Actively Recruiting

Phase Not Applicable
Age: 16Years +
FEMALE
Healthy Volunteers
ID05895604

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

Led by Oslo Metropolitan University · Updated on 2025-08-11

700

Participants Needed

5

Research Sites

730 weeks

Total Duration

On this page

Sponsors

O

Oslo Metropolitan University

Lead Sponsor

U

University of Oslo

Collaborating Sponsor

AI-Summary

What this Trial Is About

The Norwegian government is studying the Nurse Family Partnership (NFP) program to help prevent child abuse and reduce social inequality among vulnerable first-time mothers. This research is a randomized controlled trial involving 700 mothers enrolled over three years. The study aims to compare outcomes between mothers receiving NFP services and those receiving standard care, focusing on violence toward mothers and children as the primary outcome. The program's impact on various health-related factors will also be assessed using administrative data, alongside cost-effectiveness analyses to evaluate the value and delivery of NFP services. Participants in the treatment group will receive the NFP intervention, which consists of regular home visits by registered nurses starting early in pregnancy and continuing until the child turns two years old. These visits provide prenatal guidance, parenting support, and emotional assistance, potentially totaling up to 64 visits. The control group will have access to the usual community care and services without additional NFP visits. Enrollment occurs between 2023 and 2026, with the intervention period lasting through 2029 for those in the treatment group. Mothers will complete questionnaires during the last trimester of pregnancy and when their child is 6, 12, and 24 months old, assessing partner violence, parenting skills, coping, control, and child development. At 24 months, trained staff will conduct developmental and language observations using the Bayley test. The study also collects health and social outcome data from administrative records. Researchers will analyze changes in domestic violence, child maltreatment, injuries, parental skills, self-efficacy, and quality of life, with blinded assessments to estimate the effects of NFP compared to standard care.

CONDITIONS

Brief Title

The Mother in Norway Study

Who Can Participate

Age: 16Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • No previous live births
  • Currently pregnant
  • Gestation period less than 28 weeks at time of recruitment
  • Live within an area serviced by a Nurse Family Partnership Implementing Agency
  • Not currently enrolled in the study
  • Professionals are concerned about the pregnancy or impending parenthood
Not Eligible

You will not qualify if you...

  • Women who have had a previous live birth
  • Women who are not currently pregnant
  • Women who are past their 28th week of gestation at time of recruitment
  • Women who live outside of an area serviced by a Nurse Family Partnership Implementing Agency
  • Women who are currently enrolled in the study
  • Professionals are not concerned about the pregnancy or impending parenthood

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - From early pregnancy until the child’s second birthday (up to 2 years postpartum)

Participants in the treatment group receive Nurse-Family Partnership services consisting of prenatal and infancy home visits by registered nurses. These visits provide guidance on parenting and practical and emotional support, starting early in pregnancy and continuing until the child is two years old.

Regular home visits totaling up to 64 visits

Monitoring

Duration - From last trimester of pregnancy through 24 months postpartum

Participants complete questionnaires in the last trimester of pregnancy and when the child is 6, 12, and 24 months old to assess partner violence, parenting skills, coping, control, and child development. At 24 months, child development and language are further assessed by health station staff using the Bayley observation test. Administrative data on health and related outcomes are also collected.

4 questionnaire assessments plus 1 developmental assessment at 24 months

Trial Site Locations

Total: 5 locations

1

Region Vestland

Bergen, Bergen, Norway, 5009

Actively Recruiting

2

Region Agder

Kristiansand, Kristiansand, Norway, 4630

Actively Recruiting

3

Region Rogaland

Sandnes, Sandnes, Norway, 4307

Actively Recruiting

4

Region Trøndelag

Trondheim, Trondheim, Norway, 7004

Actively Recruiting

5

Region Oslo

Oslo, Norway, 0188

Actively Recruiting

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Research Team

A

Anne Grete Tøge, phd

E

Eirin Pedersen, phd

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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