Clinical trial NCT05895604: The Mother in Norway Study
Official title: The Mother in Norway Study - A Randomised Trial of Nurse-Family Partnership (NFP)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Behavior
Injuries
Violence
Mental Health Wellness
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian Institute of Public Health
name: The Norwegian Directorate for Children, Youth and Family Affairs
name: Norwegian Center for Violence and Traumatic Stress Studies
name: Regional centre for children and youth mental health and welfare
First posted: 2023-06-08
Enrollment: 700
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 two 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.

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 is 700 mothers total (350 in the treatment group and 350 in the control group) to be enrolled over 2 years (June 2023 -2025), with NFP services delivered to the treatment group through the children's second birthday (2025-2028). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Domestic violence (change is being assessed)
timeFrame: baseline, in last trimester, at 6, 12 and 24 months postpartum
measure: Child maltreatment (change is being assessed)
timeFrame: at 12 and 24 months postpartum
measure: Child welfare service reports
timeFrame: 24 months postpartum
measure: Child welfare service measures
timeFrame: 24 months postpartum
measure: Injuries (change is being assessed)
timeFrame: at delivery, 6, 12 and 24 months postpartum
Secondary outcomes:
measure: Parental skills (change is being assessed)
timeFrame: at 6, 12 and 24 months postpartum
measure: Interaction between mother and child
timeFrame: at 12 months postpartum
measure: Self-Efficacy (change is being assessed)
timeFrame: at baseline, and at 6, 12 and 24 months postpartum
measure: Parental Locus of Control (change is being assessed)
timeFrame: at 6, 12 and 24 months postpartum
measure: Child Development
timeFrame: at 24 months postpartum
measure: Health-related Quality of Life (change is being assessed)
timeFrame: baseline, in last trimester, at 6, 12 and 24 months postpartum
measure: Health behaviour (change is being assessed)
timeFrame: baseline, in last trimester, at 6, 12 and 24 months postpartum
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Region Vestland
city: Kristiansand
country: Norway
facility: Region Agder
city: Oslo
country: Norway
facility: Region Oslo
city: Sandnes
country: Norway
facility: Region Rogaland
city: Trondheim
country: Norway
facility: Region Trøndelag
Study officials:
affiliation: Oslo Metropolitan University
name: Anne Grete Tøge, phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo Metropolitan University
name: Eirin Pedersen, phd
role: PRINCIPAL_INVESTIGATOR
References: