Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-28 @ 4:20 AM
Study NCT ID:
NCT04739332
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2020-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Newborn Behavioral Observations System on Maternal Sensitivity
Sponsor:
Center for Parents and Infants, Iceland
Organization:
Study Overview
Official Title:
Assessing the Effect of the Newborn Behavioral Observations System on Maternal Sensitivity Four Months Post-partum
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: