The Effect of the Newborn Behavioral Observations System on Maternal Sensitivity

NCT04739332 | Completed

• 1 other identifier: CParentsInfants
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mother-Infant Interaction

Keywords

perinatal depression; maternal sensitivity; Infant emotion regulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  Childs responsiveness will be measured 3 months after the third NBO session at infant ages 4 months

Study Arms (2)

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.

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

Interventions

The Newborn behavioral observations system 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.

NBO intervention for at-risk mothers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not speaking or understanding Icelandic.
• Having given birth within 35 weeks of pregnancy.
• Having a sick baby

Sponsors & Collaborators

• Center for Parents and Infants, Iceland: lead
• The Icelandic Nurses' Association: collaborator
• Health care of the capital area, Iceland: collaborator
• Research and Analysis, v/University of Reykjavik: collaborator
• Regionsenter for barn og unges psykiske helse, Norway: collaborator

Study Sites (1)

Stefanía Birna Arnardóttir

Reykjavik, Ísland, 110, Iceland

Location

Related Publications (1)

• 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.

  PMID: 39780054 DERIVED

Study Officials

• Anna M Jonsdottir, PhD

  team leader

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family nurse specialist, MSc

Model Details: RCT

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: February 4, 2021
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: October 17, 2019
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)