Reducing Risk After an Adverse Pregnancy Outcome



Status:Completed
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:5/5/2014
Start Date:August 2010
End Date:June 2013
Contact:Elaine L Fitzgerald, MIA
Email:elaine.fitzgerald@bmc.org
Phone:617 414 2008

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Reducing Risk After an Adverse Pregnancy Outcome: Addressing Maternal Depression During Internatal Periods

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.

Community-based programs that target vulnerable families consistently identify maternal
depression as a factor that negatively impacts maternal and child outcomes. A population in
particular need of mental health interventions are mothers of children with 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, a group with increased incidence of
depression. Children of depressed mothers are at risk for a vast range of poor physical,
cognitive, and emotional problems. Children who have existing underlying developmental
concerns due to adverse birth circumstances are especially vulnerable. Therefore,
identifying at-risk mothers and intervening to prevent the onset or re-occurrence of
depression represents an opportunity not only to help the women affected, but also to
improve developmental and behavioral outcomes for their children. Children under 3 with
conditions that impact their developmental trajectories receive services through federally
mandated Early Intervention (EI) programs; thus early intervention is an important, but
underutilized, setting for identification and intervention with at-risk mothers. While
effective preventative psychosocial treatments for depression exist, none have been
delivered and evaluated in the context of a home-based program specifically for mothers of
infants and children with developmental and other chronic health conditions.

The demographics of early intervention families suggest that mothers of enrolled children
are at risk for depressive illness. Families are poorer (1 in 4 received welfare payments in
the past year), mothers less well educated, and African-Americans are overrepresented (21%
vs. 14% of general population), reflecting known risk factors for depression. Almost half of
the infants who enter early intervention in the first year of life, the target group for the
proposed intervention, are low birth weight (LBW) and have significantly higher levels of
demographic risk factors than their normal birth weight peers. Numerous studies have
documented elevated incidence of depression among mothers of early born infants. The
youngest early intervention enrollees are also more likely to have identified disabilities
or conditions, such as cerebral palsy and requirements for assistive technologies that have
also been associated with higher rates of maternal depressive symptoms

Strong problem-solving abilities serve as important buffers against the negative impact of
life stressors; whereas limited problem solving skills have been linked to the cause and
persistence of psychological disorders. Problem solving approaches to depression prevention
and treatment are rooted in research that has demonstrated that minor life events or
problems are highly correlated with psychological distress, in general, and with depression,
specifically. Problem solving interventions that promote skill building have demonstrated
effectiveness in reducing behavioral risk, including depression, in a number of settings.
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.

The effectiveness of Problem solving education has been well documented in reducing
depressive symptoms and increasing function among patients with major depression and
possibly minor depression and dysthymia. We propose a research plan that involves delivering
Problem solving education to at risk mothers to (i) directly reduce symptom burden among
mothers with depressive symptoms, and (ii) facilitate access to further mental health
services.

Inclusion Criteria:

- Mothers of children with a child < or equal to 18 months of age

- Mothers who speaks English

- 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).

Exclusion Criteria:

- Women whose children are not currently enrolled in early intervention.

- Inability to speak English (The study will be opened to Spanish speakers once all
study staff have been hired and the materials have been translated. An amendment will
be submitted when that occurs.)

- 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.
We found this trial at
4
sites
Natick, Massachusetts 01760
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Natick, MA
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Boston, Massachusetts 02114
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Boston, MA
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Providence, Rhode Island 02905
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Providence, RI
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Quincy, MA
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