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New Families- Innovation and Development of the Child Health Services in Oslo

New Families- Innovation and Development of the Child Health Services in Oslo

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04162626
Acronym
NF
Enrollment
428
Registered
2019-11-14
Start date
2018-10-08
Completion date
2021-10-01
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Prevention

Keywords

public health nurse, intervention, home visit

Brief summary

The New Families (NF) program will improve quality of existing services, secure personalised service and early intervention in Child Health Service (CHS) in Oslo. The study will measure the effects of a primary prevention family-centered healthcare intervention in Norwegian CHS.

Detailed description

The New Families (NF) program will improve quality of existing services, secure personalised service and early intervention in Child Health Service (CHS) in Oslo. The study will: 1) Measure the effects of a primary prevention family-centered healthcare intervention in Norwegian CHS, 2) Create case studies from CHS praxis advancing Public Health Nurse (PHN) training and education in Oslo and Norway, 3) Establish a model for how to include users in service development in CHS, 4) Enhance the knowledge base of the PHN practice in CHS Anticipated results: The project will bolster the knowledge base for education and professional practices within the service by strengthen the existing research within the field. The anticipated results of the project are that the intervention will increase maternal and parental self-efficacy, reduce the risk of postpartum depression among first-time mothers, reduce parental stress, increase social support, improve maternal attachment, improve generic health status, improve partner relationship and improve child development compared with usual care. The intervention research in this project can be a future model for service improvement in the CHS.

Interventions

OTHERSupportive home visits to new families

The new families are offered home visits by a public health nurse from 28 weeks in pregnancy until the child is two years old. The number of home visits depends on the families needs and wishes. They also get the usual follow up from the Child health center.

OTHERTreatment as usual

Follow up at the Child health center according to national regulations

Sponsors

Oslo Municipality
CollaboratorOTHER_GOV
University of Oslo
CollaboratorOTHER
Norwegian Institute of Public Health
CollaboratorOTHER_GOV
The Research Council of Norway
CollaboratorOTHER
VID Specialized University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* First time parents living in the chosen districts

Exclusion criteria

* All other parents

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life in women and men during pregnancy and postpartumPregnancy week 28, 3 months postpartum, 12 months postpartum.To explore first-time parents' QoL during pregnancy and first-time mothers QoL postpartum, and to evaluate the difference in QoL between mothers in the intervention and control districts. Instrument: WHOQOL-BREF, 26-item. Score 4-20, higher scores indicate higher QoL.
Depression in mothers in pregnancy28 weeks pregnancyEdinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.
Depression in fathers when partner is pregnant28 weeks pregnancyEdinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.
Depression in mothers three months postpartum3 months postpartumEdinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.
Depression in fathers three months postpartum3 months postpartumEdinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.
Sense of Coherence in mothers in pregnancy28 weeks pregnancySense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.
Sense of Coherence in fathers in pregnancy28 weeks pregnancySense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.
Sense of Coherence in mothers three months postpartum3 months postpartumSense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.
Sense of Coherence in fathers three months postpartum3 months postpartumSense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.
Self-Efficacy in mothers 6 weeks postpartum6 weeks postpartumPerceived Maternal Parenting Self-Efficacy (PMP S-E) 20 items. score 22-88. A higher score indicates a higher level of maternal self-efficacy
Self-Efficacy in fathers 6 weeks postpartum6 weeks postpartumPerceived Maternal Parenting Self-Efficacy (PMP S-E) 20 items. score 22-88. A higher score indicates a higher level of maternal self-efficacy
Self-Efficacy in mothers 3 months postpartum3 months postpartumPerceived Maternal Parenting Self-Efficacy (PMP S-E) 20 items. score 22-88. A higher score indicates a higher level of maternal self-efficacy
Self-Efficacy in fathers 3 months postpartum3 months postpartumPerceived Maternal Parenting Self-Efficacy (PMP S-E) 20 items. score 22-88. A higher score indicates a higher level of maternal self-efficacy
Parental Stress in fathers 3 months postpartum3 months postpartumParental Stress Scale (PSS) is formatted in the form of an 18-item self-report scale. Items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. A higher score indicates a higher level of parental stress.
Parental Stress in mothers 3 months postpartum3 months postpartumParental Stress Scale (PSS) is formatted in the form of an 18-item self-report scale. Items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. A higher score indicates a higher level of parental stress.

Secondary

MeasureTime frameDescription
What are the barriers and facilitators to implementation of the PHN intervention?The interviews will take place about 12 months postpartumThis research question will be explored by addressing the process of implementation. Data will be collected through a short survey and semi-structured interviews with PHNs and users (first-time mothers/fathers). An interview guide will be developed

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026