Parenting, child development and primary care—‘Crescer em Grande!’ intervention (CeG!) based on the Touchpoints approach: a cluster-randomised controlled trial protocol

INTRODUCTION: Despite support for parenting being already recognised as a priority, there remains a paucity of evidence on how to facilitate its adoption in regular visits of maternal and child health primary care (PC). We describe the protocol for a study to assess the effect of an innovative universal Touchpoints-based intervention—‘Crescer em Grande!’ (CeG!) - when supporting the process of transition to parenthood and early infancy, at multiple PC units. METHODS AND ANALYSIS: A cluster-randomised trial will be conducted in 12 PC units (clusters) from the Lisbon metropolitan area, Portugal. Participants will be a minimum of three family physicians and one nurse/unit, as well as 216 expecting parents and future babies until 18 months who are using the PC services. Sites will be randomised to either the CeG! or usual care. The CeG! will consist of: (1) the integration of the Touchpoints approach in PC maternal and well-child visits, with the support of 28 leaflets for parents to file in a folder; plus (2) training for PC providers on how to perform the CeG! into existing practice. Parents will be required to fill in questionnaires at point throughout their child’s 18-month, mostly online. The primary outcome will be the self-perception of parental competence (Parenting Sense of Competence Scale). Other outcomes include: family functioning, couple dynamics, mental health, well-being/quality of life, psychological experience of pregnancy, attachment, child development. Acceptability, satisfaction and feasibility of CeG! will also be obtained from providers’ and parents’ perspectives. Costs associated with delivering the CeG! will be calculated. Study analyses will be under the principle of intention-to-treat. ETHICS AND DISSEMINATION: Approval was obtained from the Ethics Committee of the Regional Health Administration. The results will be shared with participants and disseminated via peer-reviewed published papers, presentations at scientific and professional conferences. TRIAL REGISTRATION NUMBER: ISRCTN90692907