The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants
Public ClinicalTrials.gov record NCT03836430. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03836430
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 208 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2019
- Primary completion
- May 4, 2022
- Completion
- May 4, 2022
- Last update posted
- Aug 16, 2022
2019 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03836430, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 16, 2022 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03836430 live on ClinicalTrials.gov.