Clinical trial NCT04739332: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mother-Infant Interaction
Keywords: perinatal depression
maternal sensitivity
Infant emotion regulation
Lead sponsor: Center for Parents and Infants, Iceland
Sponsor class: OTHER
Collaborators: name: The Icelandic Nurses' Association
name: Health care of the capital area, Iceland
name: Research and Analysis, v/University of Reykjavik
name: Regionsenter for barn og unges psykiske helse, Norway
First posted: 2021-02-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Maternal sensitivity
timeFrame: Maternal sensitivity will be measured 3 months after the third NBO session at infant ages 4 months
measure: Childs responsiveness
timeFrame: Childs responsiveness will be measured 3 months after the third NBO session at infant ages 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reykjavík
country: Iceland
facility: Stefanía Birna Arnardóttir
state: Ísland
Study officials:
affiliation: team leader
name: Anna M Jonsdottir, PhD
role: STUDY_DIRECTOR
References: