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Interventions for Depressed Low Income Mothers and Their Infants

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maternal interpersonal psychotherapy (IP)
Infant-parent psychotherapy
Informational meetings plus treatment as usual
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Mother-Child Relations, Infant, Child Development, Poverty

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Hope Family Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Interpersonal Psychotherapy

Interpersonal psychotherapy/child-parent psychotherapy

Enhanced community standard

Arm Description

Participants will receive interpersonal psychotherapy for depression.

Participants will receive interpersonal psychotherapy for depression plus 1 year of in-home, child-parent psychotherapy.

Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.

Outcomes

Primary Outcome Measures

Maternal depression
Child development
Infant-parent attachment

Secondary Outcome Measures

Full Information

First Posted
March 15, 2005
Last Updated
April 29, 2013
Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00105573
Brief Title
Interventions for Depressed Low Income Mothers and Their Infants
Official Title
Prevention for Infants of Low-Income Depressed Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Mother-Child Relations, Infant, Child Development, Poverty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpersonal Psychotherapy
Arm Type
Experimental
Arm Description
Participants will receive interpersonal psychotherapy for depression.
Arm Title
Interpersonal psychotherapy/child-parent psychotherapy
Arm Type
Experimental
Arm Description
Participants will receive interpersonal psychotherapy for depression plus 1 year of in-home, child-parent psychotherapy.
Arm Title
Enhanced community standard
Arm Type
Active Comparator
Arm Description
Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
Intervention Type
Behavioral
Intervention Name(s)
Maternal interpersonal psychotherapy (IP)
Intervention Description
Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
Intervention Type
Behavioral
Intervention Name(s)
Infant-parent psychotherapy
Intervention Description
Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.
Intervention Type
Behavioral
Intervention Name(s)
Informational meetings plus treatment as usual
Intervention Description
Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
Primary Outcome Measure Information:
Title
Maternal depression
Time Frame
Measured when the child is 12, 16, 24, 36, and 48 months of age
Title
Child development
Time Frame
Measured when the child is 12, 16, 24, 36, and 48 months of age
Title
Infant-parent attachment
Time Frame
Measured when the child is 12, 16, 24, 36, and 48 months of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheree Toth, PhD
Organizational Affiliation
Mount Hope Family Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Hope Family Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14608
Country
United States

12. IPD Sharing Statement

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Interventions for Depressed Low Income Mothers and Their Infants

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