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CompletedNCT00105573Updated Apr 30, 2013

Interventions for Depressed Low Income Mothers and Their Infants

An interventional study of Maternal interpersonal psychotherapy (IP) and Infant-parent psychotherapy in Depression, sponsored by University of Rochester. Completed at 1 site in United States. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-30.

Sponsored by University of Rochester · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
218
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression

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Keywords

  • Mother-Child Relations
  • Infant
  • Child Development
  • Poverty
03

In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 218 is above the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion Criteria for Mothers:

  • Current substance abuse
  • Severe mental or physical limitations that would interfere with the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
218 participants (actual)

Study arms

  • Experimental
    Interpersonal Psychotherapy

    Participants will receive interpersonal psychotherapy for depression.

    Behavioral: Maternal interpersonal psychotherapy (IP)

  • 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) · Behavioral: Infant-parent psychotherapy

  • 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

Interventions

  • BehavioralMaternal interpersonal psychotherapy (IP)

    Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.

  • BehavioralInfant-parent psychotherapy

    Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.

  • BehavioralInformational 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.

06

What researchers measure

Primary outcomes

  1. Maternal depression

    Time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age

  2. Child development

    Time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age

  3. Infant-parent attachment

    Time frame: Measured when the child is 12, 16, 24, 36, and 48 months of age

07

Study locations

1 site
  • Mount Hope Family Center
    Rochester, New York 14608, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00105573
Lead sponsor
University of Rochester
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sheree Toth (Executive Director, Mt. Hope Family Center, and Associate Professor, University of Rochester) — Principal investigator
First posted
Mar 16, 2005
Start date
Jan 2004
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Apr 30, 2013

Study contacts

Sheree Toth, PhD
principal investigator · Mount Hope Family Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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