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Clinical Trials/NCT03991416
NCT03991416CompletedNot Applicable

Understanding Your Baby: A Universal Parenting Support Program Aiming at Increasing Danish First Time Parents' Abilities for Understanding and Meeting Their Infants' Needs

University of Copenhagen2 sites in 1 country1,737 target enrollmentStarted: May 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,737
Locations
2
Primary Endpoint
Maternal Parenting Competence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Understanding Your Baby

Experimental

Understanding Your Baby plus postnatal care as usual

Intervention: Understanding Your Baby (Behavioral)

Care As Usual

Active Comparator

Postnatal care as usual

Intervention: Postnatal care as usual (Behavioral)

Outcomes

Primary Outcomes

Maternal Parenting Competence

Time Frame: T4 (infant age 11-11.5 months)

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

Secondary Outcomes

  • 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 Parenting Stress(T2 (infant age 4-4.5 months) and T4 (infant age 11-11.5 months))
  • 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 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))
  • Infant socio-emotional development(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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mette Væver

PhD, Associate Professor

University of Copenhagen

Study Sites (2)

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