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The Mother in Norway Study (MiNS): study protocol for a randomized controlled trial evaluating the effectiveness of
Eirin Pedersen1, Joakim Finne1, Ira Malmberg-Heimonen2
1The Work Research Institute, OsloMet - Oslo Metropolitan University, Oslo, Norway.
Aims:
Since 2015, the Norwegian government has prioritized early prevention of social inequities and child maltreatment. As part of this, it has commissioned an evaluation of the Nurse-Family Partnership programme (NFP) adapted for Norway. NFP is a manualized, intensive nurse home-visiting programme to support families experiencing disadvantage from early pregnancy until the child is 2 years old.
Methods:
The Mother in Norway Study (MiNS) is a parallel-group randomized controlled trial evaluating the effectiveness of the NFP programme versus standard care in improving maternal and child outcomes. A total of 700 participants is being recruited between 2023 and 2026 at least 12 weeks before their due date, screened for eligibility, and individually randomly assigned (1:1) to standard care alone or NFP plus standard care. Both groups may access usual community services. Primary outcomes are maternal-reported intimate partner violence and child maltreatment risk, assessed at baseline and 24 months postpartum using the Composite Abuse Scale - Revised Short Form (CASr-SF) and the Brief Child Abuse Potential Inventory (BCAPI), respectively. Secondary outcomes include maternal mental health, parenting, child socioemotional development, parent-child interaction, and health-related outcomes assessed through questionnaires and linked administrative data. Analyses will follow the intention to treat principle, with statisticians blinded to allocation. Cost-effectiveness analyses will estimate the cost per quality-adjusted life year (QALY) gained.
Conclusions:
This trial will generate evidence on the effectiveness and cost-effectiveness of the NFP in Norway, inform policymaking for early prevention of child health inequities, and establish a foundation for longer-term follow-up.
