Mothers Avoiding Depression Through Empowerment Intervention Trial

NCT01312883 | Completed DMC

• 2 other identifiers: 2P60MD000270-06P60MD000270
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Measured at 6 months postpartum

Secondary Outcomes (1)

• Breastfeeding continuation rate and Physical functioning

  Measured at baseline and after 3 weeks, 3 months, and 6 months

Study Arms (2)

Treatment as usual

NO INTERVENTION

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

Behavioral education

EXPERIMENTAL

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

Behavioral: Behavioral education intervention

Interventions

Behavioral education intervention BEHAVIORAL

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

Behavioral education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (5)

• 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.

  PMID: 27227751 DERIVED

• 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.

  PMID: 25374288 DERIVED

• 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.

  PMID: 24262719 DERIVED

• 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.

  PMID: 22581378 DERIVED

• 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.

  PMID: 22488220 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Elizabeth A Howell, MD, MPP

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 11, 2011
• Study Start: September 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 11, 2011

Record last verified: 2011-03

Locations

US (1)