The Mother in Norway Study (MiNS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Injuries; Violence; Maternal Behavior; Mental Health Wellness
• Intervention / Treatment: Behavioral: Nurse-Family Partnership

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 Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Grete Tøge, phd; Phone Number: +47 67 23 81 58; Email: Anne-Grete.Toge@oslomet.no
• Study Contact Backup: Name: Eirin Pedersen, phd; Phone Number: +47 936 36 150; Email: Eirin.Pedersen@oslomet.no

Study Locations

• Norway
  • Bergen, Norway, 5009
    • Recruiting
    • Region Vestland
    • Contact: Elin Kråkenes, Master; Phone Number: +47 40 80 16 11; Email: elin.krakenes@bergen.kommune.no
  • Kristiansand, Norway, 4630
    • Recruiting
    • Region Agder
    • Contact: Marit Sandvik Tønnessen, Bachelor; Phone Number: +47 91 78 27 24; Email: Marit.Sandvik.Tonnessen@kristiansand.kommune.no
  • Oslo, Norway, 0188
    • Recruiting
    • Region Oslo
    • Contact: Heidi Duesund Hansen, Bachelor; Phone Number: +4748277683; Email: Heidi.hansen@bgo.oslo.kommune.no
  • Sandnes, Norway, 4307
    • Recruiting
    • Region Rogaland
    • Contact: Grete Thilo Olsen-Hagen, Bachelor; Phone Number: +47 48 25 87 55; Email: grete.thilo.olsen-hagen@sandnes.kommune.no
  • Trondheim, Norway, 7004
    • Recruiting
    • Region Trøndelag
    • Contact: Monica Wold Gustafson, Master; Phone Number: +47 913 43 062; Email: Monica-wold.gustafson@trondheim.kommune.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control group members have access to the standard of care and whatever other programs and services are available in the community.
Experimental: Treatment-NFP; 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; 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

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

Collaborators and Investigators

• Sponsor: Oslo Metropolitan University
• Collaborators: University of Oslo; Norwegian Institute of Public Health; Norwegian Center for Violence and Traumatic Stress Studies; The Norwegian Directorate for Children, Youth and Family Affairs; Regional centre for children and youth mental health and welfare
• Investigators: Principal Investigator: Anne Grete Tøge, phd, Oslo Metropolitan University; Principal Investigator: Eirin Pedersen, phd, Oslo Metropolitan University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2042

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NFP-202862

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No