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The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants
NCT03836430 · View on ClinicalTrials.gov ↗
Study 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, sen
Conditions Studied
Interventions
- BEHAVIORAL Newborn Behavioral Observation-Family Wellness (NBO-FW)
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2022-05-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03836430
The ClinicalTrials.gov registry entry for NCT03836430 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 208 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 929 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Postpartum Depression appearing as the primary indexed condition, and to 1 intervention — of which Newborn Behavioral Observation-Family Wellness (NBO-FW) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03836430 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03836430 about?
NCT03836430 is a clinical study titled "The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants". 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 inter...
What is the current status of trial NCT03836430?
This trial is currently completed. It is a NA study. The enrollment target is 208 participants. The study started on 2019-08-01. Estimated completion is 2022-05-05.
What conditions does trial NCT03836430 study?
This clinical trial studies the following conditions: Postpartum Depression, Infant Development, Preterm Infant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03836430?
The interventions under investigation include: Newborn Behavioral Observation-Family Wellness (NBO-FW) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03836430?
This trial is sponsored by Brigham and Women's Hospital, which has 929 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03836430 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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