An interventional study of Nurse-Family Partnership in Maternal Behavior, Injuries and Violence, sponsored by Oslo Metropolitan University. Recruiting at 5 sites in Norway. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Oslo Metropolitan University · Not applicable, Interventional, and Supportive care
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.
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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 700 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Oslo Metropolitan University is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
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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
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 group members have access to the standard of care and whatever other programs and services are available in the community.
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
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
Time frame: 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
Time frame: at 12 and 24 months postpartum
Child welfare service reports
Total number of reports to the child welfare service due to violence since birth
Time frame: 24 months postpartum
Child welfare service measures
Total number of provided measures and care takeovers due to violence since birth
Time frame: 24 months postpartum
Injuries (change is being assessed)
Hospital admissions
Time frame: at delivery, 6, 12 and 24 months postpartum
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 6, 12 and 24 months postpartum
Child Development
Bayley scale of infant development
Time frame: 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
Time frame: baseline, in last trimester, at 6, 12 and 24 months postpartum
Health behaviour (change is being assessed)
Use of tobacco, alcohol, drugs
Time frame: baseline, in last trimester, at 6, 12 and 24 months postpartum
Plan to share: No
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Oslo Metropolitan University