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Maternal BehaviorMiNSNCT05895604

The Mother in Norway Study

A study testing Nurse-Family Partnership in people with Maternal Behavior and Injuries, run by Oslo Metropolitan University at 5 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Maternal Behavior, Injuries, Violence
What is being tested?
Nurse-Family Partnership
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
5 sitesNorway
Study dates
1 Jun 2023to 31 Dec 2042
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

5 sites in 1 country

Norway5 sites, 5 recruiting

  • Region Vestland

    Bergen, Bergen, 5009

    Elin Kråkenes, Master, +47 40 80 16 11, elin.krakenes@bergen.kommune.no

    Recruiting

  • Region Agder

    Kristiansand, Kristiansand, 4630

    Marit Sandvik Tønnessen, Bachelor, +47 91 78 27 24, Marit.Sandvik.Tonnessen@kristiansand.kommune.no

    Recruiting

  • Region Oslo

    Oslo, 0188

    Heidi Duesund Hansen, Bachelor, +4748277683, Heidi.hansen@bgo.oslo.kommune.no

    Recruiting

  • Region Rogaland

    Sandnes, Sandnes, 4307

    Grete Thilo Olsen-Hagen, Bachelor, +47 48 25 87 55, grete.thilo.olsen-hagen@sandnes.kommune.no

    Recruiting

  • Region Trøndelag

    Trondheim, Trondheim, 7004

    Monica Wold Gustafson, Master, +47 913 43 062, Monica-wold.gustafson@trondheim.kommune.no

    Recruiting

Other trials in Norway

About this study

Official title: 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 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.

Read the 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 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.

Being tested
Nurse-Family Partnership
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurse-Family PartnershipBehavioural

    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

Study groups in NCT05895604
Study groupRoleWhat they receive
Treatment-NFPExperimentalNFP 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).
Receives: Behavioral: Nurse-Family Partnership
ControlNo interventionControl group members have access to the standard of care and whatever other programs and services are available in the community.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

    Measured: at 12 and 24 months postpartum

  3. Child welfare service reports

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

    Measured: 24 months postpartum

  4. Child welfare service measures

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

    Measured: 24 months postpartum

  5. Injuries (change is being assessed)

    Hospital admissions

    Measured: at delivery, 6, 12 and 24 months postpartum

Secondary outcomes (7)

  1. 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

    Measured: at 6, 12 and 24 months postpartum

  2. Interaction between mother and child

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

    Measured: at 12 months postpartum

  3. 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

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

  4. 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

    Measured: at 6, 12 and 24 months postpartum

  5. Child Development

    Bayley scale of infant development

    Measured: at 24 months postpartum

  6. 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

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

  7. Health behaviour (change is being assessed)

    Use of tobacco, alcohol, drugs

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2023
  2. Study start1 Jun 2023
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2042 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05895604
Sponsor's protocol ID
NFP-202862
Acronym
MiNS
Status last verified
Aug 2025
First submitted
17 Apr 2023
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nurse-Family Partnership in people with Maternal Behavior and Injuries, run by Oslo Metropolitan University at 5 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne Grete Tøge, phd (+47 67 23 81 58, Anne-Grete.Toge@oslomet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Domestic violence (change is being assessed) (time frame: baseline, in last trimester, at 6, 12 and 24 months postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05895604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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