What Are the Effects of Supporting Early Parenting by Increasing the Understanding of the Infant?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03070652|
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : March 13, 2017
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. Because of differences in size and social status of the inhabitants in the districts alias the clusters, the clusters will be stratified before they are randomized to intervention or comparison group. The randomization procedure will be computer based and conducted by an independent person not involved in the study.
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 random sample of 100 mothers who have received the intervention will be drawn for video recording in the middle of the project period after specified characteristic criteria with regard to first-time-, depressed- and given premature birth. Afterwards a matched group of 100 mothers will be selected in the comparison group.
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.
|Condition or disease||Intervention/treatment||Phase|
|Parent-Child Relations||Behavioral: NBO, Newborn behavioral observation Behavioral: Practice as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2730 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||What Are the Effects of Supporting Early Parenting by Increasing the Understanding of the Infant? A Randomized Community Based Trial|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||January 31, 2018|
|Estimated Study Completion Date :||July 31, 2019|
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
- 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
- Infant Care Index [ Time Frame: measured 4 months post partum ]Parental sensitivity, responsiveness and early parent infant relationship
- 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
- The Major Depression Inventory (MDI10) [ Time Frame: measured at 2 weeks, 3 and 9 months post partum ]Depression associated with parenting
- Breast-feeding period in weeks [ Time Frame: measured at 3 and 9 months ]The duration of full breastfeeding following birth measured in weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070652
|Institute of Publich Health, Department of Nursing Science, University of Aarhus||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Hanne Kronborg, Ph.D. +45 30233626 firstname.lastname@example.org|
|Contact: Ingeborg H. Kristensen, Ph.D. +45 29335551 email@example.com|
|Principal Investigator: Hanne Kronborg, Ph.D.|
|Principal Investigator:||Hanne Kronborg||Section of Nursing, Department of Public Health, Aarhus University|