Reducing Symptoms of Depression in Low-Income Mothers

June 20, 2013 updated by: Linda Beeber, University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13203
        • P.E.A.C.E, Inc. Early Head Start
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Asheville City Schools Preschool-Early Head Start Program
      • Chapel Hill, North Carolina, United States, 27514
        • Chapel Hill Training Outreach Project, Inc. Early Head Start
      • Chapel Hill, North Carolina, United States, 27599-0001
        • University of North Carolina, Chapel Hill
      • Goldsboro, North Carolina, United States, 27534-2570
        • W.A.G.E.S., Inc. Early Head Start Program
      • Greensboro, North Carolina, United States, 27406
        • United Child Development Services, Inc. Early Head Start

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of depressive symptoms
Time Frame: Measured at Week 26
Measured at Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Mother child interactions
Time Frame: Measured at Week 26
Measured at Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 19, 2003

First Submitted That Met QC Criteria

December 19, 2003

First Posted (Estimate)

December 22, 2003

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH065524 (U.S. NIH Grant/Contract)
  • DSIR 83-ATAS (NIMH Program Class Code)
  • HILDA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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