Mother-Infant InteractionNCT04739332
The Effect of the Newborn Behavioral Observations System on Maternal Sensitivity
A study testing The Newborn behavioral observations system in people with Mother-Infant Interaction, run by Center for Parents and Infants, Iceland at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mother-Infant Interaction
- What is being tested?
- The Newborn behavioral observations system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIceland
- Study dates
- 1 Jul 2016to 17 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not speaking or understanding Icelandic.
- Having given birth within 35 weeks of pregnancy.
- Having a sick baby
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effect of the Newborn Behavioral Observations System on Maternal Sensitivity Four Months Post-partum
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.
Read the 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.
- Conditions
- Mother-Infant Interaction
- Being tested
- The Newborn behavioral observations system
- Keywords
- perinatal depression, maternal sensitivity, Infant emotion regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Newborn behavioral observations systemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| NBO intervention for at-risk mothers | Experimental | 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. Receives: Behavioral: The Newborn behavioral observations system |
| Treatment as usual | No intervention | Participants receive 3 routine follow-up by the local health visitor/midwife during the first month |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Maternal sensitivity will be measured 3 months after the third NBO session at infant ages 4 months
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)
Measured: Childs responsiveness will be measured 3 months after the third NBO session at infant ages 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Jul 2016
- Primary completion1 Jul 2018
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mother-Infant InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Parents and Infants, Iceland
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Stefania Birna Arnardottir, Center for Parents and Infants, Iceland
- Investigators
- Anna M Jonsdottir, PhD, Study director, team leader
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739332
- Sponsor's protocol ID
- CParentsInfants
- Status last verified
- Feb 2021
- First submitted
- 17 Dec 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valla L, Slinning K, Wentzel-Larsen T, Rosand GM, Arnardottir SB. The newborn behavioural observations (NBO) system embedded in routine postpartum care in at-risk families in Iceland: a randomised controlled trial. BMC Pregnancy Childbirth. 2025 Jan 8;25(1):13. doi: 10.1186/s12884-024-07128-0.
PubMed 39780054
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of the Newborn Behavioral Observations System on Maternal Sensitivity Four Months Post-partum
- ClinicalTrials.gov ID
- NCT04739332
- Acronym / sponsor ID
- CParentsInfants
- Conditions
- Mother-Infant Interaction
- Keywords
- perinatal depression, maternal sensitivity, Infant emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Center for Parents and Infants, IcelandUniversity, hospital or other
- 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
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| NBO intervention for at-risk mothers | Experimental | Behavioral: The Newborn behavioral observations systemNBO 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. |
| Treatment as usual | No intervention | –Participants receive 3 routine follow-up by the local health visitor/midwife during the first month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Not speaking or understanding Icelandic.
- Having given birth within 35 weeks of pregnancy.
- Having a sick baby
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Newborn behavioral observations systemThe 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. | Behavioural | NBO intervention for at-risk mothers |
Primary outcome
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 39780054Valla L, Slinning K, Wentzel-Larsen T, Rosand GM, Arnardottir SB. The newborn behavioural observations (NBO) system embedded in routine postpartum care in at-risk families in Iceland: a randomised controlled trial. BMC Pregnancy Childbirth. 2025 Jan 8;25(1):13. doi: 10.1186/s12884-024-07128-0.
- Individual participant dataSharing planned: No
Related trials for Mother-Infant Interaction
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
Active, not recruiting
Investigating Baby Behavior and Family Technology Use Study
Mobile Phone Use, Mother-Infant Interaction
Recruiting
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
Postpartum Depression, Postpartum Anxiety
Recruiting
The Effect of the Cesarean ERAS Protocol on Mother-Infant and Father-Infant Bonding: a Multicenter, Randomized Controlled Clinical Trial.
Bonding, ERAS
Recruiting
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
Preterm Birth, Mother-Infant Interaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna M Jonsdottir, PhD study director
team leader
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Newborn behavioral observations system in people with Mother-Infant Interaction, run by Center for Parents and Infants, Iceland at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal sensitivity (time frame: Maternal sensitivity will be measured 3 months after the third NBO session at infant ages 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04739332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.