The Effect of the Newborn Behavioral Observations System on Maternal Sensitivity
Primary Purpose
Mother-Infant Interaction
Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
The Newborn behavioral observations system
Sponsored by
About this trial
This is an interventional prevention trial for Mother-Infant Interaction focused on measuring perinatal depression, maternal sensitivity, Infant emotion regulation
Eligibility Criteria
Inclusion Criteria:
- Pregnant women and their partners
- Age of 18 or more.
- Understanding Icelandic.
- Having score of EPDS scale of more than 9 or history of depression and/or anxiety
Exclusion Criteria:
- Not speaking or understanding Icelandic.
- Having given birth within 35 weeks of pregnancy.
- Having a sick baby
Sites / Locations
- Stefanía Birna Arnardóttir
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
NBO intervention for at-risk mothers
Treatment as usual
Arm Description
NBO intervention for at- risk mothers. 3 NBO sessions added to the routine follow-up delivered once per week during the first month postpartum. The intervention is delivered by a nurse certified in the NBO system.
Participants receive 3 routine follow-up by the local health visitor/midwife during the first month
Outcomes
Primary Outcome Measures
Maternal sensitivity
Maternal sensitivity is measured in the dyad of mother-infant communication; as appropriate responsiveness and ability to handle conflicts in the relationship. Scores for each subscale range from 1-7, higher scores indicating more sensitivity. Direct score range from 7-29, higher scores indicate more sensitivity. Direct score leads to Clinical-Screener score which is reated on a 100 point dimentional scale, divided into four zones; Emotional-Availability (81-100), Complicated E-A (61-80), Unavailable/Detached E-A (41-60) and Problematic/disturbed E-A (1-40).
The EA Scale is validated in various settings and cultures and will serve as the main outcome measure in the RCT.
Childs responsiveness
Childs responsiveness is measured in the dyad of mother-infant communication; as willingness to respond to bids of the adult without over-compliance. Scores for each subscale range from 1-7, higher scores indicating more responsivenss. Direct score range from 7-29, higher scores indicate more responsiveness. Direct score leads to Clinical-Screener score which is rated on a 100 point dimentional scale, divided into four zones; Emotional-Availability (81-100), Complicated E-A (61-80), Unavailable/Detached E-A (41-60) and Problematic/disturbed E-A (1-40)
Secondary Outcome Measures
Full Information
NCT ID
NCT04739332
First Posted
December 17, 2020
Last Updated
February 1, 2021
Sponsor
Center for Parents and Infants, Iceland
Collaborators
The Icelandic Nurses' Association, Health care of the capital area, Iceland, Research and Analysis, v/University of Reykjavik, Regionsenter for barn og unges psykiske helse, Norway
1. Study Identification
Unique Protocol Identification Number
NCT04739332
Brief Title
The Effect of the Newborn Behavioral Observations System on Maternal Sensitivity
Official Title
Assessing the Effect of the Newborn Behavioral Observations System on Maternal Sensitivity Four Months Post-partum
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
October 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Parents and Infants, Iceland
Collaborators
The Icelandic Nurses' Association, Health care of the capital area, Iceland, Research and Analysis, v/University of Reykjavik, Regionsenter for barn og unges psykiske helse, Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study evaluates if the Newborn Behavioral Observation system, a relationship building tool, delivered to at risk mothers will have, on one site, an effect on maternal sensitivity and the other site on Childs responsiveness, measured by the Emotional Availability (EA) Scales at 4 months post partum.
Detailed Description
The aim of this study is to evaluate the effect of the Newborn Behavioral Observation (NBO) on one site, on maternal sensitivity and on other site on Childs responsiveness, assessed by EAS at 4 months post partum. The NBO intervention serves to sensitize parents to the infant's capacities and individuality and to enhance the parent-infant relationship by strengthening parents 'confidence and practical skills in caring for their infants.
The study will use a RCT design. The NBO intervention group will be compared with a control group who will receive usual post partum care offered by primary health care in Reykjavik, Iceland. Inclusion criteria are pregnant women with an EPDS sum score above 9 in the third trimester and/or a previous history of trauma, anxiety and depression.
The NBO intervention group (n=30) will receive three home visits during the 2nd to 4th week after birth in addition to their usual home visits. The control group (n=30) will receive regular follow-up (without NBO sessions). At 4 months all participating mothers will be videotaped during daily caring, feeding or play episodes with their infant.
Baseline questionnaire (T1) contained information on household income, parity, education level and the number of children living in the household. Maternal depressive symptoms were measured by the Icelandic version of The Edinburgh Postnatal Depression Scale (EPDS) at 24-28 weeks of gestation (T0), six weeks postpartum (T5) and again at 4 months postpartum (T6). The EPDS is a 10-item self-report scale that assesses current (last week) postpartum depressive symptomatology. Each item is rated on a 4-point scale (0-3), yielding a total score ranging from 0 to 30, with higher scores indicating increased symptomatology of postpartum depression.
The videos will be coded by use of the The Emotional Availability (EA) Scale to assess maternal sensitivity and Childs responsiveness. The EA Scale consists of six dimensions of emotional availability in the relationship: four for the adult (sensitivity, structuring, nonintrusiveness and nonhostility) and two for the child (responsiveness to adult and involvement of adult). The EA direct score for the first dimension, sensitivity for mothers and responsiveness for the child, is reported. The score seven (range 1-7) is the highest/best possible score on the two first catagories and three (range 1-3) is the higest/best score fot the next five catargories. This seven catagories in each domain make the direct score, witch can reach from 7-29 where the 29 is the higest. In addition to the 6 diementions the Clinical Screeners....... The EA Scale is validated in various settings and cultures and will serve as the main outcome measure in the RCT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mother-Infant Interaction
Keywords
perinatal depression, maternal sensitivity, Infant emotion regulation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBO intervention for at-risk mothers
Arm Type
Experimental
Arm Description
NBO intervention for at- risk mothers. 3 NBO sessions added to the routine follow-up delivered once per week during the first month postpartum. The intervention is delivered by a nurse certified in the NBO system.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants receive 3 routine follow-up by the local health visitor/midwife during the first month
Intervention Type
Behavioral
Intervention Name(s)
The Newborn behavioral observations system
Intervention Description
The NBO system is a relationship building tool to enhance parental sensitivity in the newborn period. Mothers at risk for post-partum depression are supported by a clinician to respond with confidence to their newborn's individual needs.
Primary Outcome Measure Information:
Title
Maternal sensitivity
Description
Maternal sensitivity is measured in the dyad of mother-infant communication; as appropriate responsiveness and ability to handle conflicts in the relationship. Scores for each subscale range from 1-7, higher scores indicating more sensitivity. Direct score range from 7-29, higher scores indicate more sensitivity. Direct score leads to Clinical-Screener score which is reated on a 100 point dimentional scale, divided into four zones; Emotional-Availability (81-100), Complicated E-A (61-80), Unavailable/Detached E-A (41-60) and Problematic/disturbed E-A (1-40).
The EA Scale is validated in various settings and cultures and will serve as the main outcome measure in the RCT.
Time Frame
Maternal sensitivity will be measured 3 months after the third NBO session at infant ages 4 months
Title
Childs responsiveness
Description
Childs responsiveness is measured in the dyad of mother-infant communication; as willingness to respond to bids of the adult without over-compliance. Scores for each subscale range from 1-7, higher scores indicating more responsivenss. Direct score range from 7-29, higher scores indicate more responsiveness. Direct score leads to Clinical-Screener score which is rated on a 100 point dimentional scale, divided into four zones; Emotional-Availability (81-100), Complicated E-A (61-80), Unavailable/Detached E-A (41-60) and Problematic/disturbed E-A (1-40)
Time Frame
Childs responsiveness will be measured 3 months after the third NBO session at infant ages 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant women and their partners
Age of 18 or more.
Understanding Icelandic.
Having score of EPDS scale of more than 9 or history of depression and/or anxiety
Exclusion Criteria:
Not speaking or understanding Icelandic.
Having given birth within 35 weeks of pregnancy.
Having a sick baby
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna M Jonsdottir, PhD
Organizational Affiliation
team leader
Official's Role
Study Director
Facility Information:
Facility Name
Stefanía Birna Arnardóttir
City
Reykjavík
State/Province
Ísland
ZIP/Postal Code
110
Country
Iceland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of the Newborn Behavioral Observations System on Maternal Sensitivity
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