NCT00105573

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

6.3 years

First QC Date

March 15, 2005

Last Update Submit

April 29, 2013

Conditions

Keywords

Mother-Child RelationsInfantChild DevelopmentPoverty

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

EXPERIMENTAL

Participants will receive interpersonal psychotherapy for depression.

Behavioral: Maternal interpersonal psychotherapy (IP)

Interpersonal psychotherapy/child-parent psychotherapy

EXPERIMENTAL

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

Enhanced community standard

ACTIVE COMPARATOR

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

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

Interpersonal PsychotherapyInterpersonal psychotherapy/child-parent psychotherapy

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

Interpersonal psychotherapy/child-parent psychotherapy

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

Enhanced community standard

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Sheree Toth, PhD

    Mount Hope Family Center

    PRINCIPAL INVESTIGATOR

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

Locations