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| Tracking Information | |||||
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| First Received Date ICMJE | February 14, 2007 | ||||
| Last Updated Date | March 10, 2009 | ||||
| Start Date ICMJE | February 2007 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Postpartum depression diagnosis [ Time Frame: Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Postpartum depression | ||||
| Change History | Complete list of historical versions of study NCT00436150 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Degree of depressive symptoms | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers | ||||
| Official Title ICMJE | Preventing Postpartum Depression in Adolescent Mothers | ||||
| Brief Summary | This study will aim to prevent postpartum depression in pregnant teenagers through an interpersonal therapy-based program. |
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| Detailed Description | Postpartum depression is believed to be one of the most common complications after pregnancy. This type of depression often occurs within the first year after the baby is born and is most likely caused by dramatic changes in hormone levels after pregnancy. Pregnant teenagers are even more at risk for experiencing complications throughout pregnancy and parenting difficulties after delivery. Minimal research has been done on preventive ways to reduce postpartum depression in teenagers. Therefore, this study will evaluate the effectiveness of an interpersonal therapy-based program at preventing postpartum depression in financially disadvantaged pregnant teenagers. Participants will first undergo a 15-minute interview about their background and emotions. Participants will undergo a second interview and then be randomly assigned to receive either interpersonal therapy-based treatment or standard care. Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. Participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks. Homework may be assigned to review topics discussed, and all participants will receive the book Baby Basics. Following treatment, participants will meet with researchers again when they are 34 to 36 weeks pregnant; in the hospital after the baby is born; and 6, 12, and 24 weeks after the baby is born. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Depression | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | September 2009 | ||||
| Estimated Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 12 Years to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00436150 | ||||
| Responsible Party | Maureen Phipps, MD, MPH, Women & Infants Hospital | ||||
| Study ID Numbers ICMJE | R34 MH077588, DSIR 84-CTP | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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