The Effect of the Newborn Behavioral Observations System on Maternal Sensitivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2019-10-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mother-Infant Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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NBO intervention for at-risk mothers

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.

Group Type EXPERIMENTAL

The Newborn behavioral observations system

Intervention Type BEHAVIORAL

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.

Treatment as usual

Participants receive 3 routine follow-up by the local health visitor/midwife during the first month

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The Newborn behavioral observations system

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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