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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.
ClinicalTrials.gov Identifier: NCT00074789
Recruitment Status : Completed
First Posted : December 22, 2003
Last Update Posted : June 21, 2013
Information provided by (Responsible Party):

December 19, 2003
December 22, 2003
June 21, 2013
June 2003
September 2008   (Final data collection date for primary outcome measure)
Level of depressive symptoms [ Time Frame: Measured at Week 26 ]
Not Provided
Complete list of historical versions of study NCT00074789 on ClinicalTrials.gov Archive Site
Mother child interactions [ Time Frame: Measured at Week 26 ]
Not Provided
Not Provided
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Reducing Symptoms of Depression in Low-Income Mothers
Reducing Depressive Symptoms in Low-Income Mothers
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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.
  • Behavioral: Attention control/usual care
    Participants will receive the usual care for depression.
  • Experimental: 1
    Participants will receive home-based interpersonal depression treatment for 26 weeks
    Intervention: Behavioral: Modified Interpersonal Therapy
  • Active Comparator: 2
    Participants will receive attention control/usual care for 26 weeks
    Intervention: Behavioral: Attention control/usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2009
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
15 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH065524( U.S. NIH Grant/Contract )
R01MH065524 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Linda Beeber, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Not Provided
University of North Carolina, Chapel Hill
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP