The Mother in Norway Study

Violence Clinical Trial

— MiNS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895604
• Other study ID #: NFP-202862
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2042

Study information

• Verified date: October 2023
• Source: Oslo Metropolitan University
• Contact: Anne Grete Tøge, phd
• Phone: +47 67 23 81 58
• Email: Anne-Grete.Toge[@]oslomet.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2042
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Injuries
• Maternal Behavior
• Mental Health Wellness
• Violence

Intervention

Behavioral:
• Nurse-Family Partnership
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

Locations

Country	Name	City	State
Norway	Region Vestland	Bergen
Norway	Region Agder	Kristiansand
Norway	Region Oslo	Oslo
Norway	Region Rogaland	Sandnes
Norway	Region Trøndelag	Trondheim

Sponsors (6)

Lead Sponsor	Collaborator
Oslo Metropolitan University	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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, in last trimester, at 6, 12 and 24 months postpartum
Primary	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	at 12 and 24 months postpartum
Primary	Child welfare service reports	Total number of reports to the child welfare service due to violence since birth	24 months postpartum
Primary	Child welfare service measures	Total number of provided measures and care takeovers due to violence since birth	24 months postpartum
Primary	Injuries (change is being assessed)	Hospital admissions	at delivery, 6, 12 and 24 months postpartum
Secondary	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	at 6, 12 and 24 months postpartum
Secondary	Interaction between mother and child	Emotional Availability Scale. Items are scored on a scale ranging from 1-7, where higher scores indicate better outcomes	at 12 months postpartum
Secondary	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	at baseline, and at 6, 12 and 24 months postpartum
Secondary	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	at 6, 12 and 24 months postpartum
Secondary	Child Development	Bayley scale of infant development	at 24 months postpartum
Secondary	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	baseline, in last trimester, at 6, 12 and 24 months postpartum
Secondary	Health behaviour (change is being assessed)	Use of tobacco, alcohol, drugs	baseline, in last trimester, at 6, 12 and 24 months postpartum