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Reducing Risk After an Adverse Pregnancy Outcome

Primary Purpose

Maternal Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Solve Education
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Depression focused on measuring maternal depression, prematurity, early intervention, developmental delay

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • Bay Cove Early Intervention
  • THOM Child and Family Services
  • South Shore Mental Health Step One Early Intervention
  • Meeting Street

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Problem Solving Education

Arm Description

Usual early intervention services

Outcomes

Primary Outcome Measures

Quick Inventory of Depressive Symptomology

Secondary Outcome Measures

Parent Stress Index
Social Adjustment Scale - Self-report (SAS- SR)
Perceived Stress Scale
Social Problem Solving Inventory

Full Information

First Posted
July 28, 2010
Last Updated
August 26, 2014
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01182363
Brief Title
Reducing Risk After an Adverse Pregnancy Outcome
Official Title
Reducing Risk After an Adverse Pregnancy Outcome: Addressing Maternal Depression During Internatal Periods
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression
Keywords
maternal depression, prematurity, early intervention, developmental delay

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual early intervention services
Arm Title
Problem Solving Education
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Project Solve Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomology
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Parent Stress Index
Time Frame
Baseline
Title
Social Adjustment Scale - Self-report (SAS- SR)
Time Frame
Baseline
Title
Perceived Stress Scale
Time Frame
Baseline
Title
Social Problem Solving Inventory
Time Frame
Baseline

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Feinberg, ScD CPNP
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bay Cove Early Intervention
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
THOM Child and Family Services
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Facility Name
South Shore Mental Health Step One Early Intervention
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Meeting Street
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

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