Interventions for Depressed Low Income Mothers and Their Infants

NCT ID: NCT00105573

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interpersonal Psychotherapy

Participants will receive interpersonal psychotherapy for depression.

Group Type EXPERIMENTAL

Maternal interpersonal psychotherapy (IP)

Intervention Type BEHAVIORAL

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

Interpersonal psychotherapy/child-parent psychotherapy

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

Group Type EXPERIMENTAL

Maternal interpersonal psychotherapy (IP)

Intervention Type BEHAVIORAL

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

Infant-parent psychotherapy

Intervention Type BEHAVIORAL

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

Enhanced community standard

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

Group Type ACTIVE_COMPARATOR

Informational meetings plus treatment as usual

Intervention Type BEHAVIORAL

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

Interventions

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Maternal interpersonal psychotherapy (IP)

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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* Current substance abuse
* Severe mental or physical limitations that would interfere with the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Sheree Toth

Executive Director, Mt. Hope Family Center, and Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheree Toth, PhD

Role: PRINCIPAL_INVESTIGATOR

Mount Hope Family Center

Locations

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Mount Hope Family Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH067792

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 84-CTP

Identifier Type: -

Identifier Source: secondary_id

R01MH067792

Identifier Type: NIH

Identifier Source: org_study_id

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