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OpenTrials
Completed

NCT Number: NCT00105573

Interventions for Depressed Low Income Mothers and Their Infants

This study will compare three interventions for depressed, low income mothers and determine which is most effective in treating maternal depression and in fostering development in infants.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Hope Family Center

Rochester, New York, 14608, United States

About this study

Poorly educated, low income mothers are at high risk for becoming depressed. The effects of living in poverty and being reared by a depressed parent can be detrimental to an infant's development. Effective interventions to reduce maternal depression and strengthen the mother-infant relationships are needed.

Participants will be randomly assigned to one of three groups. Group 1 mothers will receive 16 weekly sessions of interpersonal psychotherapy (IP) designed to directly treat maternal depression. Group 1 participants will have monthly follow-up visits for 1 year. Participants in Group 2 will receive 16 weekly sessions of IP followed by 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants. Group 3 mothers will be invited to attend informational meetings as well as be referred to local services available to people with depression.

All mother-child pairs will be evaluated when the child is 12, 16, 24, and 36 months of age. Evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for Mothers:

  • Current diagnosis of depression
  • Mother of an infant 9 to 11 months of age
  • Low income, defined as less than $25,000 for a family of two or less than $31,400 for a family of three (add approximately $7,960 for each additional family member)

Exclusion criteria

for Mothers:

  • Current substance abuse
  • Severe mental or physical limitations that would interfere with the study

Treatment and study plan

Maternal interpersonal psychotherapy (IP)

Behavioral

Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.

Infant-parent psychotherapy

Behavioral

Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.

Informational meetings plus treatment as usual

Behavioral

Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.

Primary outcomes

  1. Maternal depression

    Time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age

  2. Child development

    Time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age

  3. Infant-parent attachment

    Time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Prevention for Infants of Low-Income Depressed Mothers

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Mar 16, 2005
Registry last updated
Apr 30, 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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