcid":false,"given":"Carlos","family":"Martins","sequence":"additional","affiliation":[]}],"member":"239","published-online":{"date-parts":[[2021,5,11]]},"reference":[{"key":"2022110304304327000_11.5.e042043.1","unstructured":"OECD . 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