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

Not Applicable
Completed
Conditions
Primary Prevention
Interventions
Other: Supportive home visits to new families
Other: Treatment as usual
Registration Number
NCT04162626
Lead Sponsor
VID Specialized University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
428
Inclusion Criteria
  • First time parents living in the chosen districts
Exclusion Criteria
  • All other parents

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionSupportive home visits to new familiesSupportive home visits by public health nurses to new parents from 28 weeks in pregnancy until the child is two years.
ControlTreatment as usualFollow up as usual at the Child health center
Primary Outcome Measures
NameTimeMethod
Self-Efficacy in fathers 6 weeks postpartum6 weeks postpartum

Perceived 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 postpartum

Perceived Maternal Parenting Self-Efficacy (PMP S-E) 20 items. score 22-88. A higher score indicates a higher level of maternal self-efficacy

Depression in mothers in pregnancy28 weeks pregnancy

Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.

Depression in fathers when partner is pregnant28 weeks pregnancy

Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.

Depression in mothers three months postpartum3 months postpartum

Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.

Depression in fathers three months postpartum3 months postpartum

Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.

Sense of Coherence in mothers in pregnancy28 weeks pregnancy

Sense 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 pregnancy

Sense 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 postpartum

Sense 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 postpartum

Sense 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 postpartum

Perceived 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 postpartum

Perceived 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 postpartum

Parental 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 postpartum

Parental 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.

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.

Secondary Outcome Measures
NameTimeMethod
What are the barriers and facilitators to implementation of the PHN intervention?The interviews will take place about 12 months postpartum

This 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

Trial Locations

Locations (1)

VID Specialized University

🇳🇴

Oslo, Norway

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