Interventions for Depressed Low Income Mothers and Their Infants
Recruitment status was Active, not recruiting
Tracking Information | |||||
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First Received Date ICMJE | March 15, 2005 | ||||
Last Updated Date | May 13, 2008 | ||||
Start Date ICMJE | January 2004 | ||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00105573 on ClinicalTrials.gov Archive Site | ||||
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Descriptive Information | |||||
Brief Title ICMJE | Interventions for Depressed Low Income Mothers and Their Infants | ||||
Official Title ICMJE | 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Depression | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 260 | ||||
Estimated Completion Date | December 2009 | ||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria for Mothers:
Exclusion Criteria for Mothers:
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Gender | Female | ||||
Ages | 18 Years to 44 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00105573 | ||||
Other Study ID Numbers ICMJE | R01 MH67792, DSIR 84-CTP | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Dante Cicchetti, PhD, Mount Hope Family Center | ||||
Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
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Information Provided By | National Institute of Mental Health (NIMH) | ||||
Verification Date | May 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |