Working… Menu
Trial record 27 of 2725 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Reducing Symptoms of Depression in Low-Income Mothers

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. Identifier: NCT00074789
Recruitment Status : Completed
First Posted : December 22, 2003
Last Update Posted : June 21, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Linda Beeber, University of North Carolina, Chapel Hill

Brief Summary:
This study will test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in Early Head Start Programs.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Modified Interpersonal Therapy Behavioral: Attention control/usual care Phase 2

Detailed Description:

Limited resources, poor social support, and complex life problems contribute to the high prevalence and severity of depressive symptoms in low-income mothers. As depressive symptoms persist, they often rob young mothers of the energy they need for school, job training, and positive interaction with their children, which can negatively affect a child's language acquisition, intellectual development, and social conduct. This study will design and implement a home-based treatment to help young mothers manage their depressive symptoms, increase their social support, manage or resolve life issues, and effectively parent their infant or toddler through the use of EHS resources.

Mothers will be randomly assigned to receive either home-based interpersonal depression treatment or an attention control/usual care condition for 26 weeks. Assessments will be made at study start and Weeks 14, 22, and 26. Depression scales, interviews, and analyses of videotaped mother-child interactions will be used to assess participants. Stress, social support, and use of EHS services will be assessed.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Depressive Symptoms in Low-Income Mothers
Study Start Date : June 2003
Actual Primary Completion Date : September 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Participants will receive home-based interpersonal depression treatment for 26 weeks
Behavioral: Modified Interpersonal Therapy
Psychiatric mental health nurses will meet with participants 10 times, an hour each time, over a period of 14 weeks. The nurses will continue to work with the mothers over the next 8 weeks by phone, conducting 5 fifteen minute phone sessions.

Active Comparator: 2
Participants will receive attention control/usual care for 26 weeks
Behavioral: Attention control/usual care
Participants will receive the usual care for depression.

Primary Outcome Measures :
  1. Level of depressive symptoms [ Time Frame: Measured at Week 26 ]

Secondary Outcome Measures :
  1. Mother child interactions [ Time Frame: Measured at Week 26 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale
  • Child who is 6 weeks to 30 months old
  • Child who is enrolled in an Early Head Start program

Exclusion Criteria:

  • Regular use of psychotropic medication
  • Regular use of psychotherapy or drug/alcohol treatment

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 identifier (NCT number): NCT00074789

Layout table for location information
United States, New York
P.E.A.C.E, Inc. Early Head Start
Syracuse, New York, United States, 13203
United States, North Carolina
Asheville City Schools Preschool-Early Head Start Program
Asheville, North Carolina, United States, 28806
Chapel Hill Training Outreach Project, Inc. Early Head Start
Chapel Hill, North Carolina, United States, 27514
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599-0001
W.A.G.E.S., Inc. Early Head Start Program
Goldsboro, North Carolina, United States, 27534-2570
United Child Development Services, Inc. Early Head Start
Greensboro, North Carolina, United States, 27406
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)

Layout table for additonal information
Responsible Party: Linda Beeber, Professor, University of North Carolina, Chapel Hill Identifier: NCT00074789     History of Changes
Other Study ID Numbers: R01MH065524 ( U.S. NIH Grant/Contract )
R01MH065524 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2003    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Linda Beeber, University of North Carolina, Chapel Hill:
Early Head Start Program
Additional relevant MeSH terms:
Layout table for MeSH terms
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders