- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03991416
Understanding Your Baby: A Parallel Group Study of a Universal Parenting Support Program
Understanding Your Baby: A Universal Parenting Support Program Aiming at Increasing Danish First Time Parents' Abilities for Understanding and Meeting Their Infants' Needs
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 1353
- Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Understanding Your Baby
Understanding Your Baby plus postnatal care as usual
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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:
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Active Comparator: Care As Usual
Postnatal care as usual
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Parenting Competence
Time Frame: T4 (infant age 11-11.5 months)
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Maternal Parenting Competence is assessed via self-report using the Parenting Sense of Competence Scale (PSOC; Gibaud-Wallston, 1977).
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T4 (infant age 11-11.5 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Maternal and paternal parenting competence is assessed via self-report using the Parenting Sense of Competence Scale (PSOC; Gibaud-Wallston, 1977).
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T1 (infant age 2-2.5 months), T2 (infant age 4-4.5 months), and T3 (infant age 7-7.5 months)
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Maternal and Paternal Parenting Stress
Time Frame: T2 (infant age 4-4.5 months) and T4 (infant age 11-11.5 months)
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Maternal and paternal parenting stress is assessed via self-report using the Parenting Stress Index™, Third Edition Short Form (PSI-3-SF; Abidin, 1995).
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T2 (infant age 4-4.5 months) and T4 (infant age 11-11.5 months)
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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)
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Maternal and paternal parental mentalizing is assessed via self-report using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten, Mayes, Nijssens, & Fonagy, 2017).
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T2 (infant age 4-4.5 months), T3 (infant age 7-7.5 months), and T4 (infant age 11-11.5 months)
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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)
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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).
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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)
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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)
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Maternal, paternal and child screen use is measured using a questionnaire developed specifically for this research project.
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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)
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Infant socio-emotional development
Time Frame: T4 (infant age 11-11.5 months)
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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).
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T4 (infant age 11-11.5 months)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mette S. Væver, Department of Psychology, University of Copenhagen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UCPH 2019-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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