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The Effect of a Newborn Behavioral Observation System-Early Intervention (NBO-EI) Model of Care. In collaboration with Kevin Nugent (PI), Children’s Hospital, Boston
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RESEARCH ARTICLE
KEYWORDS
cognitive function, developmentally supportive care, early intervention, high-risk newborns,
NBO, parent–infant communication, parent–infant interaction, relationship-based care, self-
regulation, social–emotional function
Infant Ment Health J. 2020;1–13. wileyonlinelibrary.com/journal/imhj © 2020 Michigan Association for Infant Mental Health 1
2 MCMANUS et al.
interaction, create care plans and goals to bolster parent– ship, the cornerstone of optimal infant neurodevelopment
infant functioning, and adequately support parents and function (Feldman, 2009; Fonagy, 2002; Kalland et al.,
and high-risk infants (Figure 1). A developmental or 2016). In sum, the NBO is a relationship-based intervention
relationship-based care model is strength-based and is that could serve as a new standard of care.
primarily guided by the principle that the quality of early Because the newborn period is a time of particular
experiences drives brain development and functional vulnerability for both parents and their infants, PPD
outcomes. Given that all experiences have meaning for can impair a mother’s ability to respond contingently to
infants and parents, it is crucial that EI providers develop her infant’s cues and to engage in sensitive and respon-
an appreciation for the encounter with the infant as one sive interactions with her infant (Mertesacker, Bade,
that contributes to his or her brain development at any Haverkock, & Pauli-Pott, 2004; Murray et al., 2016; Musser,
given time. Another reason that a relationship-based Ablow, & Measelle, 2012; Tronick, 2007). The NBO is based
model of care is not yet implemented as the standard of on the assumption that newborns have a rich repertoire of
care in EI today is the dearth of literature on relationship- social responses and rudimentary intentions and emotions
based models of care embedded in “real-world” EI that are evolutionarily designed to draw out parental care-
practice. giving and thus ensure the infant’s survival and develop-
The Newborn Behavioural Observations system (NBO) ment (Brazelton & Nugent, 2011). The NBO is used there-
is a relationship-building intervention that focuses on fore to sensitize parents to their infant’s social cues, in
bolstering parent–infant interaction and coregulation order to engage the caregiver and motivate the kind of con-
(Nugent, Keefer, Minear, Johnson, & Blanchard, 2007). tingent parent–infant interactions deemed essential not
Specifically, the NBO involves a set of shared observations only for the baby’s survival but for the establishment of
of the infant with the parent, which includes a series of secure attachments and healthy development. Thus, for
maneuvers used to (1) elicit infant neurobehaviors and (2) mothers who are depressed, the baby can be a powerful cat-
describe and interpret these neurobehaviors in the context alyst for growth and positive change, because the newborn
of the parent–infant interaction and infant self-regulation infant has the emerging capacity for shared attentiveness
and intentions. This interactive approach is designed to and social engagement.
promote mentalization or parental reflective functioning, In our previous work, we found that the NBO was
by enabling the parent to think about and understand associated with reduced PPD symptoms in mothers of
their child’s feelings and experiences and see the child as healthy term infants (Nugent, Bartlett, & Valim, 2014),
an individual, thus enhancing the parent–infant relation- while Shah (2018) reported that the NBO was effective in
4 MCMANUS et al.
ameliorating maternal perinatal anxiety symptoms in a ents received Institutional Review Board approved mate-
sample of women diagnosed with anxiety during preg- rial about the study from their EI service provider. Parents
nancy. Previous literature also suggests that the NBO who agreed to participate completed written informed con-
promotes parents’ ability to read their infant’s cues (Dittz, sent forms with a member of the study team, and infants
Alves, Duarte, & Magalhães, 2017; Guimarães, Lindgren were randomly assigned using cluster randomization pro-
Alves, Cardoso, Penido, & de Castro Magalhães, 2017; cedures (i.e., randomized within EI program) to receive the
McManus & Nugent, 2014; Simkin-Tran, Harman, & NBO intervention or usual care (UC) EI. Specifically, the
Nicolson, 2020) and improve provider confidence to work study lead researcher created a blocked random list (Sealed
with medically fragile newborns (Kristensen, Vinter, Envelope Ltd. 2016. Create a blocked randomisation
Nickell, & Kronborg, 2019; McManus & Nugent, 2011). In list. [Online] Available from: https://www.sealedenvelope.
a nonrandomised cluster-controlled design, Høifødt et al. com/simple-randomiser/v1/lists [AccessedMay 16, 2016]
(2020) found that in a well-functioning, well-educated including the five EI sites (i.e., blocks) and allowing for bal-
sample of mothers of full-term infants, mothers learned ance between the study arms. The sample size calculation
significantly more from the follow-up about the baby’s was performed in SAS v9.4 and estimated that 15 infants
signals and needs in relation to sleep/wake patterns, per group would allow detection of clinically meaningful
social interaction, and crying/fussiness, but the NBO was differences in the outcome measures of interest with 80%
not associated with lower levels of depressive symptoms power. Study infants were followed for up to 6 months,
and parenting stress at 4 months postpartum. Yet, to our corrected gestational age, with outcome measurements
knowledge, the long-term effects of the NBO on infant (described below) at EI entry, 3-months corrected age, and
neurodevelopment in at-risk infants and their families 6-months corrected age.
remain to be evaluated. Thus, more information is needed
about the long-term effects of the NBO on maternal
emotional well-being, particularly with families of infants 2.2 NBO intervention
at risk for developmental delays.
In this pilot study, we describe a study designed to The NBO is a shared observation of the infant with the
address the current knowledge gap on the effects of the parents and provider that is designed to elicit the infant’s
NBO as an infant mental health intervention on infant responses and regulatory abilities through the administra-
and maternal outcomes. The aims of this study were to tion of items that involve infant handling and social inter-
test the effectiveness of the NBO as a model of care on action. The NBO session typically begins with an obser-
infant neurodevelopment, with a particular focus on cogni- vation of the baby’s initial state. If the baby is asleep, the
tive and social development and on symptoms of maternal clinician (or parent) then administers the light and sound
depression. Understanding effective strategies to improve stimuli to observe the infant’s capacity for sleep protection
self-regulatory difficulties in high-risk infants has impor- (i.e., habituation). When the baby becomes more alert,
tant clinical and programmatic implications for designing the clinician then elicits—or guides the parents to elicit—
and implementing developmentally supportive interven- motor behaviors such as hand-grasp, sucking and root-
tions for infants and toddlers. ing, pull-to-sit, and crawling. The quality of motor tone
and activity level is observed, followed by observations
of the infant’s capacity to respond to the face and voice
2 METHODS and inanimate visual (red ball) and auditory stimuli (rat-
tle) and the opportunity to engage in a face-to-face inter-
2.1 Population and recruitment action with parent and or clinician. If the infant cries,
the amount of crying and the ease or difficulty of con-
The study sample was drawn from five EI programs in solability is observed while particular attention is paid to
Massachusetts. Most of these programs serve low-income, the infant’s threshold levels and signs of stress throughout
underserved communities. Children were enrolled in the the NBO session. The 18 observed or elicited items high-
study if they were less than 6 weeks old (corrected for ges- light the robustness of infants’ physiologic (e.g., observing
tational age), eligible for EI services based upon medical color changes, tremors, and startles), motor (e.g., flexion
and social factors, and had a primary caregiver over the age recoil), state regulation (e.g., observing frequency and pre-
of 18 who spoke or wrote English, Spanish, or French flu- dictability of state transitions), and social interaction func-
ently (as materials were available only in these languages), tion (e.g., visual or auditory responses to animate or inan-
and resided with their biological parent. The EI program imate stimuli). Items are recorded on a three-point scale
director identified eligible infants and caregivers between reflecting the degree of the infants’ robustness with the
February 1, 2016 and August 31, 2016. All eligible par- observed or elicited activity. During the NBO, EI providers
MCMANUS et al. 5
and parents engage in a shared observation in order cognitive and social–emotional function and (b) symptoms
to develop an understanding of the infant’s strengths of maternal depression.
and needs for support in the context of the parent– Infant neurodevelopment was measured using scaled
infant relationship. At the end of the NBO encounter, (i.e., age-adjusted) scores from two different instruments,
the provider and parent reflect on the shared observation the Bayley Scales of Infant Development-III (BSID-III)
and jointly develop strategies to assist the infant in bol- Adaptive and Social Emotional Scales (Bayley, 1993) and
stering self-regulation and to promote the parent–infant the full Batelle Developmental Inventory, second edition
relationship. (BDI-2: Newborg, 2005).
BSID-III. The BSID-III is a widely used assessment of
function appropriate for children ages 1–42 months, and
2.3 Procedures items are scored dichotomously (1 = able to complete or
0 = not able to complete). For this study, we used the BSID-
NBO home visits typically consist of intervention strate- III Adaptive Scale which includes seven subscales relevant
gies guided by the NBO. At each home visit, the EI ser- to newborns: Communication (e.g., makes eye contact,
vice provider conducted the NBO with the parents and laughs, cries when upset), Health (e.g., cries when upset,
discussed (1) the infant’s attempts and successes at self- swallows liquid medicines, avoids bumping into things
regulation and signals for support, (2) how the infant’s when mobile), Leisure (e.g., engaging with a toy, looking
neurobehaviors contribute to the parent–infant social at a picture in a book), Self-Care (e.g., feeds/swallows well,
interactional encounter, parental meaning-making, and sleeps through the night), Self-Direction (e.g., focuses on
infant–caregiver bonding. To improve intervention fidelity, a toy, calms when picked up), Social (e.g., smiles, snug-
NBO interventionists and site directors attended a 2-day gles, lifts arms to be picked up), and Motor (e.g., lifts head,
advanced NBO training course prior to the start of the shakes a rattle). Additionally, we used the BSID-III Social
study. The course reviewed details on recruitment and Emotional Scale. Specifically, we used the 3-month and 6-
informed consent procedures, the intervention protocol to month modules which assess self-regulation skills and use
ensure standardized delivery of the intervention, and data of emotions in an interactive, purposeful manner, respec-
collection procedures. Both off-site and on-site mentoring tively. Specific items include infant’s ability to calm, engage
of NBO interventionists was made available including con- with an adult, respond to touch, and voice. The BSID-III
ference calls and webinars. Adaptive and Social Emotional Scales were administered
Infants in the intervention group received weekly home via phone interview at the 3-month and 6-month follow-
visits from an EI provider certified in the NBO system, up time, by an independent member of the study team who
which was used up to 12 weeks corrected gestational age. was blinded to the infant’s intervention group assignment.
The UC group received traditional EI home-based ser- BDI-2. The BDI-2 is appropriate for children birth to 7
vice delivery from an EI provider not certified in the years of age and includes five subscales that evaluate the
NBO. These home visits typically consist of therapeutic core developmental domains of adaptive, motor, commu-
and developmental activities deemed appropriate for the nication, personal–social, and cognitive function. BDI-2
infant’s adjusted age and typically include visual track- items are scored on a three-point scale to capture emerg-
ing, reaching and grasping toys of a variety of textures, ing functional performance (Bliss, 2007). The BDI-2 has
and tolerance of developmental play. Infants in both treat- been shown to have good sensitivity and specificity to clas-
ment arms received at least three 1-hr study visits and some sify infants and toddlers with developmental delay and to
infants received four. be a valid measure of change in developmental function
To minimize bias, providers were selected into the UC over time (Elbaum, Gattamorta, & Penfield, 2010). Since
and NBO groups to have similarity in terms of professional the study programs used the BDI-2 for EI eligibility pur-
discipline, education, and years of experience. In our previ- poses, study providers completed the BDI at EI entry and
ous pilot NBO research, we observed minimal differences 6-months (corrected for gestational age) per EI protocol
across provider groups with regard to professional disci- and scores were sent to the research team. We used scaled
pline, years of experience, and education level (McManus BSID-III and BDI-2 scores, which both have a mean of 10
and Nugent, 2012). and a standard deviation of 3.
Maternal depressive symptoms were collected using the
Center for Epidemiologic Studies Depression Scale (CES-
2.4 Outcome variables D) (Radloff, 1977). The CES-D asks mothers to report, on
a four-point scale (0 = rarely/none of the time to 4 = all
The primary outcomes of interest were (a) infant’s neu- of the time), their frequency of symptoms for 20 scale
rodevelopment, with a focus on adaptive skills, and items. Scores of 16 or greater indicate clinically significant
6 MCMANUS et al.
2.5 Analysis
TA B L E 2 Unadjusted median (IQR) scores for each outcome measure at each time point for the NBO (n = 16) and Usual Care (n = 22)
infants
NBO (n = 16) Usual Care (n = 22)
Batelle Developmental Inventory
Subscale Scaled Scores EI entry 6-Months EI Entry 6-Months
Cognitive
Attention and Memory 2 [2, 2] 9 [9, 9] 2 [2, 4] 9 (0.1)
Perception and Concepts 6 [6, 8] 10 [10, 10] 8 [8, 9] 10 (0.1)
Adaptive/Behavioral
Adult Interaction 7 [7,7] 7 [4, 7] 7 [6, 8] 7 [7, 8]
Social Role 2 [2, 3] 9 [9, 9] 2 [2, 4] 9 [8, 9]
Communication
Expressive Language 6 [4, 6] 6 [5, 6] 6 [5, 6] 6 [6, 7]
Receptive Language 7 [6,8] 4, [4, 5] 7 [6, 8] 4 [2, 4]
Motor Skills
Fine Motor 5 [4, 6] 6 [6, 6] 5 [4, 6] 6 [5, 7]
Gross Motor 2 [2, 6] 8 [8, 8] 2 [2, 6] 8 [8, 8]
Self-Care 7 [6, 8] 8 [8, 9] 7 [6, 8] 8 [5, 8]
Bayley Scales of Infant Development
Subscale Scaled Scores 3 months 6 Months 3 months 6 Months
Communication 9 [8,9] 7 [6.5, 8] 8.5 [8,9] 7 [6,8]
Health 10 [9,10] 8 [7,9] 9.5 [7,10] 7 [6,8]
Leisure 10 [7,11] 8 [7,9] 10 [9,11] 9 [8,9]
Self-Care 6 [4,7] 4.5 [3.5,6] 4 [3,7] 5 [2,6]
Self-Direction 7 [7,9] 6 [4.5, 7.5] 8.5 [7,11] 7 [7,8]
Social 5 [5,6] 8 [5,8.5] 6 [5,6] 7 [5,10]
Motor 6 [5,7] 4.5 [4,5] 5.5 [5,7] 5 [4,7]
Social Emotional Skills 61 [54, 65] 70 [65,75] 59 [56, 64] 66 [63,70]
3 months 6 Months 3 months 6 Months
Centers for Epidemiologic 6 [5, 12] 3 [3, 9] 5 [2, 7] 3 [0, 4]
Studies-Depression
8 MCMANUS et al.
TA B L E 3 Unadjusted median (IQR) difference in CES-D, BSID-III, and BDI-2, scores between the NBO and Usual Care groups between
time points
Median change
NBO (n = 16) Usual Care (n = 22)
Batelle Developmental Inventory Subscalesa
Cognitive
Attention and Memory 7 [4, 7.5] 5 [3, 7]
Perception and Concepts 3.5 [2.5, 5] 1 [0, 3]
Adaptive/Behavioral
Adult Interaction –1 [–3, 5.2] 0 [–1, 2]
Social Role 6 [3, 5.7] 5.5 [4, 7]
Communication
Expressive Language 0 [–1.5, 2.5] 1 [–2, 2]
Receptive Language –3 [−4.5, −0.5] –3 [–4, –2]
Motor Skills
Fine Motor 1 [–0.5,4.5] 1 [–1, 4]
Gross Motor 5.5 [–0.5, 6.5] 3 [1, 6]
Self-Care 1.5 [–2, 3] 0 [−2, 3]
Bayley Scales of Infant Development Subscalesb
Communication –1 [−2, –1] –1 [–2, 0]
Health –2 [–3, –2] –2 [–2, 0]
Leisure –1 [−3, 0] −2, [−3, 0]
Self-Care 0 [–1, 1] 0 [–1,1]
Self-Direction –1 [–1, 0] –2 [–3, 0]
Social 2.5 [1, 4] 2 [0, 4]
Motor –1.5 [–3, –1] 0 [–1, 1]
Social Emotional Skills 9.5 [1, 13] 10 [3, 15]
c
Centers for Epidemiologic Studies-Depression –2.5 [−3, –1] –1 [–2, 1]
a
Differences in Battelle Developmental Inventory scores between EI entry and 6 months, adjusted for prematurity,
b
Differences in Bayley Scales of Infant Development scores between 3 and 6 months, adjusted for prematurity,
c
Differences in Centers for Epidemiologic Studies-Depression scores between 3-months and 6-months, adjusted for prematurity
postnatal depressive symptoms (b = −2.0 [−3.7, −0.3]) ple size and the results should therefore be interpreted
than the UC group (Table 5). accordingly.
Infants at risk for developmental delays and disabili-
ties due to medical and/or social factors are predisposed
4 DISCUSSION to have difficulties with self-regulation, which interrupts
successful integration of social, emotional, and cognitive
In this pilot pragmatic trial, we found that infants functions (Als et al., 2012, 2004; Blanchard & Mouradian,
who were randomized to receive the NBO, a stan- 2000; Blanchard & Oberg, 2015; Nugent, Blanchard, &
dardized, developmentally supportive, relationship-based Stewart, 2008). Thus, understanding self-regulatory diffi-
infant mental health intervention, every week during the culties in high-risk infants has important clinical and pro-
newborn period, had improved neurodevelopment at 6 grammatic implications for designing and implementing
months, and their mothers had greater improvement in developmentally supportive interventions.
postnatal depressive symptoms compared to parent–infant To this end, the first main finding of the paper is that
dyads receiving usual EI care. These findings are novel infants in the NBO group demonstrated greater gains cog-
because, to our knowledge, this is the first study to show nitive and adaptive function between EI entry and 6-
that the NBO can be an effective infant mental health inter- months post EI-entry. Specifically, infants receiving the
vention to bolster infant neurodevelopment and mater- NBO demonstrated better gains in visual attention with
nal well-being in “real-world” community-based EI set- caregivers (i.e., BDI-2 Attention and Memory) sensorimo-
tings. However, we acknowledge the small study sam- tor interactions (BDI-2 Perceptions and Concepts). Infants
MCMANUS et al. 9
T A B L E 4 Adjusteda median (95% CI) difference in CES-D and tings (Als et al., 1994, 2004, 2012). To our knowledge, the
BSID-III scores between the NBO and Usual Care groups at 3 current study is the first to demonstrate the positive infant
months neurodevelopmental effects of an infant mental health
Developmental outcome Median group intervention, the NBO, in “real-world” community-based
measure difference (95% CI) EI settings. The findings from this pilot study have the
Centers for Epidemiologic 0.82 [–2.2, 3.8] potential to improve EI service delivery and quality of life
Studies-Depression for families with infants at risk for developmental disabil-
Bayley Scales of Infant ities and delays. The significant findings around improved
Development Adaptive infant self-care after NBO intervention are particularly
Scale salient for quality of life improvement at an early age as
Social 0 [–0.62, 0.6] this subscale is closely related to feeding. Indeed, there is a
Communication 0 [–0.63, 0.63] significant body of literature (Thoyre, Hubbard, Park, Prid-
Health 0 [–1.23, 1.23] ham, & McKechnie, 2016; Thoyre, Park, Pados, & Hubbard,
Leisure 0.6 [–1.8, 3.0] 2013; Weber & Harrison, 2014) underscoring the impor-
Self-Care 0 [–3.1, 3.1] tance of relationship-based, developmentally supportive
Self-Direction 0.1 [–2.9, 2.8] care to promote optimal oral feeding skills in high-risk
newborns. It is likely that the NBO intervention effects on
Motor 1 [–.2, 2.2]
bolstering infant self-regulation and parent–infant interac-
Social Emotional Scale 0 [–2.9, 2.48]
tion had spillover effects on improving infant oral-feeding
a
Models adjusted for early intervention program.
skills.
*
p = 0.10.
The final main finding of this pilot study is that we
also found positive intervention effects for mothers sug-
receiving the NBO infant health intervention also demon- gesting that this individualized, developmentally support-
strated greater gains in their adaptive function. Specifi- ive relationship-based intervention has promising effects
cally, infants receiving the NBO infant mental health inter- at reducing symptoms of maternal depression and anxiety
vention showed greater improvements in eye contact with at 6 months post-EI entry. This finding is particularly pow-
caregivers, crying, using different voice tones to get care- erful because the mothers in the NBO group had much
givers’ attention (i.e., BSID-III Adaptive Scale, Communi- higher CES-D scores at the 3-month measurement. This
cation subscale), and feeding skills (i.e., BSID-III Adap- finding extends the results of another randomized con-
tive Scale, Self-Care subscale). Study findings are comple- trolled study of first-time mothers and their babies, which
mentary to previous literature examining the effect of the showed that the NBO was associated with lowering the
NBO. For example, the NBO has been shown to be asso- odds of depressive symptomatology by approximately 75%
ciated with improvements in parent’s ability to read their during the first month after delivery (Nugent et al., 2014).
baby’s cues [McManus & Nugent, 2014] and providers’ Because it is strength-based, can be easily integrated into
confidence to provide relationship-based, developmentally clinical practice and is cost-effective, the NBO could be an
supportive care to high-risk infants receiving EI services. effective intervention tool in preventing PPD in first-time
Arguably, parent–infant coregulation and provider confi- mothers. However, further research to determine whether
dence are mechanisms through which the NBO influences these effects hold up over time and explore underlying
infant cognitive, adaptive, and social function. The current mechanisms of the NBO’s effect on PPD will be important
study builds upon previous literature in confirming longer- to establishing the NBO’s effectiveness in reducing PPD
term neurodevelopmental effects of the NBO. symptoms.
There is growing research to support the role of This pilot study has important clinical, program-
relationship-based, infant mental health interventions like matic, and policy implications for developing a sustain-
the NBO on improving early self-regulatory difficulties able model of NBO-EI service delivery and serve as a
in high-risk newborns and later cognitive and social– research framework for other NBO studies. EI providers
emotional function (Figure 1). can use these findings to develop evidence-based care
These findings are promising in terms of the benefits of plans and intervention strategies to adequately address
the NBO as a mental health intervention in “real-world” early self-regulatory and parent–infant interactions dif-
community-based EI settings. State EI programs in the ficulties among the families with high-risk infants they
United States serve about 350,000 infants and their fami- serve. EI program directors and state EI leadership could
lies annually. The evidence supporting links between early consider implementing statewide education and train-
self-regulatory difficulties and later development and func- ing efforts related to infant mental health interven-
tion are derived from clinical research in controlled set- tions such as the NBO. Such training efforts could be
10 MCMANUS et al.
TA B L E 5 Adjusteda median difference (95% CI) in CES-D, BSID-III, and BDI-2, scores between the NBO and Usual Care groups between
time points
Developmental outcome measure Median group difference (95% CI) Effect size
Centers for Epidemiologic Studies-Depressionb –2.0 [–3.7, –0.3]a 0.50
c
Bayley Scales of Infant Development
Adaptive Scale
Social 0 [–2.4, 2.4]
Communication 1.0 [0.2, 1.8]a
Health 0 [–1.2, 1.2]
Leisure –1.0 [−2.8, 0.8] 0.33
a
Self-Care 2.0 [0.1, 3.9]
Self-Direction –1.0 [–3.4, 1.4]
Motor –2.0 [-–.8, –0.2]a 0.67
Social Emotional Scale –1.0 [–4.7, 2.7]
Battelle Developmental Inventoryd
Cognitive
Attention and Memory 3.0 [0.4, 6.0]* 1.0
Perception and Concepts 2.0 [0.4, 3.6]*a 0.67
Personal-Social
Adult Interaction –2.0 [–4.0, 0.04]
Social Role 1.5 [–0.8, 2.9]
Communication
Expressive Language –1.0 [–2.8, 0.8]
Receptive Language 0 [–1.2, 1.2]
Motor Skills
Fine Motor 1.0 [–0.4, 2.4]
Gross Motor 2.1 [–0.6, 4.8]
Self-Care 1.0 [–1.4, 3.4]
a
Models adjusted for early intervention program.
b
Differences in Centers for Epidemiologic Studies-Depression scores between 3 and 6 months, adjusted for prematurity.
c
Differences in Bayley Scales of Infant Development scores between 3 and 6 months, adjusted for prematurity.
d
Differences in Battelle Developmental Inventory scores between EI entry and 6 months, adjusted for prematurity.
*
p < .05.
incorporated into statewide quality assurance initiatives the ebbs and flows of high-risk infant EI referrals, the
to improve EI service delivery and outcomes for high- need to maintain openings on provider caseloads based
risk infants and their families. For example, the State upon randomization procedures, and provider turnover.
of Ohio has dedicated funding to train all EI develop- Yet, despite these logistical difficulties, we recruited a
mental specialists and infant mental health providers on sample that was adequately powered to detect significant
the NBO as a statewide approach to delivering evidence- (and clinically meaningful) group differences, using the
based infant mental health services to high-risk new- conservative standard error for p-value of .05. In addition,
borns and their families. Such statewide initiatives pro- we were able to implement a randomization protocol,
vide the opportunity for quality assurance activities and train providers to intervention fidelity, ensure that infants
evaluation of the reach and effectiveness of approaches, received approximately the same number of home visits
such as the NBO, on improving high-risk infant and within and across treatment arms, include additional out-
caregiver outcomes. come data collection with a researcher who was “blind” to
We acknowledge the study’s limitations. First, despite study group, and implement robust statistical procedures,
aggressive recruitment efforts, the overall sample size for despite the small sample size. Moreover, our results
the study was relatively small. This highlights a challenge suggest the NBO as an infant mental health intervention
with implementing and testing interventions in “real- implemented through EI programming has promising
world community-based settings.” The challenges include beneficial effects on infant neurodevelopmental function
MCMANUS et al. 11
and maternal well-being. If interventions such as the NBO opmental effects that extend to at least 6-months post-EI
were “scaled up” statewide, there would likely be multi- entry.
plier effects. A second limitation is that we did not include
a measure of parent–infant interaction or baseline (i.e., EI
entry postnatal depressive symptoms). Although the study 5 IMPLICATIONS/CONCLUSION
protocol included a measure of parent-infant interaction
assessed through a video-taped encounter, many parents Conducting outcomes research in EI is challenging due to
were not comfortable with being filmed. As a result, only the diversity of infants served by EI. In addition, it is dif-
about 45% participated in the videotaped parent–infant ficult to randomize infants to EI in order to obtain causal
interaction. We did, however, include a measure of social inferences about EI. In this pilot study, we used a multi-
competence through two social emotional outcomes site pragmatic trial design and robust methods to demon-
that, especially among young infants, are relational items strate the effectiveness of the NBO. This research built
and could serve as a proxy for parent–child interaction. upon previous work (McManus & Nugent, 2011, 2014) sug-
Indeed, collecting parent–infant interaction in real world gesting a positive influence of the NBO on parent’s ability
community-based settings is a challenge. Future research to read their baby’s cues and respond contingently and on
should explore avenues for assessing parent–infant EI providers’ confidence in working with high-risk fami-
interaction through modalities and approaches that are lies. Thus, the results of this pilot study have contributed to
acceptable to parents. Finally, we only followed infants the evidence for making relationship-based care the stan-
and families for 6-months, which limits our ability to dard of care in EI settings.
draw conclusions about later development and school Developmental, relationship-based care is associated
readiness. Future research should consider following with improved infant quality of life and maternal well-
children until EI exit or through preschool to determine being (Als et al., 1994, 2004, 2012; Kalland et al., 2016;
long-term neurodevelopmental effects of infant mental McKelvey et al., 2015; McManus & Nugent, 2011; Nelson
health interventions such as the NBO delivered in the et al., 2019; Nugent et al., 2014). The results presented
newborn period. here show that NBO has a strong potential to promote
maternal well-being and foster caregiver–infant bonding
by reducing maternal depressive symptoms, improving
4.1 Strengths early cognitive and social–emotional function for infants
with developmental disabilities and delays, thus creating
Despite these limitations, this pilot study has a number of a sustainable model of EI service delivery that supports
strengths. Study infants were randomized to their treat- parents of high-risk infants. Future research should focus
ment arms and received similar intervention dosage and on continuing to follow these families to evaluate the
follow-up, which highlights the rigor of this pilot study. longer-term effects of the NBO–EI model of care, which
Additionally, it is the first study to evaluate the effect of may have important implications for toddlers and school
an infant mental health intervention, the NBO, in an EI readiness.
setting. Additionally, a number of outcome measures were
collected to capture a full battery of infant neurodevelop- AC K N OW L E D G M E N T S
mental function. To this end, state-mandated EI outcome Drs. Nugent, McManus, and Blanchard acknowledge
measures were integrated to reduce provider and parent funding from the Noonan Medical Foundation. All authors
burden and to increase the feasibility and generalizabil- wish to acknowledge Patti Fougere and Steve McCourt
ity of our results. The infants were followed for 6-months from the Massachusetts Department of Public Health. All
post-EI entry, which extends previous research suggest- authors also wish to acknowledge the Early Intervention
ing that the NBO is associated with improved parental Program directors who participated in this project: April
perceptions of their ability to read their baby’s cues and Haefner, Anne Marsh, Kelly Petravicz, Martha Levine, and
respond contingently (McManus & Nugent, 2014) as well Dawn Gutro. Finally, we are grateful to the Early Interven-
as improved EI provider confidence in working with fam- tion providers and parents who participated in this project.
ilies of high-risk newborns (McManus & Nugent, 2011). The authors acknowledge their affiliation with the
In the current pilot study, we showed that an EI–NBO Brazelton Institute (BI), Department of Newborn
model of care has a great deal of promise to be sustain- Medicine, at Children’s Hospital Boston. Researchers
able and to transform and improve how EI care is deliv- at the BI (including the second and senior authors) devel-
ered to families of high-risk infants while adding to the oped the intervention under study and the first, second,
evidence-based that infant mental health interventions and senior authors provided training and certification to
delivered in the newborn period has positive neurodevel- clinicians on the intervention tool under study.
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