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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05895604
Other study ID # NFP-202862
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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 childĀ“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

Study Design


Related Conditions & MeSH terms


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
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