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

NCT04162626 | Completed

• 1 other identifier: 2018/1378
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Prevention

Keywords

public health nurse; intervention; home visit

Outcome Measures

Primary Outcomes (15)

• 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

• 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.

  Pregnancy week 28, 3 months postpartum, 12 months postpartum.

Secondary Outcomes (1)

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

  The interviews will take place about 12 months postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

Follow up as usual at the Child health center

Other: Treatment as usual

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.

Intervention

Treatment as usual OTHER

Follow up at the Child health center according to national regulations

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First time parents living in the chosen districts

You may not qualify if:

• All other parents

Sponsors & Collaborators

• VID Specialized University: lead
• Oslo Municipality: collaborator
• University of Oslo: collaborator
• Norwegian Institute of Public Health: collaborator
• The Research Council of Norway: collaborator

Study Sites (1)

VID Specialized University

Oslo, NO-0319, Norway

Location

Related Publications (1)

• Brekke 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.

  PMID: 38066502 DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

• Kari Glavin, PhD

  VID Specialized University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: October 8, 2018
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)