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Prevention of Postpartum Depression in Low-Income Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00053651
First Posted: February 5, 2003
Last Update Posted: August 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Butler Hospital
  Purpose
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.

Condition Intervention Phase
Depression, Postpartum Behavioral: Survival Skills for Moms with New Babies Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Depression Intervention for Poor Pregnant Women

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Estimated Enrollment: 250
Study Start Date: September 2001
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Receive public assistance
  • At risk for postpartum depression
  • Pregnant women between 23-32 weeks gestation
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
  More Information

ClinicalTrials.gov Identifier: NCT00053651     History of Changes
Other Study ID Numbers: R21MH061555 ( U.S. NIH Grant/Contract )
DSIR AT-AS
First Submitted: February 4, 2003
First Posted: February 5, 2003
Last Update Posted: August 22, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications