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Completed

NCT Number: NCT00074789

Reducing Symptoms of Depression 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.

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

P.E.A.C.E, Inc. Early Head Start, Syracuse, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Interpersonal Therapy

Behavioral

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.

Attention control/usual care

Behavioral

Participants will receive the usual care for depression.

Primary outcomes

  1. Level of depressive symptoms

    Time frame: Measured at Week 26

Secondary outcomes

  1. Mother child interactions

    Time frame: Measured at Week 26

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Reducing Depressive Symptoms in Low-Income Mothers

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Dec 22, 2003
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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