Understanding Your Baby: A Parallel Group Study of a Universal Parenting Support Program

NCT ID: NCT03991416

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1737 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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First-time Mothers and Their Partners

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Understanding Your Baby

Understanding Your Baby plus postnatal care as usual

Group Type EXPERIMENTAL

Understanding Your Baby

Intervention Type BEHAVIORAL

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.

Care As Usual

Postnatal care as usual

Group Type ACTIVE_COMPARATOR

Postnatal care as usual

Intervention Type BEHAVIORAL

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.

Interventions

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Understanding Your Baby

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.

Intervention Type BEHAVIORAL

Postnatal care as usual

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Forstaa din baby

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Under the age of 18 when the child is born
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordea-fonden

UNKNOWN

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Mette Væver

PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette S. Væver

Role: PRINCIPAL_INVESTIGATOR

Department of psychology, University of Copenhagen

Locations

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

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36138482 (View on PubMed)

Other Identifiers

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UCPH 2019-02

Identifier Type: -

Identifier Source: org_study_id

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