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

NCT ID: NCT01214967

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-06-30

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.

Conditions

Maternal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

1

Problem Solving Education, a psycho-educational intervention

Group Type: EXPERIMENTAL

Problem Solving Education

Intervention Type: BEHAVIORAL

psycho-educational intervention

2

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Problem Solving Education

psycho-educational intervention

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Silverstein

BMC Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston Medical Center

Boston, Massachusetts, United States

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

Hood-R03HD058075

Identifier Type: -

Identifier Source: org_study_id