Reducing Symptoms of Depression in Low-Income Mothers - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00074789

Purpose

This study will test the effectiveness of a short-term intervention in treating depressed young mothers with young children enrolled in Early Head Start Programs.

Condition	Intervention	Phase
Depression	Behavioral: Modified Interpersonal Therapy Behavioral: Attention control/usual care	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Reducing Depressive Symptoms in Low-Income Mothers

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

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

Primary Outcome Measures:

Level of depressive symptoms [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mother child interactions [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	226
Study Start Date:	June 2003
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive home-based interpersonal depression treatment for 26 weeks	Behavioral: Modified Interpersonal Therapy Psychiatric mental health nurses will meet with participants 10 times, an hour each time, over a period of 14 weeks. The nurses will continue to work with the mothers over the next 8 weeks by phone, conducting 5 fifteen minute phone sessions.
2: Active Comparator Participants will receive attention control/usual care for 26 weeks	Behavioral: Attention control/usual care Participants will receive the usual care for depression.

Detailed Description:

Limited resources, poor social support, and complex life problems contribute to the high prevalence and severity of depressive symptoms in low-income mothers. As depressive symptoms persist, they often rob young mothers of the energy they need for school, job training, and positive interaction with their children, which can negatively affect a child's language acquisition, intellectual development, and social conduct. This study will design and implement a home-based treatment to help young mothers manage their depressive symptoms, increase their social support, manage or resolve life issues, and effectively parent their infant or toddler through the use of EHS resources.

Mothers will be randomly assigned to receive either home-based interpersonal depression treatment or an attention control/usual care condition for 26 weeks. Assessments will be made at study start and Weeks 14, 22, and 26. Depression scales, interviews, and analyses of videotaped mother-child interactions will be used to assess participants. Stress, social support, and use of EHS services will be assessed.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale
Child who is 6 weeks to 30 months old
Child who is enrolled in an Early Head Start program

Exclusion Criteria:

Regular use of psychotropic medication
Regular use of psychotherapy or drug/alcohol treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074789

Locations

United States, New York
P.E.A.C.E, Inc. Early Head Start
Syracuse, New York, United States, 13203
United States, North Carolina
Chapel Hill Training Outreach Project, Inc. Early Head Start
Chapel Hill, North Carolina, United States, 27514
Asheville City Schools Preschool-Early Head Start Program
Asheville, North Carolina, United States, 28806
W.A.G.E.S., Inc. Early Head Start Program
Goldsboro, North Carolina, United States, 27534-2570
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599-0001
United Child Development Services, Inc. Early Head Start
Greensboro, North Carolina, United States, 27406

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

More Information

No publications provided

Responsible Party:	School of Nursing, University of North Carolina at Chapel Hill ( Linda S. Beeber/ Professor and Principal Investigator )
Study ID Numbers:	R01 MH65524, DSIR 83-ATAS, HILDA
Study First Received:	December 19, 2003
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00074789 History of Changes
Health Authority:	United States: Federal Government

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

Early Head Start Program

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 05, 2009