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

This study has been completed.
Sponsor:
Collaborator:
Tufts Medical Center
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01214967
First received: September 27, 2010
Last updated: October 5, 2010
Last verified: October 2010
  Purpose

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 Intervention
Maternal Depression
Behavioral: Problem Solving Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Empowering Low Income Mothers With Preterm Infants: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Maternal Depressive Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health Care Supervision Schedule for Children [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Immunization Schedule for Children [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Problem Solving Education, a psycho-educational intervention
Behavioral: Problem Solving Education
psycho-educational intervention
No Intervention: 2
Usual care
Behavioral: Problem Solving Education
psycho-educational intervention

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214967

Locations
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
  More Information

No publications provided

Responsible Party: Michael Silverstein, MD, MPH, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01214967     History of Changes
Other Study ID Numbers: Hood-R03HD058075
Study First Received: September 27, 2010
Last Updated: October 5, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014