Clinical trial NCT03991416: Understanding Your Baby: A Parallel Group Study of a Universal Parenting Support Program
Official title: Understanding Your Baby: A Universal Parenting Support Program Aiming at Increasing Danish First Time Parents' Abilities for Understanding and Meeting Their Infants' Needs
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: First-time Mothers and Their Partners
Keywords: Universal
Prevention
Parental competence
Socioemotional
Public health nurses
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Nordea-fonden
First posted: 2019-06-19
Enrollment: 1737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maternal Parenting Competence
timeFrame: T4 (infant age 11-11.5 months)
Secondary outcomes:
measure: Maternal and Paternal Parenting Competence
timeFrame: T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), and T3 (infant age 7-7.5 months)
measure: Maternal and Paternal Parenting Stress
timeFrame: T2 (infant age 4-4.5 months) and T4 (infant age 11-11.5 months)
measure: Maternal and Paternal Parental Mentalizing
timeFrame: T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)
measure: Maternal and Paternal Mind-Mindedness
timeFrame: 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)
measure: Maternal, paternal and child screen use
timeFrame: 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)
measure: Infant socio-emotional development
timeFrame: T4 (infant age 11-11.5 months)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
Study officials:
affiliation: Department of psychology, University of Copenhagen
name: Mette S. Væver
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.