Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053651
Status:
COMPLETED
Last Update Posted:
2013-08-22
First Post:
2003-02-04
Brief Title:
Prevention of Postpartum Depression in Low-Income Women
Sponsor:
Butler Hospital
Organization:
Butler Hospital
Study Overview
Official Title:
Depression Intervention for Poor Pregnant Women
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 parentchild dysfunctional behavior and difficult child interactions At 3 months postpartum a brief standardized interview is used to assess the presence of a depressive disorder
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 parentchild 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR AT-AS | US NIH GrantContract | None | httpsreporternihgovquickSearchR21MH061555 |
| R21MH061555 | NIH | None | None |