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Interventions for Depressed Low Income Mothers and Their Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00105573
First Posted: March 16, 2005
Last Update Posted: April 30, 2013
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sheree Toth, University of Rochester
  Purpose
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.

Condition Intervention
Depression Behavioral: Maternal interpersonal psychotherapy (IP) Behavioral: Infant-parent psychotherapy Behavioral: Informational meetings plus treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention for Infants of Low-Income Depressed Mothers

Further study details as provided by Sheree Toth, University of Rochester:

Primary Outcome Measures:
  • Maternal depression [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ]
  • Child development [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ]
  • Infant-parent attachment [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ]

Enrollment: 218
Study Start Date: January 2004
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interpersonal Psychotherapy
Participants will receive interpersonal psychotherapy for depression.
Behavioral: Maternal interpersonal psychotherapy (IP)
Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
Experimental: Interpersonal psychotherapy/child-parent psychotherapy
Participants will receive interpersonal psychotherapy for depression plus 1 year of in-home, child-parent psychotherapy.
Behavioral: Maternal interpersonal psychotherapy (IP)
Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
Behavioral: Infant-parent psychotherapy
Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.
Active Comparator: Enhanced community standard
Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
Behavioral: Informational meetings plus treatment as usual
Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105573


Locations
United States, New York
Mount Hope Family Center
Rochester, New York, United States, 14608
Sponsors and Collaborators
University of Rochester
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Sheree Toth, PhD Mount Hope Family Center
  More Information

Responsible Party: Sheree Toth, Executive Director, Mt. Hope Family Center, and Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00105573     History of Changes
Other Study ID Numbers: R01MH067792 ( U.S. NIH Grant/Contract )
DSIR 84-CTP
First Submitted: March 15, 2005
First Posted: March 16, 2005
Last Update Posted: April 30, 2013
Last Verified: April 2013

Keywords provided by Sheree Toth, University of Rochester:
Mother-Child Relations
Infant
Child Development
Poverty