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Mothers Avoiding Depression Through Empowerment Intervention Trial (MADE IT)

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral education intervention
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual

Behavioral education

Arm Description

Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail.

Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Breastfeeding continuation rate and Physical functioning

Full Information

First Posted
March 8, 2011
Last Updated
March 9, 2011
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01312883
Brief Title
Mothers Avoiding Depression Through Empowerment Intervention Trial
Acronym
MADE IT
Official Title
Center for Achieving and Sustaining Improved Health in Harlem: Patient Education to Reduce Postpartum Depressive Symptoms Among Minority Women
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail.
Arm Title
Behavioral education
Arm Type
Experimental
Arm Description
Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral education intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Breastfeeding continuation rate and Physical functioning
Time Frame
Measured at baseline and after 3 weeks, 3 months, and 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Howell, MD, MPP
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27227751
Citation
Bodnar-Deren S, Klipstein K, Fersh M, Shemesh E, Howell EA. Suicidal Ideation During the Postpartum Period. J Womens Health (Larchmt). 2016 Dec;25(12):1219-1224. doi: 10.1089/jwh.2015.5346. Epub 2016 May 26.
Results Reference
derived
PubMed Identifier
25374288
Citation
Balbierz A, Bodnar-Deren S, Wang JJ, Howell EA. Maternal depressive symptoms and parenting practices 3-months postpartum. Matern Child Health J. 2015 Jun;19(6):1212-9. doi: 10.1007/s10995-014-1625-6.
Results Reference
derived
PubMed Identifier
24262719
Citation
Howell EA, Bodnar-Deren S, Balbierz A, Parides M, Bickell N. An intervention to extend breastfeeding among black and Latina mothers after delivery. Am J Obstet Gynecol. 2014 Mar;210(3):239.e1-5. doi: 10.1016/j.ajog.2013.11.028. Epub 2013 Nov 18.
Results Reference
derived
PubMed Identifier
22581378
Citation
Negron R, Martin A, Almog M, Balbierz A, Howell EA. Social support during the postpartum period: mothers' views on needs, expectations, and mobilization of support. Matern Child Health J. 2013 May;17(4):616-23. doi: 10.1007/s10995-012-1037-4.
Results Reference
derived
PubMed Identifier
22488220
Citation
Howell EA, Balbierz A, Wang J, Parides M, Zlotnick C, Leventhal H. Reducing postpartum depressive symptoms among black and Latina mothers: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):942-9. doi: 10.1097/AOG.0b013e318250ba48.
Results Reference
derived

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Mothers Avoiding Depression Through Empowerment Intervention Trial

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