The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants
BabyAMOR
1 other identifier
interventional
208
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2022
CompletedAugust 17, 2022
August 1, 2022
2.8 years
February 5, 2019
August 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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.
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.
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.
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.
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.
The PSI-SF will be administered at 6 weeks
Maternal parenting stress
Parenting Stress Index-Short Form 4th Edition (PSI-SF)
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.
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.
The KPCS will be administered at 4 months
Positive Parenting Quality
Welch Emotional Connection Screen (WECS)
The WECS will be administered at 4 months
Secondary Outcomes (5)
Safe sleep practices
Infant care practices will be assessed at 6 weeks.
Safe sleep practices
Infant care practices will be assessed at 4 months
Breastfeeding
Infant care practices will be assessed at 6 weeks.
Breastfeeding
Infant care practices will be assessed at 4 months.
Participation in well child visits
Attendance at well child visits will be assessed at 4 months
Study Arms (2)
Newborn Behavioral Observation
EXPERIMENTALThe 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 INTERVENTIONThis 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.
Interventions
The intervention has been described in the arm description.
Eligibility Criteria
You may qualify if:
- First time mothers of singleton newborns born between 32 and 37 weeks of gestation
- Mother fluent in either English or Spanish
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Child Trendscollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lise C Johnson, MD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatrician, Department of Pediatric Newborn Medicine
Study Record Dates
First Submitted
February 5, 2019
First Posted
February 11, 2019
Study Start
August 1, 2019
Primary Completion
May 5, 2022
Study Completion
May 5, 2022
Last Updated
August 17, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share