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| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 4, 2003 |
| Last Updated Date | February 12, 2008 |
| Start Date ICMJE | September 2001 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00053651 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Prevention of Postpartum Depression in Low-Income Women |
| Official Title ICMJE | Depression Intervention for Poor Pregnant Women |
| Brief Summary | 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. |
| Detailed Description | 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 Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE | Depression, Postpartum |
| Intervention ICMJE | Behavioral: Survival Skills for Moms with New Babies |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 250 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion criteria:
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| Gender | Female |
| Ages | 18 Years to 45 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00053651 |
| Responsible Party | |
| Study ID Numbers ICMJE | R21 MH61555, DSIR AT-AS |
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Verification Date | February 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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