Problem Solving Education and Neonatal Intensive Care Unit (NICU) Mothers (Project Solve)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01214967
Recruitment Status : Completed
First Posted : October 5, 2010
Last Update Posted : October 10, 2016
Tufts Medical Center
Information provided by (Responsible Party):
Michael Silverstein, Boston Medical Center

Brief Summary:

Premature infants are born at substantial risk for poor health and developmental outcomes, which commonly include hearing and vision problems, developmental delays, and poor school performance. Premature infants of low-income families face additional social risks known to worsen these outcomes. The Institute of Medicine recognized this important public health problem in its 2006 report, Preterm Birth, which argued for the need to improve the quality of follow-up care for preterm infants discharged from the neonatal intensive care unit (NICU). The underpinning of this proposal is that maternal depression - common among families of premature infants - interferes with adherence to follow-up services, and (both through this mechanism and directly) adversely impacts child health and development. Conversely, alleviating depressive symptoms among these women represents a promising strategy to improve adherence to NICU follow-up services and to improve the outcomes of this vulnerable population.

This project aims to mitigate the adverse effects of maternal depression in this specific high-risk population by testing a theory-based, parent-directed empowerment strategy, called Problem Solving Education (PSE). In the past, similar strategies have been proven effective for improving the mood and functioning of depressed adults, and for improving adherence to medical treatment. However, they have never been tested in the setting of a parent-child relationship or among families of premature infants.

This project involves a clinical trial of PSE among 50 low-income mothers at risk for depression, who have premature infants in two Boston NICUs: Boston Medical Center and Tufts Medical Center. The investigators aim to determine the impact of PSE on maternal depressive symptoms and functioning, and adherence to child health supervision and immunization schedules, vision screening, and early intervention evaluation for babies with suspected developmental delays.

Approximately 100,000 children are born prematurely to low-income families each year. Parent-directed PSE aims to improve outcomes for these children through the prevention and/or attenuation of maternal depressive symptoms, as well as through family activation and promotion of adherence to follow-up care. If successful, PSE could also provide the cornerstone of a more generalizable empowerment strategy for families of children with chronic medical conditions.

Condition or disease Intervention/treatment Phase
Maternal Depression Behavioral: Problem Solving Education Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Empowering Low Income Mothers With Preterm Infants: a Randomized Controlled Trial
Study Start Date : October 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Problem Solving Education, a psycho-educational intervention
Behavioral: Problem Solving Education
psycho-educational intervention
No Intervention: 2
Usual care

Primary Outcome Measures :
  1. Maternal Depressive Symptoms [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Health Care Supervision Schedule for Children [ Time Frame: 6 months ]
  2. Immunization Schedule for Children [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Baby is ≤ 33 weeks gestational age and is expected to survive.
  • Baby qualifies to receive WIC
  • Mother is comfortable in English or Spanish.

Exclusion Criteria:

  • Mother has psychosis
  • Mother endorses suicidal ideation
  • Custody of baby is uncertain
  • Mother is cognitively limited, per judgment of NICU attending physician
  • Baby is critically ill, per judgment of NICU attending physician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01214967

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Tufts Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Tufts Medical Center

Responsible Party: Michael Silverstein, BMC Attending Physician, Boston Medical Center Identifier: NCT01214967     History of Changes
Other Study ID Numbers: Hood-R03HD058075
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2010

Keywords provided by Michael Silverstein, Boston Medical Center:
risk factors for maternal depression

Additional relevant MeSH terms:
Behavioral Symptoms