Clinical trial NCT04162626: New Families- Innovation and Development of the Child Health Services in Oslo
Official title: New Families- Innovation and Development of the Child Health Services in Oslo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Keywords: public health nurse
intervention
home visit
Lead sponsor: VID Specialized University
Sponsor class: OTHER
Collaborators: name: Oslo Municipality
name: University of Oslo
name: Norwegian Institute of Public Health
name: The Research Council of Norway
First posted: 2019-11-14
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* First time parents living in the chosen districts

Exclusion Criteria:

* All other parents

Primary outcomes:
measure: Depression in mothers in pregnancy
timeFrame: 28 weeks pregnancy
measure: Depression in fathers when partner is pregnant
timeFrame: 28 weeks pregnancy
measure: Depression in mothers three months postpartum
timeFrame: 3 months postpartum
measure: Depression in fathers three months postpartum
timeFrame: 3 months postpartum
measure: Sense of Coherence in mothers in pregnancy
timeFrame: 28 weeks pregnancy
measure: Sense of Coherence in fathers in pregnancy
timeFrame: 28 weeks pregnancy
measure: Sense of Coherence in mothers three months postpartum
timeFrame: 3 months postpartum
measure: Sense of Coherence in fathers three months postpartum
timeFrame: 3 months postpartum
measure: Self-Efficacy in mothers 6 weeks postpartum
timeFrame: 6 weeks postpartum
measure: Self-Efficacy in fathers 6 weeks postpartum
timeFrame: 6 weeks postpartum
measure: Self-Efficacy in mothers 3 months postpartum
timeFrame: 3 months postpartum
measure: Self-Efficacy in fathers 3 months postpartum
timeFrame: 3 months postpartum
measure: Parental Stress in fathers 3 months postpartum
timeFrame: 3 months postpartum
measure: Parental Stress in mothers 3 months postpartum
timeFrame: 3 months postpartum
measure: Quality of Life in women and men during pregnancy and postpartum
timeFrame: Pregnancy week 28, 3 months postpartum, 12 months postpartum.
Secondary outcomes:
measure: What are the barriers and facilitators to implementation of the PHN intervention?
timeFrame: The interviews will take place about 12 months postpartum
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: VID Specialized University
Study officials:
affiliation: VID Specialized University
name: Kari Glavin, PhD
role: PRINCIPAL_INVESTIGATOR
References: