Reducing Symptoms of Depression in Low-Income Mothers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Linda Beeber, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00074789
First received: December 19, 2003
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Depression
Behavioral: Modified Interpersonal Therapy
Behavioral: Attention control/usual care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Depressive Symptoms in Low-Income Mothers

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Level of depressive symptoms [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mother child interactions [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ]

Enrollment: 226
Study Start Date: June 2003
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074789

Locations
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
  More Information

No publications provided

Responsible Party: Linda Beeber, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00074789     History of Changes
Other Study ID Numbers: R01 MH65524, R01MH065524, DSIR 83-ATAS, HILDA
Study First Received: December 19, 2003
Last Updated: June 20, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Early Head Start Program

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014