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Prevention of Postpartum Depression in Low-Income Women

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ClinicalTrials.gov Identifier: NCT00053651
Recruitment Status : Completed
First Posted : February 5, 2003
Last Update Posted : August 22, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Butler Hospital

February 4, 2003
February 5, 2003
August 22, 2013
September 2001
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Complete list of historical versions of study NCT00053651 on ClinicalTrials.gov Archive Site
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Prevention of Postpartum Depression in Low-Income Women
Depression Intervention for Poor Pregnant Women
This study will determine whether a prevention program reduces the incidence of postpartum depression in pregnant women who receive public assistance and are at risk for postpartum depression.

The impact of major depression in the postpartum period is profound, with considerable emotional pain for the new mother as well as disturbances in infant development. Unfortunately, few preventive interventions have been developed or systematically tested to reduce the risk of postpartum depression. An area of even greater neglect is the development of such an intervention for financially disadvantaged women who are at high risk for postpartum depression and for the disturbances associated with postpartum depression. This study will develop a psychosocial intervention for financially disadvantaged pregnant women at risk for postpartum depression.

Participants are randomly assigned to receive either the "Life at Home with a New Baby" intervention or care as usual. Women who receive the intervention join a counseling group in which information about mother-baby relationships is shared. This information is reinforced with a follow-up "booster" session after the infant is born. Participants are assessed at baseline, after the booster session (for the intervention condition) or after 2 weeks postdelivery (for the care as usual condition), and at 3 months postpartum. Depression levels and social adjustment are measured at baseline and 2 weeks after delivery. Functional status is also measured. A self-report questionnaire is completed by the mothers to measure parental distress, parent/child dysfunctional behavior, and difficult child interactions. At 3 months postpartum, a brief standardized interview is used to assess the presence of a depressive disorder.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Depression, Postpartum
Behavioral: Survival Skills for Moms with New Babies
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
Same as current
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Inclusion criteria:

  • Receive public assistance
  • At risk for postpartum depression
  • Pregnant women between 23-32 weeks gestation
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00053651
R21MH061555( U.S. NIH Grant/Contract )
R21MH061555 ( U.S. NIH Grant/Contract )
DSIR AT-AS
Yes
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Butler Hospital
National Institute of Mental Health (NIMH)
Not Provided
Butler Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP