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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Prevention

Intervention / Treatment
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* Other: Supportive home visits to new families
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time parents living in the chosen districts Exclusion Criteria: All other parents

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| Other: Control<br>Follow up as usual at the Child health center | Other: Treatment as usual<br>* Follow up at the Child health center according to national regulations<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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public health nurse, intervention, home visit