The Mother in Norway Study - A Randomised Trial of Nurse-Family Partnership (NFP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 10
- 主要终点
- Domestic violence (change is being assessed)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Domestic violence (change is being assessed)
时间窗: baseline, in last trimester, at 6, 12 and 24 months postpartum
Composite Abuse Scale - Revised Short Form (CASr-SF). Items are scored on a scale ranging from 1-5, where higher scores indicate worse outcomes
Child welfare service reports
时间窗: 24 months postpartum
Total number of reports to the child welfare service due to violence since birth
Child maltreatment (change is being assessed)
时间窗: at 12 and 24 months postpartum
Brief Child Abuse Potential Inventory (BCAPI). Items are scored on a dichotomous range (agree/disagree), where higher scores indicate better outcomes
Child welfare service measures
时间窗: 24 months postpartum
Total number of provided measures and care takeovers due to violence since birth
Injuries (change is being assessed)
时间窗: at delivery, 6, 12 and 24 months postpartum
Hospital admissions
次要结局
- Parental skills (change is being assessed)(at 6, 12 and 24 months postpartum)
- Health behaviour (change is being assessed)(baseline, in last trimester, at 6, 12 and 24 months postpartum)
- Self-Efficacy (change is being assessed)(at baseline, and at 6, 12 and 24 months postpartum)
- Child Development(at 24 months postpartum)
- Interaction between mother and child(at 12 months postpartum)
- Parental Locus of Control (change is being assessed)(at 6, 12 and 24 months postpartum)
- Health-related Quality of Life (change is being assessed)(baseline, in last trimester, at 6, 12 and 24 months postpartum)