Improving Preterm Outcomes by Safeguarding Maternal Mental Health
2 other identifiers
interventional
325
1 country
4
Brief Summary
The investigators' goal is to optimize the developmental outcomes of preterm infants by preventing depression and improving functioning among their mothers during the critical first year of life. The investigators are conducting a randomized controlled trial of a replicable, lay-delivered intervention - the basic approach of which is to use an empirically-supported, cognitive behavioral strategy to help mothers solve their unique daily problems and address some of the predictable challenges to parenting a preterm infant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jun 2013
Longer than P75 for not_applicable depression
4 active sites
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
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 2, 2013
CompletedFirst Posted
Study publicly available on registry
July 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedAugust 28, 2018
August 1, 2018
5 years
July 2, 2013
August 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of major depressive episode and depressive symptom trajectories
To measure depression and depressive symptom trajectories, we will combine a dimensional measure (the Quick Inventory of Depressive Symptoms - QIDS) with the diagnostic Structured Clinical Interview for DSM-IV Disorders (SCID). Administering the QIDS every other month during this time frame will allow us to follow depression symptom trajectories with a repeated measure sensitive to change with treatment. Administering the SCID at 12-months will allow us to determine timing and severity of major depressive episode(s).
one year
General Functioning
General functioning will be measured by the mean total SAS-SR score, and mean scores for the family, partner, and social SAS subscales. The SAS will be administered at 6 and 12 months of follow-up.
one year
Secondary Outcomes (5)
Caregiver burden, mastery and social support
one year
Adherence to recommended NICU follow-up care
one year
Parent-child interaction
one year
Socio-emotional functioning
one year
Cognitive functioning
one year
Study Arms (2)
Problem Solving Education tailored to NICU
EXPERIMENTALNICU-PSE integrates motivational interviewing and problem solving, with ongoing monitoring and linkage to mental health services for mothers with worsening depressive symptoms over time. The intervention is provided over six sessions, including three tailored, post-discharge sessions, which address issues common to families of preterm infants: caregiver burden, complexity of medical follow-up, and social reintegration following hospitalization.
Control
NO INTERVENTIONBoth study groups receive standard NICU medical, social work, and nursing services. At each study site, attending neonatologists and pediatrics residents constitute the medical team, and all families are assigned a social worker.
Interventions
Eligibility Criteria
You may qualify if:
- Baby is 26-34 weeks gestational age
- Baby qualifies to receive Medicaid
- Mother comfortable in English or Spanish
- Singleton or twin gestation
- Baby is expected to survive
You may not qualify if:
- Mother in major depressive episode or endorses suicidality
- Mother with psychosis or otherwise cognitively limited
- Mother with known active substance use; custody of infant uncertain
- Infant is critically ill
- Triplets or higher number gestation
- Mother who is enrolled in another study receiving the same intervention that we are testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Medical Centerlead
- Tufts Medical Centercollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Brigham and Women's Hospitalcollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (4)
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related Publications (1)
Elansary M, Zuckerman B, Patts G, Antonio J, Mayes LC, Silverstein M. Posttraumatic Stress Symptoms and the Quality of Maternal-Child Interactions in Mothers of Preterm Infants. J Dev Behav Pediatr. 2022 Dec 1;43(9):e605-e613. doi: 10.1097/DBP.0000000000001122. Epub 2022 Aug 29.
PMID: 36040801DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Silverstein, MD, MPH
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2013
First Posted
July 8, 2013
Study Start
June 1, 2013
Primary Completion
May 25, 2018
Study Completion
July 31, 2018
Last Updated
August 28, 2018
Record last verified: 2018-08