Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
700 participants
INTERVENTIONAL
2023-06-01
2042-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment-NFP
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).
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
Control
Control group members have access to the standard of care and whatever other programs and services are available in the community.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
16 Years
FEMALE
Yes
Sponsors
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University of Oslo
OTHER
Norwegian Institute of Public Health
OTHER_GOV
The Norwegian Directorate for Children, Youth and Family Affairs
OTHER
Norwegian Center for Violence and Traumatic Stress Studies
OTHER
Regional centre for children and youth mental health and welfare
OTHER
Oslo Metropolitan University
OTHER
Responsible Party
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Principal Investigators
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Anne Grete Tøge, phd
Role: PRINCIPAL_INVESTIGATOR
Oslo Metropolitan University
Eirin Pedersen, phd
Role: PRINCIPAL_INVESTIGATOR
Oslo Metropolitan University
Locations
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Region Vestland
Bergen, Bergen, Norway
Region Agder
Kristiansand, Kristiansand, Norway
Region Rogaland
Sandnes, Sandnes, Norway
Region Trøndelag
Trondheim, Trondheim, Norway
Region Oslo
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NFP-202862
Identifier Type: -
Identifier Source: org_study_id
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