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Completed

NCT Number: NCT04162626

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

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.

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Key information

Conditions

Primary Prevention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VID Specialized University

Oslo, NO-0319, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First time parents living in the chosen districts

Exclusion criteria

  • All other parents

Treatment and study plan

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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

  1. What are the barriers and facilitators to implementation of the PHN intervention?

    Time frame: The interviews will take place about 12 months postpartum

    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

Sponsors and collaborators

Lead sponsor

VID Specialized University

Other

Collaborators

  • Norwegian Institute of Public Health
  • Oslo Municipality
  • The Research Council of Norway
  • University of Oslo

Registry information

Acronym: NF

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 14, 2019
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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