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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00105573 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention for Infants of Low-Income Depressed Mothers |
Estimated Enrollment: | 260 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Participants will receive interpersonal psychotherapy for depression.
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Behavioral: Maternal interpersonal psychotherapy (IP)
Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
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2: Experimental
Participants will receive interpersonal psychotherapy for depression plus 1 year of in-home, infant-parent psychotherapy.
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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.
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3: Active Comparator
Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
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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.
|
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.
Ages Eligible for Study: | 18 Years to 44 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Mothers:
Exclusion Criteria for Mothers:
Responsible Party: | Mount Hope Family Center ( Dante Cicchetti, PhD ) |
Study ID Numbers: | R01 MH67792, DSIR 84-CTP |
Study First Received: | March 15, 2005 |
Last Updated: | May 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00105573 History of Changes |
Health Authority: | United States: Federal Government |
Mother-Child Relations Infant Child Development Poverty |
Depression Depressive Disorder Behavioral Symptoms |
Depression Behavioral Symptoms |