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

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.

Study Overview

• Status: Completed
• Conditions: Primary Prevention
• Intervention / Treatment: Other: Supportive home visits to new families; Other: Treatment as usual

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.

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, NO-0319
    • VID Specialized University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First time parents living in the chosen districts

Exclusion Criteria:

• All other parents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Supportive home visits by public health nurses to new parents from 28 weeks in pregnancy until the child is two years.	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.
Other: Control; Follow up as usual at the Child health center	Other: Treatment as usual; Follow up at the Child health center according to national regulations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VID Specialized University
• Collaborators: University of Oslo; Norwegian Institute of Public Health; The Research Council of Norway; Municipality of Oslo, Norway
• Investigators: Principal Investigator: Kari Glavin, PhD, VID Specialized University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: intervention; home visit; public health nurse
• Other Study ID Numbers: 2018/1378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There will be four doctoral students (PhD) in the project

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No