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Improving Preterm Outcomes by Safeguarding Maternal Mental Health

NCT01892982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2018-08-28

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Problem Solving Education tailored to NICU

Sponsors & Collaborators

  • Tufts Medical Center

    collaborator OTHER

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Michael Silverstein, MD, MPH · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2018-05-25
Completion
2018-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01892982 on ClinicalTrials.gov