Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03836430 |
| Other study ID # |
2018P001771 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
May 5, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Brigham and Women's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Preterm birth is a serious public health issue, affecting 10% of all births in the US alone.
Three quarters of these infants are born between 34 0/7 and 36 6⁄7 weeks' gestation or
late-preterm (LP). Mothers of LP infants are at increased risk for postpartum stress,
depression and mother-infant interaction problems posing significant risks for infant
development. Our proposed project will advance the fields of maternal and child health by
examining the impact of the Newborn Behavioral Observations Family Wellness (NBO-FW), a
dyadic, two generational intervention targeting maternal wellbeing and early mother-infant
relations in families of LP born infants. The NBO-FW is a 12week preventative intervention
aimed at promoting maternal mental health and positive parenting. It is based on the highly
successful NBO intervention developed by our team and applied across five continents, but
with important new elements targeting maternal mental health and the needs of high-risk LP
infants and their families. Participants will consist of 200 first-time mothers and their LP
infants (100 intervention and 100 control dyads) born at Brigham and Women's Hospital (BWH),
an urban teaching hospital of Harvard Medical School and the largest maternity care provider
in Boston. Data will be collected at three time points: during the birth hospitalization, at
a follow-up visit at 4-6 weeks corrected gestational age, and at a further visit 10-12 weeks
after birth. Outcomes will include standardized measures of maternal stress, depression,
parenting confidence, and observed mother-infant interaction. Information about infant health
care practices and maternal/infant health will also be recorded. We hypothesize that,
compared to mothers in the care as usual control group, first-time mothers of LP infants who
receive the NBO-FW will demonstrate a) lower levels of stress and depression, b) greater
parenting confidence, c) higher quality interactions with their infants (e.g., positive
affect, sensitivity, responsiveness, emotional connection); and (d) engage in more optimal
infant health care practices.
Description:
Preterm birth is a serious public health issue, affecting 10% of births in the US alone. The
vast majority of these infants are born between 32 and 37 weeks of gestation and are at
increased risk of neurodevelopmental problems. The mothers of these infants are also at
increased risk for postpartum stress, depression and mother-infant interaction problems which
can further exacerbate child risks. Specific maternal and family challenges include
mother-infant emotional disconnection, less sensitive maternal care behavior, and reduced
engagement in healthy infant care practices such as breastfeeding.
To date, relatively little attention has been given to addressing the needs of preterm born
(>32 and <37 weeks of gestation) infants and their families, with most research focusing on
the very and extremely preterm born infant. As a result, there are few to no interventions
that specifically: a) address the needs of the preterm infant and their caregivers; b) offer
parent education; c) foster a close mother-infant relationship; and d) seek to provide
support and empowerment of mothers. This stands in contrast to an extensive body of
experimental and human infant research showing that early mother-infant contact is essential
for both maternal wellbeing and offspring development, with disruptions to this early
relationship having lifelong negative effects for the infant.
This research project meets this important gap, with the goal of advancing the fields of
maternal and child health by examining the impact of a dyadic two-generation, Newborn
Behavioral Observations-Family Wellness (NBO-FW) intervention on early maternal wellbeing and
mother-infant relations in families of preterm born infants.
There is now good evidence to support the importance of early intervention as a preventative
strategy to reduce the risks of longer term development problems in both typically developing
and high-risk populations of mothers and infants. Intervening early with young children who
are at risk for developmental delay has been shown to positively impact children's
developmental outcomes across multiple functional domains, spanning health, language,
cognitive and social-emotional development. In addition, families benefit from early
intervention because it can increase their ability to understand and meet their child's
needs, as well as mitigate stressors that may be adversely impacting maternal wellbeing, the
mother-infant relationship and in turn, healthy child development.
Original Newborn Behavioral Observation Intervention The original NBO developed here in
Boston by Kevin Nugent and colleagues is an interactive observational tool used by clinicians
to strengthen the relationship between parents and infants from birth to age 3 months, or
even longer in the case of the at-risk infant. As such, it is a flexible, short-term,
family-centered early intervention strategy that is suitable for use and widely used in
newborn units, the Neonatal Intensive Care Unit (NICU), obstetric, pediatric, and other
primary care settings.
During an NBO session, a certified clinician and parent observe the newborn together for
about 15-20 minutes. The focus is on 18 neurobehavioral items designed to capture the
infant's visual, auditory, and perceptual abilities used by the infant to explore their world
and engage in mutually responsive face-to-face interaction. These items include observations
of the infant's capacity to habituate to external light and sound stimuli (sleep protection);
the quality of motor tone and activity level; the capacity for self-regulation (including
crying and consolability); response to stress (indices of the infant's threshold for
stimulation such as color change, startles and tremors); and the infant's visual, auditory,
and social-interactive capacities (degree of alertness and response to both human and
non-human stimuli). The original NBO is now used widely as a clinical tool throughout Europe,
Australasia, Asia, Africa, and North America.
Existing data from evaluations of the NBO dyadic intervention demonstrate positive impacts on
both maternal postpartum depression risk and the quality of mother-child interactions in
depressed mothers and preterm infants hospitalized in the NICU. Although it's effectiveness
with first-time mothers and their late preterm infants has not been evaluated, there is some
support for its utility. Specifically, Nugent and Bartlett have conducted a randomized
controlled trial (RCT) with first-time mothers and their full-term born infants (n = 106) in
hospital and home settings. They found that the NBO was associated with a 75% reduction in
maternal symptoms of depression one month after birth. A second smaller RCT study by the same
authors (n = 35) with mothers and their full-term infants, also showed that mothers who
received an NBO intervention were 2.5 times more likely to be rated as sensitive caregivers
than non-intervention control mothers. Their infants were also observed, in turn, to be 2.8
times more responsive to their mothers, suggesting a stronger mother-infant connection.
Finally, the NBO has been linked with increased maternal parenting confidence, enhanced
interactions between mothers and their high-risk newborns, and increased parental knowledge
of infant behaviors and competencies across a range of high risk populations.
Our Enhanced Newborn Behavioral Observation - Family Wellness (NBO-FW) Intervention:
In collaboration with Nugent and Bartlett, we have developed an extended NBO intervention.
This new intervention termed the Newborn Behavioral Observation - Family Wellness (NBO-FW)
approach builds on the strengths of the NBO but includes additional resources and strategies
to promote parental wellbeing and mental health, as well as greater parental self-reflection
on their infant and themselves as parents aimed at helping new mothers of a preterm born
infant bond with their baby, feel better about themselves, and to be a more confident and
competent parent.
This new NBO-FW approach is a 12-week preventative intervention that will consist of 1-2
in-person NBO-FW session in the hospital followed by a tele-health follow-up visit and a
third outpatient in-person NBO-FW session with a trained and NBO certified therapist. These
visits will be supplemented by the use of a parental self-reflection guide between sessions
to maintain maternal engagement in the intervention and to further foster the dyads progress
in understanding each other. All therapy sessions will be completed by an appropriately
qualified mental health/early intervention professional trained and supervised by Kevin
Nugent and Lise Johnson.
Against this background, the overall objective of this research project is to examine whether
the Newborn Behavioral Observations-Family Wellness (NBO-FW) intervention leads to better
maternal mental health, healthier mother-infant interactions, parenting confidence, and
better infant health care practices in new mothers giving birth to a preterm born infant.
The proposed project aims to advance understanding of how to intervene successfully to
improve postpartum maternal mental health, parent-child relations, and mothers' infant health
care practices in high risk families. The strategy, methodology, and data analyses used to
accomplish these aims are based on evidence generated from the first RCT studies conducted by
Drs. Nugent, Bartlett, and colleagues. As such, the NBO-FW intervention has the potential to
fulfill an important unmet need in supporting parents and their high-risk newborns in the
early days and weeks of life. Potential benefits to patients will include additional
assessments of their infant's health and wellbeing, as well as additional individualized
support in hospital and during their transition to home. More broadly, study findings will
advance knowledge about how best to improve outcomes for future preterm infants and families.
There are multiple strengths and unique qualities of the NBO-FW intervention that support its
chances of research and clinical success. These include:
- Positive adaptive model. Rather than being based on a deficit model of illness, the
NBO-FW is based on a positive adaptive developmental model that has been shown across a
number of studies to help mothers learn to understand and care for their newborns.
- Critical time of opportunity. The birth of a child is one of the most important
normative crises of life. New mothers may be uniquely open to change and support in the
first days and weeks in ways that do not necessarily persist once the adjustments -
positive or negative - to life with their new baby have been made and caregiving
patterns are established. Appropriate for use within the first days following birth, the
NBO-FW leverages this opportunity to its greatest potential.
- Efficient, short term intervention timed to coincide with routine medical care. The
NBO-FW intervention is an efficient, cost-effective tool for addressing the common
condition of postpartum stress and depression, as well as fostering positive parenting
and infant health care practices. The NBO-FW intervention can be completed with a
limited number of encounters over the first 4-6 weeks of life and is designed so that it
can be implemented in tandem alongside routine clinical care.
