Reducing Symptoms of Depression in Low-Income Mothers
Reducing Depressive Symptoms in Low-Income Mothers
3 other identifiers
interventional
226
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 depression
Started Jun 2003
Longer than P75 for phase_2 depression
6 active sites
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
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 19, 2003
CompletedFirst Posted
Study publicly available on registry
December 22, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJune 21, 2013
June 1, 2013
5.3 years
December 19, 2003
June 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of depressive symptoms
Measured at Week 26
Secondary Outcomes (1)
Mother child interactions
Measured at Week 26
Study Arms (2)
1
EXPERIMENTALParticipants will receive home-based interpersonal depression treatment for 26 weeks
2
ACTIVE COMPARATORParticipants will receive attention control/usual care for 26 weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Regular use of psychotropic medication
- Regular use of psychotherapy or drug/alcohol treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
P.E.A.C.E, Inc. Early Head Start
Syracuse, New York, 13203, United States
Asheville City Schools Preschool-Early Head Start Program
Asheville, North Carolina, 28806, United States
Chapel Hill Training Outreach Project, Inc. Early Head Start
Chapel Hill, North Carolina, 27514, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599-0001, United States
W.A.G.E.S., Inc. Early Head Start Program
Goldsboro, North Carolina, 27534-2570, United States
United Child Development Services, Inc. Early Head Start
Greensboro, North Carolina, 27406, United States
Related Publications (1)
Salomon RE, Muscatell KA, Crandell J, Anderson RA, Beeber LS. A Preliminary Investigation of Psychoneurological Symptoms in Low-Income Mothers. Nurs Res. 2021 Set/Oct 01;70(5):325-333. doi: 10.1097/NNR.0000000000000518.
PMID: 33935214DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 19, 2003
First Posted
December 22, 2003
Study Start
June 1, 2003
Primary Completion
September 1, 2008
Study Completion
January 1, 2009
Last Updated
June 21, 2013
Record last verified: 2013-06