Reducing Risk After an Adverse Pregnancy Outcome

Summary

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.

Conditions

• Maternal Depression

Interventions

BEHAVIORAL

Project Solve Education

Problem solving education (PSE), 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, is one such problem solving approach. Problem solving education differs from other problem solving interventions in that it can be conducted by a variety of health providers, who do not have specific training as mental health clinicians. Sessions are fairly brief (approximately 30 minutes in length) and positive, sustained effects have been achieved in 6-8 sessions. Problem solving education's success is based on premise that strong problem solving abilities promote a sense of control and self-efficacy and buffer the negative effects of life stressors.

Sponsors & Collaborators

• Boston Medical Center

  lead OTHER

Principal Investigators

• Emily Feinberg, ScD CPNP · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2014-01-31

Completion

2014-01-31

Countries

• United States

Study Locations