---
title: New Families- Innovation and Development of the Child Health Services in Oslo
nct_id: NCT04162626
overall_status: COMPLETED
phase: NA
sponsor: VID Specialized University
study_type: INTERVENTIONAL
primary_condition: Primary Prevention
countries: Norway
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04162626.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04162626"
ct_last_update_post_date: 2025-01-13
last_seen_at: "2026-05-12T06:45:37.784Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# New Families- Innovation and Development of the Child Health Services in Oslo

**NCT ID:** [NCT04162626](https://clinicaltrials.gov/study/NCT04162626)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 428
- **Lead Sponsor:** VID Specialized University
- **Collaborators:** Oslo Municipality, University of Oslo, Norwegian Institute of Public Health, The Research Council of Norway
- **Conditions:** Primary Prevention
- **Start Date:** 2018-10-08
- **Completion Date:** 2021-10-01
- **CT.gov Last Update:** 2025-01-13

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* First time parents living in the chosen districts

Exclusion Criteria:

* All other parents
```

## Arms

- **Intervention** (EXPERIMENTAL) — Supportive home visits by public health nurses to new parents from 28 weeks in pregnancy until the child is two years.
- **Control** (OTHER) — Follow up as usual at the Child health center

## Interventions

- **Supportive home visits to new families** (OTHER) — 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** (OTHER) — Follow up at the Child health center according to national regulations

## Primary Outcomes

- **Depression in mothers in pregnancy** _(time frame: 28 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 pregnant** _(time frame: 28 weeks pregnancy)_ — Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.
- **Depression in mothers three months postpartum** _(time frame: 3 months postpartum)_ — Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.
- **Depression in fathers three months postpartum** _(time frame: 3 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 pregnancy** _(time frame: 28 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 pregnancy** _(time frame: 28 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 postpartum** _(time frame: 3 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 postpartum** _(time frame: 3 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 postpartum** _(time frame: 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
- **Self-Efficacy in fathers 6 weeks postpartum** _(time frame: 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
- **Self-Efficacy in mothers 3 months postpartum** _(time frame: 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
- **Self-Efficacy in fathers 3 months postpartum** _(time frame: 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
- **Parental Stress in fathers 3 months postpartum** _(time frame: 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.
- **Parental Stress in mothers 3 months postpartum** _(time frame: 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.
- **Quality of Life in women and men during pregnancy and postpartum** _(time frame: Pregnancy 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 Outcomes

- **What are the barriers and facilitators to implementation of the PHN intervention?** _(time frame: The interviews will take place about 12 months postpartum)_

## Locations (1)

- VID Specialized University, Oslo, Norway

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.vid specialized university|oslo||norway` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04162626.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04162626*  
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