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
|Condition or disease||Intervention/treatment||Phase|
|Depression, Postpartum||Behavioral: Survival Skills for Moms with New Babies||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Depression Intervention for Poor Pregnant Women|
|Study Start Date :||September 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053651
|United States, Rhode Island|
|Women and Infants Hospital|
|Providence, Rhode Island, United States, 02903|