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Clinical Trials/NCT04162626
NCT04162626CompletedNot Applicable

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

VID Specialized University2 sites in 1 country428 target enrollmentStarted: October 8, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
428
Locations
2
Primary Endpoint
Self-Efficacy in fathers 6 weeks postpartum

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • First time parents living in the chosen districts

Exclusion Criteria

  • All other parents

Outcomes

Primary Outcomes

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

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 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?(The interviews will take place about 12 months postpartum)

Investigators

Sponsor
VID Specialized University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kari Glavin

Professor

VID Specialized University

Study Sites (2)

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