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The Mother in Norway Study

Recruiting
16 years of age
Female
Phase N/A

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Overview

The Norwegian government is implementing the Nurse Family Partnership program (NFP) to combat child abuse and social inequality. This study will examine NFP with an individually randomized controlled parallel-group trial. The study will enroll 700 mothers over two years, with half receiving NFP services and the other half receiving standard care. The primary outcome is violence towards mothers and their children, assessed through questionnaires and observation tests. The study will also evaluate the program's effects on various health-related outcomes using administrative data. Cost-effectiveness analyses will be conducted to compare NFP to existing services and improve its delivery efficiency.

Description

The Norwegian government has since 2015 been in the process of implementing the Nurse Family Partnership program (NFP) in Norway, as a possibly important part in their strategy to combat child abuse and social inequality. This study employs an individually randomized controlled parallel-group trial where participants are randomly assigned to experimental and control groups. The planned study population is 700 mothers total (350 in the treatment group and 350 in the control group) to be enrolled over 2 years (June 2023 -2025), with NFP services delivered to the treatment group through the children's second birthday (2025-2028). The control group will receive the standard of care and whatever other programs and services are available in the community.

Primary outcome is violence towards first-time mothers and their children. In their last trimester, and when the child is 6, 12 and 24 months old, mothers included in the study will receive a questionnaire assessing perceived partner violence, parenting skills, coping, control, and the child's development and language. At 24 months, staff at health stations will perform the Bayley observation test of the child“s development and language. The study will also utilise administrative data to assess the effects of NFP on a wide range of healthand health related outcomes. All analyses are carried out blinded. The investigators estimate "intention-to-treat" (ITT) effects and per-protocol analysis. Cost-effectiveness analyses will be conducted to compare the value of NFP to existing services, and to improve the efficiency in the delivery of NFP.

Eligibility

Inclusion Criteria: Female; No previous live births; Currently pregnant; Gestation period

        less than 28 weeks (i.e., less than or equal to 27 weeks, 6 days) at time of recruitment;
        Live within an area serviced by a NFP Implementing Agency; Not currently enrolled in the
        study; professionals are concerned about the pregnancy / impending parenthood
        Exclusion Criteria: Women who have had a previous live birth; Women who are not currently
        pregnant; Women who are past their 28th week of gestation (i.e., greater than or equal to
        28 weeks, 0 days) at time of recruitment; Women who live outside of an area serviced by a
        NFP Implementing Agency; Women who are currently enrolled in the study; professionals are
        not concerned about the pregnancy / impending parenthood

Study details

Maternal Behavior, Injuries, Violence, Mental Health Wellness

NCT05895604

Oslo Metropolitan University

25 January 2024

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