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

Primary Prevention Clinical Trial

— NF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162626
• Other study ID #: 2018/1378
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: VID Specialized University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: October 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First time parents living in the chosen districts

Exclusion Criteria:

• All other parents

Related Conditions & MeSH terms

• Primary Prevention

Intervention

Other:
• Supportive 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.
• Treatment as usual
Follow up at the Child health center according to national regulations

Locations

Country	Name	City	State
Norway	VID Specialized University	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
VID Specialized University	Municipality of Oslo, Norway, Norwegian Institute of Public Health, The Research Council of Norway, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression in mothers in pregnancy	Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.	28 weeks pregnancy
Primary	Depression in fathers when partner is pregnant	Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.	28 weeks pregnancy
Primary	Depression in mothers three months postpartum	Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.	3 months postpartum
Primary	Depression in fathers three months postpartum	Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.	3 months postpartum
Primary	Sense of Coherence in mothers in pregnancy	Sense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.	28 weeks pregnancy
Primary	Sense of Coherence in fathers in pregnancy	Sense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.	28 weeks pregnancy
Primary	Sense of Coherence in mothers three months postpartum	Sense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.	3 months postpartum
Primary	Sense of Coherence in fathers three months postpartum	Sense of Coherence Scale (SOC 13). 26 items. Score 13-90. Higher score is positive, score under 66 is low.	3 months postpartum
Primary	Self-Efficacy in mothers 6 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	6 weeks postpartum
Primary	Self-Efficacy in fathers 6 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	6 weeks postpartum
Primary	Self-Efficacy in mothers 3 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	3 months postpartum
Primary	Self-Efficacy in fathers 3 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	3 months postpartum
Primary	Parental Stress in fathers 3 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.	3 months postpartum
Primary	Parental Stress in mothers 3 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.	3 months postpartum
Secondary	What are the barriers and facilitators to implementation of the PHN intervention?	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	The interviews will take place about 12 months postpartum