The Mother in Norway Study

NCT05895604 | Recruiting

• 1 other identifier: NFP-202862
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Maternal Behavior; Injuries; Violence; Mental Health Wellness

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Parental skills (change is being assessed)

  at 6, 12 and 24 months postpartum

• Interaction between mother and child

  at 12 months postpartum

• Self-Efficacy (change is being assessed)

  at baseline, and at 6, 12 and 24 months postpartum

• Parental Locus of Control (change is being assessed)

  at 6, 12 and 24 months postpartum

• Child Development

  at 24 months postpartum

Study Arms (2)

Treatment-NFP

EXPERIMENTAL

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

Control

NO INTERVENTION

Control group members have access to the standard of care and whatever other programs and services are available in the community.

Interventions

Nurse-Family Partnership BEHAVIORAL

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

Treatment-NFP

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• University of Oslo: collaborator
• Norwegian Institute of Public Health: collaborator
• The Norwegian Directorate for Children, Youth and Family Affairs: collaborator
• Norwegian Center for Violence and Traumatic Stress Studies: collaborator
• Regional centre for children and youth mental health and welfare: collaborator

Study Sites (5)

Region Vestland

Bergen, Bergen, 5009, Norway

RECRUITING

Region Agder

Kristiansand, Kristiansand, 4630, Norway

RECRUITING

Region Rogaland

Sandnes, Sandnes, 4307, Norway

RECRUITING

Region Trøndelag

Trondheim, Trondheim, 7004, Norway

RECRUITING

Region Oslo

Oslo, 0188, Norway

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Anne Grete Tøge, phd

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

• Eirin Pedersen, phd

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Grete Tøge, phd

CONTACT

+47 67 23 81 58; Anne-Grete.Toge@oslomet.no

Eirin Pedersen, phd

CONTACT

+47 936 36 150; Eirin.Pedersen@oslomet.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2042
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)