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

First-time Mothers and Their Partners Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03991416
• Other study ID #: UCPH 2019-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1737
• Est. completion date: December 31, 2025
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• First-time Mothers and Their Partners

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Nordea-fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal and Paternal Parenting Competence	Maternal and paternal parenting competence is assessed via self-report using the Parenting Sense of Competence Scale (PSOC; Gibaud-Wallston, 1977).	T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), and T3 (infant age 7-7.5 months)
Secondary	Maternal and Paternal Parenting Stress	Maternal and paternal parenting stress is assessed via self-report using the Parenting Stress Index™, Third Edition Short Form (PSI-3-SF; Abidin, 1995).	T2 (infant age 4-4.5 months) and T4 (infant age 11-11.5 months)
Secondary	Maternal and Paternal Parental Mentalizing	Maternal and paternal parental mentalizing is assessed via self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, & Fonagy, 2017).	T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)
Secondary	Maternal and Paternal Mind-Mindedness	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).	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)
Secondary	Maternal, paternal and child screen use	Maternal, paternal and child screen use is measured using a questionnaire developed specifically for this research project.	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)
Secondary	Infant socio-emotional development	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).	T4 (infant age 11-11.5 months)