The Mother in Norway Study

Официальное название

The Mother in Norway Study - A Randomised Trial of Nurse-Family Partnership (NFP)

Обзор

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 three 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.

Подробное описание

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 consists of 700 mothers to be enrolled over 3 years (June 2023-2026). Each participant will be individually randomized with a 50 percent probability of being assigned to the treatment group, and a 50 percent probability of being assigned to the control group. NFP services will be provided to those in the treatment group through the child's second birthday (2025-2029). 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 health- and 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.

Вмешательства

• Поведенческое Nurse-Family Partnership
  Nurse-Family Partnership is a prenatal and infancy home visiting program providing regular visits to first-time mothers until the child is two years old

Первичные конечные точки

• Domestic violence (change is being assessed) [Срок оценки: baseline, in last trimester, at 6, 12 and 24 months postpartum]
• Child maltreatment (change is being assessed) [Срок оценки: at 12 and 24 months postpartum]
• Child welfare service reports [Срок оценки: 24 months postpartum]
• Child welfare service measures [Срок оценки: 24 months postpartum]
• Injuries (change is being assessed) [Срок оценки: at delivery, 6, 12 and 24 months postpartum]

Вторичные конечные точки (7)

• Parental skills (change is being assessed) [Срок оценки: at 6, 12 and 24 months postpartum]
• Interaction between mother and child [Срок оценки: at 12 months postpartum]
• Self-Efficacy (change is being assessed) [Срок оценки: at baseline, and at 6, 12 and 24 months postpartum]
• Parental Locus of Control (change is being assessed) [Срок оценки: at 6, 12 and 24 months postpartum]
• Child Development [Срок оценки: at 24 months postpartum]
• Health-related Quality of Life (change is being assessed) [Срок оценки: baseline, in last trimester, at 6, 12 and 24 months postpartum]
• Health behaviour (change is being assessed) [Срок оценки: baseline, in last trimester, at 6, 12 and 24 months postpartum]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Норвегия · 5 центров

• Region Vestland — Bergen
• Region Agder — Kristiansand
• Region Rogaland — Sandnes
• Region Trøndelag — Trondheim
• Region Oslo — Oslo

Идентификаторы

NCT: NCT05895604 · NFP-202862

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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