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Interventions for Depressed Low Income Mothers and Their Infants

This study is ongoing, but not recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Interventions for Depressed Low Income Mothers and Their Infants
Official Title  Prevention for Infants of Low-Income Depressed Mothers
Brief Summary

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.

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, 36, and 48 months of age. Evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Maternal depression [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ]
Child development [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ]
Infant-parent attachment [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Depression
Intervention  Behavioral: Maternal interpersonal psychotherapy (IP)
Behavioral: Infant-parent psychotherapy
Behavioral: Informational meetings plus treatment as usual
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  260
Start Date  January 2004
Completion Date December 2009
Eligibility 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
Gender Female
Ages 18 Years to 44 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00105573
Organization ID R01 MH67792
Secondary IDs †† DSIR 84-CTP
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Dante Cicchetti, PhD     Mount Hope Family Center    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date May 2008
First Received Date  March 15, 2005
Last Updated Date May 13, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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