NCT03991416

Brief Summary

In Understanding Your Baby first-time parents receive research-based knowledge on how to interpret their infants' socioemotional needs based on their behavior, and how to meet their infants' socioemotional needs in accordance with their developmental stage. This information is delivered to parents at routine home visits by public health nurses, who are trained in the research base behind the program, and using cue cards and short video clips, which concretely exemplify how infants signal their socioemotional needs and inspire to positive activities between parents and their infants. The aim of Understanding Your Baby is to support infant socioemotional development by increasing parents' abilities at perceiving, understanding, and responding to their infant's socioemotional signals. Evaluation is based on a parallel group study, with half of the participants receiving care as usual and half of the participants receiving care as usual and Understanding Your Baby. The primary outcome is parental sense of competence and secondary outcomes are parental stress and child socioemotional development.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,737

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

February 28, 2019

Last Update Submit

November 15, 2023

Conditions

Keywords

UniversalPreventionParental competenceSocioemotionalPublic health nurses

Outcome Measures

Primary Outcomes (1)

  • Maternal Parenting Competence

    Maternal Parenting Competence is assessed via self-report using the Parenting Sense of Competence Scale (PSOC; Gibaud-Wallston, 1977).

    T4 (infant age 11-11.5 months)

Secondary Outcomes (6)

  • Maternal and Paternal Parenting Competence

    T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), and T3 (infant age 7-7.5 months)

  • Maternal and Paternal Parenting Stress

    T2 (infant age 4-4.5 months) and T4 (infant age 11-11.5 months)

  • Maternal and Paternal Parental Mentalizing

    T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)

  • Maternal and Paternal Mind-Mindedness

    T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)

  • Maternal, paternal and child screen use

    T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)

  • +1 more secondary outcomes

Study Arms (2)

Understanding Your Baby

EXPERIMENTAL

Understanding Your Baby plus postnatal care as usual

Behavioral: Understanding Your Baby

Care As Usual

ACTIVE COMPARATOR

Postnatal care as usual

Behavioral: Postnatal care as usual

Interventions

Research-based knowledge on the understanding and meeting of the baby's socioemotional needs is delivered to the parents systematically by public health visitors based on a manual, cue cards, and video clips at four time points from 1 to 10 months postpartum.

Also known as: Forstaa din baby
Understanding Your Baby

In accordance with Danish national guidelines, health visitors visit families during the infants first year of life, where they weigh and measure the infant. Further, they offer individual guidance and support regarding for instance feeding, sleeping, how to stimulate the infant, and the developmental stages that the infant goes through.

Care As Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-time mother or father/partner
  • Singleton pregnancy
  • Mother living together with the baby
  • Mother living in the Danish municipalities of Køge, Hvidovre, Høje-Taastrup, Frederiksberg, Lolland, Holbæk, Næstved, Middelfart, Nyborg or Aalborg.
  • Understands Danish or English

You may not qualify if:

  • Under the age of 18 when the child is born

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen

Copenhagen, 1353, Denmark

Location

Related Publications (1)

  • Vaever MS, Krogh MT, Stuart AC, Madsen EB, Haase TW, Egmose I. Understanding Your Baby: protocol for a controlled parallel group study of a universal home-based educational program for first time parents. BMC Psychol. 2022 Sep 22;10(1):223. doi: 10.1186/s40359-022-00924-3.

MeSH Terms

Interventions

Postnatal Care

Intervention Hierarchy (Ancestors)

Perinatal CarePatient CareTherapeuticsMaternal Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mette S. Væver

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

February 28, 2019

First Posted

June 19, 2019

Study Start

May 15, 2019

Primary Completion

September 30, 2022

Study Completion

December 31, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations