Reducing Risk After an Adverse Pregnancy Outcome

NCT01182363 | Completed

• 1 other identifier: H28906
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 4

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.

Conditions

Maternal Depression

Keywords

maternal depression; prematurity; early intervention; developmental delay

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomology

  Baseline

Secondary Outcomes (4)

• Parent Stress Index

  Baseline

• Social Adjustment Scale - Self-report (SAS- SR)

  Baseline

• Perceived Stress Scale

  Baseline

• Social Problem Solving Inventory

  Baseline

Study Arms (2)

Control

NO INTERVENTION

Usual early intervention services

Problem Solving Education

EXPERIMENTAL

Behavioral: Project Solve Education

Interventions

Project Solve Education BEHAVIORAL

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.

Problem Solving Education

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (4)

Bay Cove Early Intervention

Boston, Massachusetts, 02114, United States

Location

THOM Child and Family Services

Natick, Massachusetts, 01760, United States

Location

South Shore Mental Health Step One Early Intervention

Quincy, Massachusetts, 02169, United States

Location

Meeting Street

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Premature Birth; Learning Disabilities

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Emily Feinberg, ScD CPNP

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: August 16, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 28, 2014

Record last verified: 2014-08

Locations

US (4)