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NCT Number: NCT05895604

The Mother in Norway Study

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.

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Key information

Conditions

Maternal Behavior Injuries Mental Health Wellness Violence Wounds and Injuries

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Region Vestland, Bergen, Norway

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About this study

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 consists of 700 mothers to be enrolled over 3 years (June 2023-2026). Each participant will be individually randomized with a 50 percent probability of being assigned to the treatment group, and a 50 percent probability of being assigned to the control group. NFP services will be provided to those in the treatment group through the child's second birthday (2025-2029). 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Domestic violence (change is being assessed)

    Time frame: 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

  2. Child maltreatment (change is being assessed)

    Time frame: 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

  3. Child welfare service reports

    Time frame: 24 months postpartum

    Total number of reports to the child welfare service due to violence since birth

  4. Child welfare service measures

    Time frame: 24 months postpartum

    Total number of provided measures and care takeovers due to violence since birth

  5. Injuries (change is being assessed)

    Time frame: at delivery, 6, 12 and 24 months postpartum

    Hospital admissions

Secondary outcomes

  1. Parental skills (change is being assessed)

    Time frame: 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

  2. Interaction between mother and child

    Time frame: at 12 months postpartum

    Emotional Availability Scale. Items are scored on a scale ranging from 1-7, where higher scores indicate better outcomes

  3. Self-Efficacy (change is being assessed)

    Time frame: 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

  4. Parental Locus of Control (change is being assessed)

    Time frame: 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

  5. Child Development

    Time frame: at 24 months postpartum

    Bayley scale of infant development

  6. Health-related Quality of Life (change is being assessed)

    Time frame: 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

  7. Health behaviour (change is being assessed)

    Time frame: baseline, in last trimester, at 6, 12 and 24 months postpartum

    Use of tobacco, alcohol, drugs

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Grete Tøge, phd

CONTACT

[email protected]

+47 67 23 81 58

Eirin Pedersen, phd

CONTACT

[email protected]

+47 936 36 150

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MiNS

Important dates

Study start
2023
Primary completion
2028
Study completion
2042
First posted
Jun 8, 2023
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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