Reducing Risk After an Adverse Pregnancy Outcome

Completed · Not applicable

Conditions studied: Maternal Depression

In brief

This application to the Boston University Medical Center Institutional Review Board outlines a research plan devoted to identifying and managing maternal depression in Early Intervention (EI). The target population is women who's children are enrolled in early intervention who have experienced an adverse pregnancy outcome, defined as the birth of a child who was born prematurely, low birth weight, or with birth defects. Early intervention provides developmental services to the state's birth to three population under the Part C of the Individuals with Disabilities Act (IDEA). Our intervention strategy involves the identification of mothers whose children receive early intervention services and who, themselves, are at risk for depression. Eligible mothers will be offered a preventative intervention that involves the principles of Problem Solving Treatment (PST). Problem Solving Treatment is a brief skills-building psychotherapeutic intervention that focuses on specific daily problems, and applies to these problems a structured approach to finding and evaluating solutions. This study will be a parallel group randomized control trial (RCT) of 188 mother-child dyads. Mothers in the intervention group will receive 6 sessions of Problem Solving Treatment, which will be referred to as Problem Solving Education (PSE) in this application. The women in the control site will receive usual care. Problem Solving Education interventionists (Problem Solving Educators or PS Educators) will conduct Problem Solving Education with mothers of children who receive early intervention services through Thom Child and Family Services, Bay Cove Early Intervention program, South Shore Mental Health (Step One Early Intervention), and Meeting Street Early Intervention with an enrollment goal of 188 mothers. In addition to engaging in Problem Solving Education sessions, mothers who agree to participate in the study will meet with research staff to complete 1)baseline assessment measures at study enrollment and 2) outcome assessment measures 3 months after baseline assessment and 3) outcome assessment measures 6 months after baseline assessment.

Key facts

Study ID

NCT01182363

Run by

Boston Medical Center

People needed

188

Starts

2010-08-01

Expected to finish

2014-01-01

Last updated by the study team

2014-08-28

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Mothers of children with a child < or equal to 18 months of age
• Mothers who speaks English or Spanish
• Mothers of children who receive early intervention services for a condition related to an adverse pregnancy outcome (gestational age less than 37 weeks, birth weight less than 2500 grams, congenital, genetic or other condition expected to result in chronic health condition or developmental delay, Neonatal Intensive Care Unit admission great than 5 days, Apgar of 5 at 5 minutes).
• Mother meets depression risk criteria in 2/4 areas of risk (current depressive symptoms, risk factors for depressive illness, social risk, limited financial resources).

You may not qualify if…

• Women whose children are not currently enrolled in early intervention.
• Lack capacity to understand study procedures and provide consent
• Plan to relocate to another geographic region within 6 months
• Current psychosis
• Active suicidal ideation
• Diagnosis of schizophrenia.
• Mother actively using illicit drugs.
• Child's adverse birth outcome is not expected to result in chronic health condition or developmental delay.

Where it is running

• Bay Cove Early Intervention — Boston, Massachusetts, United States
• THOM Child and Family Services — Natick, Massachusetts, United States
• South Shore Mental Health Step One Early Intervention — Quincy, Massachusetts, United States
• Meeting Street — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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