Interventions for Depressed Low Income Mothers and Their Infants - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00105573

Purpose

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.

Condition	Intervention
Depression	Behavioral: Maternal interpersonal psychotherapy (IP) Behavioral: Infant-parent psychotherapy Behavioral: Informational meetings plus treatment as usual

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention for Infants of Low-Income Depressed Mothers

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Maternal depression [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ]
Child development [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ]
Infant-parent attachment [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental Participants will receive interpersonal psychotherapy for depression plus 1 year of in-home, infant-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.
3: 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 Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.

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, 36, and 48 months of age. Evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures.

Eligibility

Ages Eligible for Study:	18 Years to 44 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105573

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Dante Cicchetti, PhD

Mount Hope Family Center

More Information

No publications provided

Responsible Party:	Mount Hope Family Center ( Dante Cicchetti, PhD )
Study ID Numbers:	R01 MH67792, DSIR 84-CTP
Study First Received:	March 15, 2005
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00105573 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Mother-Child Relations
Infant
Child Development
Poverty

Study placed in the following topic categories:

Depression
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 07, 2009