Reducing Symptoms of Depression in Low-Income Mothers - Tabular View

Tracking Information
First Received Date ^ICMJE	December 19, 2003
Last Updated Date	March 9, 2009
Start Date ^ICMJE	June 2003
Estimated Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 12, 2008)	Level of depressive symptoms [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00074789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 12, 2008)	Mother child interactions [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Reducing Symptoms of Depression in Low-Income Mothers
Official Title ^ICMJE	Reducing Depressive Symptoms in Low-Income Mothers
Brief Summary	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.
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Depression
Intervention ^ICMJE	Behavioral: Modified Interpersonal Therapy Behavioral: Attention control/usual care
Study Arms / Comparison Groups	Experimental: Participants will receive home-based interpersonal depression treatment for 26 weeks Active Comparator: Participants will receive attention control/usual care for 26 weeks
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	226
Estimated Completion Date	April 2009
Estimated Primary Completion Date	April 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	15 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00074789
Responsible Party	Linda S. Beeber/ Professor and Principal Investigator, School of Nursing, University of North Carolina at Chapel Hill
Study ID Numbers ^ICMJE	R01 MH65524, DSIR 83-ATAS, HILDA
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP