Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)
NCT ID: NCT00951717
Last Updated: 2011-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
590 participants
INTERVENTIONAL
2009-07-31
2010-10-31
Brief Summary
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Detailed Description
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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 phone survey with a research assistant about their health, mood, and basic demographic information.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
No interventions assigned to this group
Behavioral education
Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 White or minority other than Black or Hispanic; Black and Hispanic women will be referred to a parallel study with the same protocol at Mount Sinai Hospital
* Speaks English
* Has a working telephone
18 Years
FEMALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Howell, MD, MPP
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Mount Sinai Hospital
New York, New York, United States
Countries
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References
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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.
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.
Howell EA, Bodnar-Deren S, Balbierz A, Loudon H, Mora PA, Zlotnick C, Wang J, Leventhal H. An intervention to reduce postpartum depressive symptoms: a randomized controlled trial. Arch Womens Ment Health. 2014 Feb;17(1):57-63. doi: 10.1007/s00737-013-0381-8. Epub 2013 Sep 10.
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.
Other Identifiers
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DSIR 83-ATP
Identifier Type: -
Identifier Source: secondary_id
05-1062
Identifier Type: -
Identifier Source: org_study_id