Interventions for Depressed Low Income Mothers and Their Infants

April 29, 2013 updated by: Sheree Toth, University of Rochester

Prevention for Infants of Low-Income Depressed Mothers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14608
        • Mount Hope Family Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interpersonal Psychotherapy
Participants will receive interpersonal psychotherapy for depression.
Behavioral: Maternal interpersonal psychotherapy (IP)
Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.
Experimental: Interpersonal psychotherapy/child-parent psychotherapy
Participants will receive interpersonal psychotherapy for depression plus 1 year of in-home, child-parent psychotherapy.
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.
Active Comparator: Enhanced community standard
Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maternal depression
Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age
Measured when the child is 12, 16, 24, 36, and 48 months of age
Child development
Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age
Measured when the child is 12, 16, 24, 36, and 48 months of age
Infant-parent attachment
Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age
Measured when the child is 12, 16, 24, 36, and 48 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Sheree Toth, PhD, Mount Hope Family Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 15, 2005

First Submitted That Met QC Criteria

March 15, 2005

First Posted (Estimate)

March 16, 2005

Study Record Updates

Last Update Posted (Estimate)

April 30, 2013

Last Update Submitted That Met QC Criteria

April 29, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH067792 (U.S. NIH Grant/Contract)
  • DSIR 84-CTP (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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