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

Not Applicable

Active, not recruiting

• Conditions: First-time Mothers and Their Partners
• Interventions: Behavioral: Understanding Your Baby; Behavioral: Postnatal care as usual

• Registration Number: NCT03991416
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-28
• Study Start: 2019-05-15
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Primary Completion: 2022-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1737

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Understanding Your Baby	Understanding Your Baby	Understanding Your Baby plus postnatal care as usual
Care As Usual	Postnatal care as usual	Postnatal care as usual

Primary Outcome Measures

Name	Time	Method
Maternal Parenting Competence	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 Outcome Measures

Name	Time	Method
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 parental mentalizing is assessed via self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, \& Fonagy, 2017).
Maternal and Paternal Parenting Stress	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).
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 parenting competence is assessed via self-report using the Parenting Sense of Competence Scale (PSOC; Gibaud-Wallston, 1977).
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)	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).
Infant socio-emotional development	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).
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)	Maternal, paternal and child screen use is measured using a questionnaire developed specifically for this research project.

Trial Locations

Locations (1)

Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen; 🇩🇰 Copenhagen, Denmark