Interventions for Depressed Low Income Mothers and Their Infants
Prevention for Infants of Low-Income Depressed Mothers
2 other identifiers
interventional
218
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jan 2004
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 15, 2005
CompletedFirst Posted
Study publicly available on registry
March 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedApril 30, 2013
April 1, 2013
6.3 years
March 15, 2005
April 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maternal depression
Measured when the child is 12, 16, 24, 36, and 48 months of age
Child development
Measured when the child is 12, 16, 24, 36, and 48 months of age
Infant-parent attachment
Measured when the child is 12, 16, 24, 36, and 48 months of age
Study Arms (3)
Interpersonal Psychotherapy
EXPERIMENTALParticipants will receive interpersonal psychotherapy for depression.
Interpersonal psychotherapy/child-parent psychotherapy
EXPERIMENTALParticipants will receive interpersonal psychotherapy for depression plus 1 year of in-home, child-parent psychotherapy.
Enhanced community standard
ACTIVE COMPARATORParticipants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
Interventions
Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.
Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Current substance abuse
- Severe mental or physical limitations that would interfere with the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Hope Family Center
Rochester, New York, 14608, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheree Toth, PhD
Mount Hope Family Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Director, Mt. Hope Family Center, and Associate Professor
Study Record Dates
First Submitted
March 15, 2005
First Posted
March 16, 2005
Study Start
January 1, 2004
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
April 30, 2013
Record last verified: 2013-04