|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |
| Brief Title † | Reducing Symptoms of Depression in Low-Income Mothers |
| Official Title † | 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 † | Interventional |
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Primary Outcome Measure † | Level of depressive symptoms [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ] |
| Secondary Outcome Measure † | Mother child interactions [ Time Frame: Measured at Week 26 ] [ Designated as safety issue: Yes ] |
| Condition † | Depression |
| Intervention † | Behavioral: Modified Interpersonal Therapy Behavioral: Attention control/usual care |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Recruiting |
| Enrollment † | 226 |
| Start Date † | June 2003 |
| Completion Date | April 2009 |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Female |
| Ages | 15 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00074789 |
| Organization ID | R01 MH65524 |
| Secondary IDs †† | DSIR 83-ATAS, HILDA |
| Study Sponsor † | National Institute of Mental Health (NIMH) |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | National Institute of Mental Health (NIMH) |
| Verification Date | February 2008 |
| First Received Date † | December 19, 2003 |
| Last Updated Date | February 12, 2008 |