Postpartum DepressionBabyAMORNCT03836430
The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants
A study testing Newborn Behavioral Observation-Family Wellness (NBO-FW) in people with Postpartum Depression and Preterm Infant, run by Brigham and Women's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postpartum Depression, Preterm Infant, Infant Development
- What is being tested?
- Newborn Behavioral Observation-Family Wellness (NBO-FW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 5 May 2022
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- First time mothers of singleton newborns born between 32 and 37 weeks of gestation
- Mother fluent in either English or Spanish
Who cannot join
- Maternal history of major psychosis or suicidality
- Mother currently addicted to drugs or alcohol or being treated for drug addiction
- Health condition limiting mother's ability to care for her infant
- Primary diagnosis in infant is unrelated to prematurity
- Infant not in legal and physical custody of the mother
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed 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.
- Conditions
- Postpartum Depression, Preterm Infant, Infant Development
- Being tested
- Newborn Behavioral Observation-Family Wellness (NBO-FW)
- Keywords
- newborn behavioral observation, late preterm, postpartum depression
- Medical subject headings
- Depression, Postpartum, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newborn Behavioral Observation-Family Wellness (NBO-FW)Behavioural
The intervention has been described in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Newborn Behavioral Observation | Experimental | The Newborn Behavioral Observation-Family Wellness (NBO-FW) intervention is the experimental arm of this RCT. It consists of 3 NBOs - 2 during the birth hospitalization and the third at 6 weeks post-discharge as well as a journal with prompts for mothers to reflect on their infant's behavior and their own transition to motherhood. NBOs are clinical relationship-building tools used by trained clinicians/therapists to help parents understand their babies' unique language. Receives: Behavioral: Newborn Behavioral Observation-Family Wellness (NBO-FW) |
| Usual care | No intervention | This arm is the usual care arm. Of note, both arms receive 2 parenting books, one at hospital discharge and one at 6 weeks post-discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal postpartum depression
Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scale is 0 - 36, where higher scores indicate higher levels of depressive symptoms.
Measured: The CESD-R will be administered at enrollment when the baby is approximately 2 days old
Maternal postpartum depression
Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scale is 0 - 36, where higher scores indicate higher levels of depressive symptoms.
Measured: The CESD-R will be administered at 6 weeks
Maternal postpartum depression
Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scale is 0 - 36, where higher scores indicate higher levels of depressive symptoms.
Measured: The CESD-R will be administered at 4 months
Maternal parenting stress
Parenting Stress Index-Short Form 4th Edition (PSI-SF). We will look at the Parental Distress subscale, which is interpreted based on percentile scores. Higher percentile scores indicate higher parental distress.
Measured: The PSI-SF will be administered at enrollment when the baby is approximately 2 days old
Maternal parenting stress
Parenting Stress Index-Short Form 4th Edition (PSI-SF). We will look at the Parental Distress subscale, which is interpreted based on percentile scores. Higher percentile scores indicate higher parental distress.
Measured: The PSI-SF will be administered at 6 weeks
Maternal parenting stress
Parenting Stress Index-Short Form 4th Edition (PSI-SF)
Measured: The PSI-SF will be administered at 4 months
Parenting confidence
The Karitane Parenting Confidence Scale (KPCS). The scale ranges from 0-45, with higher scores indicating higher confidence in parenting skills and abilities.
Measured: The KPCS will be administered at 6 weeks
Parenting confidence
The Karitane Parenting Confidence Scale (KPCS). The scale ranges from 0-45, with higher scores indicating higher confidence in parenting skills and abilities.
Measured: The KPCS will be administered at 4 months
Positive Parenting Quality
Welch Emotional Connection Screen (WECS)
Measured: The WECS will be administered at 4 months
Secondary outcomes (5)
Safe sleep practices
Maternal report on questionnaire that child is put to sleep on their back, with no blankets, pillows, or other obstructions in the sleeping area.
Measured: Infant care practices will be assessed at 6 weeks.
Safe sleep practices
Maternal report on questionnaire that child is put to sleep on their back, with no blankets, pillows, or other obstructions in the sleeping area.
Measured: Infant care practices will be assessed at 4 months
Breastfeeding
Maternal report on questionnaire of feeding methods, including exclusive breastfeeding, formula supplement and short-term breastfeeding.
Measured: Infant care practices will be assessed at 6 weeks.
Breastfeeding
Maternal report on questionnaire of feeding methods, including exclusive breastfeeding, formula supplement and any changes to feeding practices across first six weeks.
Measured: Infant care practices will be assessed at 4 months.
Participation in well child visits
Maternal report on questionnaire of feeding methods, including exclusive breastfeeding, formula supplement and any changes to feeding practices across first 4 months.
Measured: Attendance at well child visits will be assessed at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Aug 2019
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel assignment involving two groups of participants. Group A received the intervention of Newborn Behavior Observation (NBO) sessions and Group B did not.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Child Trends
- Responsible party
- Principal investigator, Lise Carolyn Johnson, Brigham and Women's Hospital
- Investigators
- Lise C Johnson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836430
- Sponsor's protocol ID
- 2018P001771
- Acronym
- BabyAMOR
- Status last verified
- Aug 2022
- First submitted
- 5 Feb 2019
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants
- ClinicalTrials.gov ID
- NCT03836430
- Acronym / sponsor ID
- BabyAMOR / 2018P001771
- Conditions
- Postpartum Depression, Preterm Infant, Infant Development
- Keywords
- newborn behavioral observation, late preterm, postpartum depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Child Trends
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 11 Feb 2019 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel assignment involving two groups of participants. Group A received the intervention of Newborn Behavior Observation (NBO) sessions and Group B did not.
| Arm | Type | Receives |
|---|---|---|
| Newborn Behavioral Observation | Experimental | Behavioral: Newborn Behavioral Observation-Family Wellness (NBO-FW)The Newborn Behavioral Observation-Family Wellness (NBO-FW) intervention is the experimental arm of this RCT. It consists of 3 NBOs - 2 during the birth hospitalization and the third at 6 weeks post-discharge as well as a journal with prompts for mothers to reflect on their infant's behavior and their own transition to motherhood. NBOs are clinical relationship-building tools used by trained clinicians/therapists to help parents understand their babies' unique language. |
| Usual care | No intervention | –This arm is the usual care arm. Of note, both arms receive 2 parenting books, one at hospital discharge and one at 6 weeks post-discharge. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- First time mothers of singleton newborns born between 32 and 37 weeks of gestation
- Mother fluent in either English or Spanish
Key exclusion criteria (5 listed)
- Maternal history of major psychosis or suicidality
- Mother currently addicted to drugs or alcohol or being treated for drug addiction
- Health condition limiting mother's ability to care for her infant
- Primary diagnosis in infant is unrelated to prematurity
- Infant not in legal and physical custody of the mother
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 |
|---|---|---|
| Newborn Behavioral Observation-Family Wellness (NBO-FW)The intervention has been described in the arm description. | Behavioural | Newborn Behavioral Observation |
Primary outcome
Maternal postpartum depression
Time frame: The CESD-R will be administered at enrollment when the baby is approximately 2 days old
Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scale is 0 - 36, where higher scores indicate higher levels of depressive symptoms.
Maternal postpartum depression
Time frame: The CESD-R will be administered at 6 weeks
Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scale is 0 - 36, where higher scores indicate higher levels of depressive symptoms.
Maternal postpartum depression
Time frame: The CESD-R will be administered at 4 months
Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scale is 0 - 36, where higher scores indicate higher levels of depressive symptoms.
Maternal parenting stress
Time frame: The PSI-SF will be administered at enrollment when the baby is approximately 2 days old
Parenting Stress Index-Short Form 4th Edition (PSI-SF). We will look at the Parental Distress subscale, which is interpreted based on percentile scores. Higher percentile scores indicate higher parental distress.
Maternal parenting stress
Time frame: The PSI-SF will be administered at 6 weeks
Parenting Stress Index-Short Form 4th Edition (PSI-SF). We will look at the Parental Distress subscale, which is interpreted based on percentile scores. Higher percentile scores indicate higher parental distress.
Maternal parenting stress
Time frame: The PSI-SF will be administered at 4 months
Parenting Stress Index-Short Form 4th Edition (PSI-SF)
Parenting confidence
Time frame: The KPCS will be administered at 6 weeks
The Karitane Parenting Confidence Scale (KPCS). The scale ranges from 0-45, with higher scores indicating higher confidence in parenting skills and abilities.
Parenting confidence
Time frame: The KPCS will be administered at 4 months
The Karitane Parenting Confidence Scale (KPCS). The scale ranges from 0-45, with higher scores indicating higher confidence in parenting skills and abilities.
Positive Parenting Quality
Time frame: The WECS will be administered at 4 months
Welch Emotional Connection Screen (WECS)
5 secondary outcomes
Safe sleep practices
Time frame: Infant care practices will be assessed at 6 weeks.
Safe sleep practices
Time frame: Infant care practices will be assessed at 4 months
Breastfeeding
Time frame: Infant care practices will be assessed at 6 weeks.
Breastfeeding
Time frame: Infant care practices will be assessed at 4 months.
Participation in well child visits
Time frame: Attendance at well child visits will be assessed at 4 months
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 17 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Lise C Johnson, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newborn Behavioral Observation-Family Wellness (NBO-FW) in people with Postpartum Depression and Preterm Infant, run by Brigham and Women's Hospital at 1 site in United States.
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 2 inclusion and 5 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 17 Aug 2022. 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 United States. 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 postpartum depression (time frame: The CESD-R will be administered at enrollment when the baby is approximately 2 days old). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2022.