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Completed

NCT Number: NCT03991416

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

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.

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Key information

Conditions

First-time Mothers and Their Partners

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, 1353, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Understanding Your Baby

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.

Other names: Forstaa din baby

Postnatal care as usual

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.

Primary outcomes

  1. 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

  1. Maternal and Paternal Parenting Competence

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

  2. Maternal and Paternal Parenting Stress

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

    Maternal and paternal parenting stress is assessed via self-report using the Parenting Stress Index™, Third Edition Short Form (PSI-3-SF; Abidin, 1995).

  3. Maternal and Paternal Parental Mentalizing

    Time frame: 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 parental mentalizing is assessed via self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, & Fonagy, 2017).

  4. Maternal and Paternal Mind-Mindedness

    Time frame: 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 and paternal mind-mindedness are assessed using a written response to the first question from the "Describe you child" interview (Meins et al., 1998). Mind-mindedness is coded according to the criteria specified in the mind-mindedness coding manual (Meins & Fernyhough, 2015).

  5. Maternal, paternal and child screen use

    Time frame: 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 is measured using a questionnaire developed specifically for this research project.

  6. Infant socio-emotional development

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

    Infant socio-emotional development is assessed via parental report using the Ages & Stages Questionnaires®: Social-Emotional, Second Edition (ASQ:SE-2; Squires, Bricker, & Twombly, 2015).

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Nordea-fonden

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Jun 19, 2019
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.