Mothers Avoiding Depression Through Empowerment Intervention Trial (MADE IT)

March 9, 2011 updated by: Icahn School of Medicine at Mount Sinai

Center for Achieving and Sustaining Improved Health in Harlem: Patient Education to Reduce Postpartum Depressive Symptoms Among Minority Women

Postpartum depressive symptoms are a major health problem that affects hundreds of women annually. The investgators propose to test an intervention to reduce postpartum depressive symptoms and prevent elevated levels of depressive symptoms in postpartum mothers by preparing and educating women about specific situational triggers of depressive symptoms, by bolstering personal and social resources, by enhancing self-management skills to buffer postpartum demands, and by increasing access to existing healthcare and community resources available to postpartum mothers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postpartum depression (PPD) is a disorder affecting many women after delivery of a child. Up to 50% of mothers may experience some depressive symptoms after giving birth, and up to 25% of them will develop major depressive disorder. Some situational factors that place mothers at risk of PPD may be changed or minimized, including social support, the mother's efficiency in handling situational stress, and distress from physical symptoms. Preparing mothers to identify potential situational triggers of depressive symptoms, enhancing their postpartum self-management skills , and providing them access to the proper social and healthcare resources may prevent them from developing major depression. This study will test the efficacy of a brief intervention that aims to prevent PPD by preparing mothers to deal with stressful triggers and depressive symptoms.

This study will last 6 months. Participants will be randomly assigned to receive either treatment as usual or the behavioral education intervention. The intervention will involve two parts. First, after giving birth and while still in the hospital, participants will complete an education session with a social worker and receive written materials about PPD. Then, 2 weeks after discharge from the hospital, participants will receive a call from the social worker, who will conduct a needs assessment that addresses participants' physical and emotional health. If a participant is experiencing distress, the social worker will refer her to appropriate resources and will reinforce self-management skills. All participants will receive a list of community and hospital resources by mail.

Study assessments will take place at 3 weeks, 3 months, and 6 months after study entry. At these points, participants will complete a 20-minute survey with a research assistant about their health, mood, and basic demographic information.

Study Type

Interventional

Enrollment (Actual)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient in the Maternity Unit at Mount Sinai Hospital
  • Infant has a birth weight greater than or equal to 2,500 grams
  • Infant has a 5-minute Apgar score greater than or equal to 7
  • Self-identifies as Black/African American or Hispanic/Latina; White or minority other than Black/African American or Hispanic/Latina will be referred to a parallel study with the same protocol at Mount Sinai Hospital
  • Speaks English or Spanish
  • Has a working telephone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Treatment as usual
Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail.
EXPERIMENTAL: Behavioral education
Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.
Behavioral: Behavioral education intervention
One education session with a social worker while at the hospital, provision of an educational pamphlet and summary sheet for partner, a needs assessment by the social worker 2 weeks after hospital discharge, and additional patient education and reinforcement of self-management skills, as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women.
Time Frame: Measured at baseline
Measured at baseline
The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women.
Time Frame: Measured at 3 weeks postpartum
Measured at 3 weeks postpartum
The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women.
Time Frame: Measured at 3 months postpartum
Measured at 3 months postpartum
The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women.
Time Frame: Measured at 6 months postpartum
Measured at 6 months postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
Breastfeeding continuation rate and Physical functioning
Time Frame: Measured at baseline and after 3 weeks, 3 months, and 6 months
Measured at baseline and after 3 weeks, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Elizabeth A Howell, MD, MPP, ICAHN School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (ESTIMATE)

March 11, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2011

Last Update Submitted That Met QC Criteria

March 9, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2P60MD000270-06 (NIH)
  • P60MD000270 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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