The Mother in Norway Study

Not Applicable

Recruiting

• Conditions: Injuries; Violence; Maternal Behavior; Mental Health Wellness
• Interventions: Behavioral: Nurse-Family Partnership

• Registration Number: NCT05895604
• Lead Sponsor: Oslo Metropolitan University

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.

Study Timeline

• Study First Submitted: 2023-04-17
• Study First Submitted QC: 2023-05-31
• Study Start: 2023-06-01
• Study First Posted: 2023-06-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01
• Primary Completion: 2027-12-31
• Study Completion: 2042-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment-NFP	Nurse-Family Partnership	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).

Primary Outcome Measures

Name	Time	Method
Domestic violence (change is being assessed)	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 maltreatment (change is being assessed)	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 reports	24 months postpartum	Total number of reports to the child welfare service due to violence since birth
Child welfare service measures	24 months postpartum	Total number of provided measures and care takeovers due to violence since birth
Injuries (change is being assessed)	at delivery, 6, 12 and 24 months postpartum	Hospital admissions

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Region Rogaland; 🇳🇴 Sandnes, Norway

Region Vestland; 🇳🇴 Bergen, Norway

Region Agder; 🇳🇴 Kristiansand, Norway

Region Oslo; 🇳🇴 Oslo, Norway

Region Trøndelag; 🇳🇴 Trondheim, Norway