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Clinical Trials/NCT00053651
NCT00053651
Completed
Phase 1

Depression Intervention for Poor Pregnant Women

Butler Hospital1 site in 1 country250 target enrollmentSeptember 2001

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Depression, Postpartum
Sponsor
Butler Hospital
Enrollment
250
Locations
1
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2001
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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