|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Interventions for Depressed Low Income Mothers and Their Infants | ||||
| Official Title † | Prevention for Infants of Low-Income Depressed Mothers | ||||
| Brief Summary | This study will compare three interventions for depressed, low income mothers and determine which is most effective in treating maternal depression and in fostering development in infants. |
||||
| Detailed Description | Poorly educated, low income mothers are at high risk for becoming depressed. The effects of living in poverty and being reared by a depressed parent can be detrimental to an infant's development. Effective interventions to reduce maternal depression and strengthen the mother-infant relationships are needed. Participants will be randomly assigned to one of three groups. Group 1 mothers will receive 16 weekly sessions of interpersonal psychotherapy (IP) designed to directly treat maternal depression. Group 1 participants will have monthly follow-up visits for 1 year. Participants in Group 2 will receive 16 weekly sessions of IP followed by 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants. Group 3 mothers will be invited to attend informational meetings as well as be referred to local services available to people with depression. All mother-child pairs will be evaluated when the child is 12, 16, 24, 36, and 48 months of age. Evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures. |
||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Maternal depression [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ] Child development [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ] Infant-parent attachment [ Time Frame: Measured when the child is 12, 16, 24, 36, and 48 months of age ] [ Designated as safety issue: No ] |
||||
| Secondary Outcome Measure † | |||||
| Condition † | Depression | ||||
| Intervention † | Behavioral: Maternal interpersonal psychotherapy (IP) Behavioral: Infant-parent psychotherapy Behavioral: Informational meetings plus treatment as usual |
||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 260 | ||||
| Start Date † | January 2004 | ||||
| Completion Date | December 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria for Mothers:
Exclusion Criteria for Mothers:
|
||||
| Gender | Female | ||||
| Ages | 18 Years to 44 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00105573 | ||||
| Organization ID | R01 MH67792 | ||||
| Secondary IDs †† | DSIR 84-CTP | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
|
||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | March 15, 2005 | ||||
| Last Updated Date | May 13, 2008 | ||||