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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00074789 |
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 |
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
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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.
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2: Active Comparator
Participants will receive attention control/usual care for 26 weeks
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Behavioral: Attention control/usual care
Participants will receive the usual care for depression.
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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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
P.E.A.C.E, Inc. Early Head Start | Recruiting |
Syracuse, New York, United States, 13203 | |
Contact: Regina Canuso, MSN 315-470-3370 ext 318 rcanuso@peace-caa.org | |
Contact: Coleen Meehan 315-470-3300 cmeehan@peace-caa.org | |
Sub-Investigator: Regina Canuso, RN, MSN | |
United States, North Carolina | |
Chapel Hill Training Outreach Project, Inc. Early Head Start | Recruiting |
Chapel Hill, North Carolina, United States, 27514 | |
Contact: Angela Wilcox 919-490-5577 ext 242 awilcox@intrex.net | |
Contact: Ennis Baker 919-490-5577 edellea@intrex.net | |
Asheville City Schools Preschool-Early Head Start Program | Recruiting |
Asheville, North Carolina, United States, 28806 | |
Contact: Edel Seay 828-255-5423 edel.seay@asheville.k12.nc.us | |
Contact: Malvary Gamble 828-255-5423 malvary.gamble@asheville.k12nc.us | |
W.A.G.E.S., Inc. Early Head Start Program | Recruiting |
Goldsboro, North Carolina, United States, 27534-2570 | |
Contact: Patricia Colon 919-734-1178 | |
Contact: Bryan Sutton 919-734-1178 | |
University of North Carolina, Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-0001 | |
Contact: Virginia Lewis 919-843-2386 vslewis@email.unc.edu | |
Contact: Hjordis Blanchard 919-966-4277 hjordis@email.unc.edu | |
Principal Investigator: Linda S. Beeber, PhD | |
United Child Development Services, Inc. Early Head Start | Recruiting |
Greensboro, North Carolina, United States, 27406 | |
Contact: Glenda Welch 336-378-3300 glenda@ucds.net |
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: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00074789 |
Health Authority: | United States: Federal Government |
Early Head Start Program |
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |