What Are the Effects of Supporting Early Parenting by Increasing the Understanding of the Infant?

January 3, 2023 updated by: Hanne Kronborg, University of Aarhus

What Are the Effects of Supporting Early Parenting by Increasing the Understanding of the Infant? A Randomized Community Based Trial

Key research question This project addresses the following key research question: What are the short and long term effects on child and family outcomes of a universal intervention delivered by a Health Visitor addressing the newborn´s behavior in a shared observation with the parents (NBO)? The aim is to enhance the parent's sensitivity to their infants' unique capacities and thereby create an early parental understanding for the individual infant's strengths as well as its needs.

Hypothesis concerning main outcomes

Universal Health Visiting with facilitation of the early relationship building introduced by the NBO to an intervention group of new families will- when compared to a control group of new families who receive health visitor support as usual:

  • Improve sensitive responsive parenting to the infant's behavior, needs for feeding and comfort, and rise understanding of parental influence on the infants' self-regulatory capacities
  • Increase parental confidence and reduce experiences of stress and symptoms of depression among new mothers and fathers
  • Improve the infant's self-regulatory capacities regarding sleep, crying, feeding and engaging in social interactions, being more cooperative
  • Enhance the sensitive early parent/infant relationship
  • Improve exclusive breastfeeding duration and delay introduction to solid food

Method The project is formed as a community based randomized trial. The complexity in community based intervention research is the existence of two target groups, in this case: 1) the primary study population of new parents that receive the supportive intervention and 2) the secondary study population of Health Visitors that deliver the supportive intervention. The complication of catching the effects in a universal approach will be addressed through a variety of outcomes that capture both the aspect and the development of the infant, the mother and the father and the interactions.

Recruitment and randomization Four medium-sized municipalities will join in the trial. To avoid side-effects the districts of the Health Visitors in the participating municipalities will be regarded as clusters. A restricted randomization procedure is decided to achieve balance in the two study arms because of a relatively small number of clusters (n=17) with huge differences in birth rate. The criteria for the restricted randomization is a geographical balance with all participating municipalities represented by both intervention and comparison districts and a numerical balance with expected number of births attempted between the intervention and comparison group. An external data manager performed the entire procedure.

Study population The primary study population is formed by new families, mothers and fathers and their infant/s. Substantiated in that we are operating with a community based universal intervention with no side effects and we seek to measure the effect in a natural population we will have no exclusion criteria except parents or infants affiliated to special treatment elsewhere.

In the study population of new parents there will be subgroups: First time parents will represent around 40 %, around 6 % will have given premature birth, 2% twin birth, 10-14% of the mothers and 7-8% of the fathers will suffer from birth depression in the postnatal period, and 7-20% will have a cultural background other than Danish depending on geographical area.

A subgroup of 100 first-time mothers in each group of intervention and comparison are drawn consecutively among responders for video recording in the middle of the project period after specified characteristic criteria with regard to first-time-, depressed- and given premature birth.

Data and data-collection Data will be collected from two sources: (1) self-reported data from the new parents collected via questionnaire; (2) observational data from video recordings, Infant CARE-Index. Questionnaire data will be delivered and collected though an internet based system. Participating mothers and fathers will receive separate questionnaires at 1-2 weeks postpartum (baseline data), 3 months postpartum, 9 months follow-up, 18 months follow-up. Videos are recorded at 3 months post-partum (corrected age for premature infants) with 3 minutes of unstructured time together; (Infant CARE Index). All data will be linked via the Danish Personal Register (CPR) identifier. To minimize bias introduced by data collection, data will be collected in the same way and with the same timing in the intervention and comparison groups.

Data Analysis Intention to treat analysis will be used to detect the effect of the community based intervention where motivation and participation may vary in both the primary and secondary study population. Supplemental analysis will be performed to identify an intervention effect for subgroups and marginal groups of parents according to parity, preterm delivery, and depression symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2566

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Institute of Publich Health, Department of Nursing Science, University of Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The primary study population is formed by new families, mothers and fathers and their newborn/s. Substantiated in that we are operating with a community based universal intervention with no side effects and we seek to measure the effect in a natural population we will have no exclusion criteria

Exclusion Criteria:

  • except parents or infants affiliated to special treatment elsewhere.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NBO, Newborn behavioral observation
In the intervention group new parents will receive the NBO delivered in connection with the examination of the newborn in a shared observation with the parents in the homevisit of the health visitor 3 weeks post partum
Behavioral: NBO, Newborn behavioral observation
Experimental: Practice as usual
In the comparison group new parents will receive practice as usual due to the examination of their newborn in the homevisit of the health visitor 3 weeks post partum
Behavioral: Practice as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Karitane parenting confidence scale, KPCS. Change is being assessed.
Time Frame: measured at 2 weeks, 3 and 9 months post partum
Parents´sense of confidence
measured at 2 weeks, 3 and 9 months post partum
Infant Care Index
Time Frame: measured 4 months post partum
Parental sensitivity, responsiveness and early parent infant relationship
measured 4 months post partum
Ages & States questionnarie, ASQ-SE. Change is being assessed.
Time Frame: measured at 2 weeks, 3 and 9 months post partum
Infant's self-regulatory capacities, understanding of parental influence on the infants' self-regulatory capacities
measured at 2 weeks, 3 and 9 months post partum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Major Depression Inventory (MDI10)
Time Frame: measured at 2 weeks, 3 and 9 months post partum
Depression associated with parenting
measured at 2 weeks, 3 and 9 months post partum
Breast-feeding period in weeks
Time Frame: measured at 3 and 9 months
The duration of full breastfeeding following birth measured in weeks
measured at 3 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Hanne Kronborg, Section of Nursing, Department of Public Health, Aarhus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SUN-Aarhus-2017- 653

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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