- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04739332
The Effect of the Newborn Behavioral Observations System on Maternal Sensitivity
Assessing the Effect of the Newborn Behavioral Observations System on Maternal Sensitivity Four Months Post-partum
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ísland
-
Reykjavík, Ísland, Iceland, 110
- Stefanía Birna Arnardóttir
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
|
NO_INTERVENTION: Treatment as usual
Participants receive 3 routine follow-up by the local health visitor/midwife during the first month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal sensitivity
Time Frame: Maternal sensitivity will be measured 3 months after the third NBO session at infant ages 4 months
|
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. |
Maternal sensitivity will be measured 3 months after the third NBO session at infant ages 4 months
|
Childs responsiveness
Time Frame: Childs responsiveness will be measured 3 months after the third NBO session at infant ages 4 months
|
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)
|
Childs responsiveness will be measured 3 months after the third NBO session at infant ages 4 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Anna M Jonsdottir, PhD, team leader
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CParentsInfants
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mother-Infant Interaction
-
Antalya Bilim UniversityCompletedSleep | Yoga | Newborn | Mother-Infant InteractionTurkey
-
Istanbul University - Cerrahpasa (IUC)Not yet recruitingSleep Quality | Mother-Infant Interaction | AttachmentTurkey
-
California Polytechnic State University-San Luis...RecruitingBreastfeeding | Bottle Feeding | Mother-Infant InteractionUnited States
-
Halic UniversityGülçin BozkurtRecruitingNewborn; Vitality | Mother-Infant Interaction | Theory, Double BindTurkey
-
National Taipei University of Nursing and Health...Recruiting
-
California Polytechnic State University-San Luis...University of Michigan; Parkview HealthRecruitingMobile Phone Use | Infant Development | Mother-Infant Interaction | Self-Regulation | Self-Regulation, EmotionUnited States
-
University Hospital, GenevaTerminatedMother-Infant InteractionSwitzerland
-
Hasan Kalyoncu UniversityCompletedMother-Infant InteractionTurkey
-
Istanbul University - Cerrahpasa (IUC)Active, not recruitingMother-Infant InteractionTurkey
-
University of CologneCompletedMother-Child InteractionGermany
Clinical Trials on The Newborn behavioral observations system
-
University Hospital, MontpellierUnknown
-
University of TromsoUniversity Hospital of North Norway; Public Health Sisters in the Tromsø municipalityCompleted
-
Brigham and Women's HospitalChild TrendsCompletedPostpartum Depression | Infant Development | Preterm InfantUnited States
-
University of AarhusCompletedParent-Child RelationsDenmark
-
Sakarya UniversityNot yet recruitingBreast Feeding | Breast Milk Collection
-
Centre Hospitalier Universitaire, AmiensCompletedMother-Child Relations | MaternityFrance
-
University of BorasVastra Gotaland Region; Netherlands Instititute for Health Services Research; Mälardalen UniversityRecruiting
-
Hospices Civils de LyonCompletedSickle Cell Disease | Infant, Newborn, Disease | DrepanocytosisFrance
-
Centre Hospitalier Universitaire de Saint EtienneL'École Nationale des Solidarités, de l'Encadrement et de l'Intervention...RecruitingPsychiatric HospitalizationFrance
-
Centre Hospitalier Universitaire, AmiensCompletedPollution; Exposure | Newborn | Microbiota | Breast Milk | Meconium | Pesticide | StoolFrance