The Mother in Norway Study

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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 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.

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

Conditions
-----------------
Injuries, Maternal Behavior, Violence, Mental Health Wellness

Intervention / Treatment
-----------------
* Behavioral: Nurse-Family Partnership


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment-NFP<br>NFP is a prenatal and infancy home visiting program for vulnerable first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, guiding the mothers-to-be on different aspects of the parental role and offer practical and emotional support. The nurses continue visiting regularly until the child is two years old (up to 64 visits in total). | Behavioral: Nurse-Family Partnership<br>* 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<br>|
| No Intervention: Control<br>Control group members have access to the standard of care and whatever other programs and services are available in the community. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Domestic violence (change is being assessed) | Composite Abuse Scale - Revised Short Form (CASr-SF). Items are scored on a scale ranging from 1-5, where higher scores indicate worse outcomes | baseline, in last trimester, at 6, 12 and 24 months postpartum | 
| Child maltreatment (change is being assessed) | Brief Child Abuse Potential Inventory (BCAPI). Items are scored on a dichotomous range (agree/disagree), where higher scores indicate better outcomes | at 12 and 24 months postpartum | 
| Child welfare service reports | Total number of reports to the child welfare service due to violence since birth | 24 months postpartum | 
| Child welfare service measures | Total number of provided measures and care takeovers due to violence since birth | 24 months postpartum | 
| Injuries (change is being assessed) | Hospital admissions | at delivery, 6, 12 and 24 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental skills (change is being assessed) | Parenting Sense of Competence Scale (PSOC). Items are scored on a scale ranging from 1-6, where higher scores indicate better outcomes | at 6, 12 and 24 months postpartum | 
| Interaction between mother and child | Emotional Availability Scale. Items are scored on a scale ranging from 1-7, where higher scores indicate better outcomes | at 12 months postpartum | 
| Self-Efficacy (change is being assessed) | General Self-Efficacy Scale (GSE). Items are scored on a scale ranging from 1-4, where higher scores indicate better outcomes | at baseline, and at 6, 12 and 24 months postpartum | 
| Parental Locus of Control (change is being assessed) | Parental locus of control (PLOC). Items are scored on a scale ranging from 1-5, where lower scores indicating internal control and higher scores indicating external control | at 6, 12 and 24 months postpartum | 
| Child Development | Bayley scale of infant development | at 24 months postpartum | 
| Health-related Quality of Life (change is being assessed) | EQ-5D (the EuroQol Instrument), Items are scored on a scale ranging from 1-5, where higher scores indicate worse outcomes | baseline, in last trimester, at 6, 12 and 24 months postpartum | 
| Health behaviour (change is being assessed) | Use of tobacco, alcohol, drugs | baseline, in last trimester, at 6, 12 and 24 months postpartum |