Primary PreventionNFNCT04162626
New Families- Innovation and Development of the Child Health Services in Oslo
A study testing Supportive home visits to new families and Treatment as usual in people with Primary Prevention, run by VID Specialized University at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention
- What is being tested?
- Supportive home visits to new families and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteNorway
- Study dates
- 8 Oct 2018to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First time parents living in the chosen districts
Who cannot join
- All other parents
Trial locations and contacts
1 site in 1 country.
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 measure the effects of a primary prevention family-centered healthcare intervention in Norwegian CHS.
Read the 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.
- Conditions
- Primary Prevention
- Being tested
- Supportive home visits to new families, Treatment as usual
- Keywords
- public health nurse, intervention, home visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive home visits to new familiesOther
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 usualOther
Follow up at the Child health center according to national regulations
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Supportive home visits by public health nurses to new parents from 28 weeks in pregnancy until the child is two years. Receives: Other: Supportive home visits to new families |
| Control | Other | Follow up as usual at the Child health center Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression in mothers in pregnancy
Edinburgh postnatal depression scale (EPDS). 10 items. Score 0-30. Score 12 or above indicate postpartum depression.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 3 months postpartum
Quality of Life in women and men during pregnancy and 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.
Measured: Pregnancy week 28, 3 months postpartum, 12 months postpartum.
Secondary outcomes (1)
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
Measured: The interviews will take place about 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start8 Oct 2018
- Primary completion1 Jun 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- VID Specialized University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Municipality, University of Oslo, Norwegian Institute of Public Health, The Research Council of Norway
- Responsible party
- Principal investigator, Kari Glavin, VID Specialized University
- Investigators
- Kari Glavin, PhD, Principal investigator, VID Specialized University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162626
- Sponsor's protocol ID
- 2018/1378
- Acronym
- NF
- Status last verified
- Jan 2025
- First submitted
- 11 Nov 2019
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be four doctoral students (PhD) in the project
Publications
Saether KM, Hagen MC, Holmberg Fagerlund B, Glavin K, Brekke M, Solberg B, Oygarden AU, Joranson N. The Impact of a Home Visiting Program on First-Time Parents' Parental Self-Efficacy in Norway and Associations between Parental Self-Efficacy, Depressive Symptoms and Perception of Sleep. Public Health Nurs. 2026 May-Jun;43(3):653-666. doi: 10.1111/phn.70098. Epub 2026 Feb 28.
PubMed 41762203Brekke M, Smastuen MC, Glavin K, Amro A, Solberg B, Oygarden AU, Saether KM, Haugland T. The impact of New Families home visiting program on first-time mothers' quality of life and its association with social support: a non-randomized controlled study. BMC Public Health. 2023 Dec 8;23(1):2457. doi: 10.1186/s12889-023-17285-0.
PubMed 38066502
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Families- Innovation and Development of the Child Health Services in Oslo
- ClinicalTrials.gov ID
- NCT04162626
- Acronym / sponsor ID
- NF / 2018/1378
- Conditions
- Primary Prevention
- Keywords
- public health nurse, intervention, home visit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- VID Specialized UniversityUniversity, hospital or other
- Collaborators
- Oslo Municipality, University of Oslo, Norwegian Institute of Public Health, The Research Council of Norway
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Supportive home visits to new familiesSupportive home visits by public health nurses to new parents from 28 weeks in pregnancy until the child is two years. |
| Control | Other | Other: Treatment as usualFollow up as usual at the Child health center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First time parents living in the chosen districts
Key exclusion criteria (1 listed)
- All other parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive home visits to new familiesThe 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 | Intervention |
| Treatment as usualFollow up at the Child health center according to national regulations | Other | Control |
Primary outcome
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.
1 secondary outcome
What are the barriers and facilitators to implementation of the PHN intervention?
Time frame: The interviews will take place about 12 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Derived from this study: PubMed 41762203Saether KM, Hagen MC, Holmberg Fagerlund B, Glavin K, Brekke M, Solberg B, Oygarden AU, Joranson N. The Impact of a Home Visiting Program on First-Time Parents' Parental Self-Efficacy in Norway and Associations between Parental Self-Efficacy, Depressive Symptoms and Perception of Sleep. Public Health Nurs. 2026 May-Jun;43(3):653-666. doi: 10.1111/phn.70098. Epub 2026 Feb 28.
- Derived from this study: PubMed 38066502Brekke M, Smastuen MC, Glavin K, Amro A, Solberg B, Oygarden AU, Saether KM, Haugland T. The impact of New Families home visiting program on first-time mothers' quality of life and its association with social support: a non-randomized controlled study. BMC Public Health. 2023 Dec 8;23(1):2457. doi: 10.1186/s12889-023-17285-0.
- Individual participant dataSharing planned: No. There will be four doctoral students (PhD) in the project
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Glavin, PhD principal investigator
VID Specialized University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive home visits to new families and Treatment as usual in people with Primary Prevention, run by VID Specialized University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression in mothers in pregnancy (time frame: 28 weeks pregnancy). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162626, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.