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

Sponsor

University of Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03991416

Collaborator

Nordea-fonden (Other)

1,320

Enrollment

Location

Arms

37.5

Anticipated Duration (Months)

35.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
First-time Mothers and Their Partners	Behavioral: Understanding Your Baby Behavioral: Postnatal care as usual	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1320 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

May 15, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Understanding Your Baby Understanding Your Baby plus postnatal care as usual	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. Other Names: Forstaa din baby
Active Comparator: Care As Usual Postnatal care as usual	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Understanding Your Baby

Understanding Your Baby plus postnatal care as usual

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.

Other Names:

Forstaa din baby

Active Comparator: Care As Usual

Postnatal care as usual

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

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 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 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 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).
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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen	Copenhagen		Denmark	1353

Sponsors and Collaborators

University of Copenhagen
Nordea-fonden

Investigators

Principal Investigator: Mette S. Væver, Department of psychology, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mette Væver, PhD, Associate Professor, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT03991416

Other Study ID Numbers:

UCPH 2019-02

First Posted:

Jun 19, 2019

Last Update Posted:

Feb 8, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mette Væver, PhD, Associate Professor, University of Copenhagen

Study Results

No Results Posted as of Feb 8, 2021