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| ID | Type | Description | Link |
|---|---|---|---|
| 3U18HD030445 | U.S. NIH Grant/Contract | View source | |
| 3U18HD030447 | U.S. NIH Grant/Contract | View source | |
| 5U18HD031206 | U.S. NIH Grant/Contract | View source | |
| 3U18HD031919 | U.S. NIH Grant/Contract | View source | |
| 5U18HD036104 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's National Research Institute | OTHER |
| Georgetown University | OTHER |
| George Washington University | OTHER |
| Howard University |
The purpose of this study is to determine if an integrated intervention addressing active smoking, environmental tobacco smoke exposure, depression and intimate partner violence, would improve pregnancy outcome among African American women.
This study recruited pregnant, English speaking women from the District of Columbia who were African American or Latina and had one or more of the following risk factors: active smoking, environmental tobacco smoke exposure, depression and intimate partner violence. Women were randomized to receive either an integrated intervention or usual prenatal care. Women randomized to the intervention arm received a cognitive behavioral intervention delivered during the prenatal period in four to eight sessions. Up to two postpartum booster sessions were provided. Sessions were delivered coincident with prenatal care visits. Careful attention was paid to individualizing counseling to provide an integrated approach to each participant's multiple risk factors. The outcomes of interest were primarily behavior change with regard to the risk factors and secondarily to improved birth outcomes, specifically birthweight and gestation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of risk behaviors: | ||
| Active smoking | ||
| Environmental Tobacco Smoke Exposure | ||
| Depression | ||
| Intimate Partner Violence |
| Measure | Description | Time Frame |
|---|---|---|
| birth weight | ||
| gestational age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michele Kiely, DrPH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Howard University | Washington D.C. | District of Columbia | 20059 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32608505 | Derived | Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2. | |
| 27094910 | Derived | Backonja U, Robledo CA, Wallace ME, Flores KF, Kiely M. Reproductive Health Knowledge among African American Women Enrolled in a Clinic-Based Randomized Controlled Trial to Reduce Psychosocial and Behavioral Risk: Project DC-HOPE. Womens Health Issues. 2016 Jul-Aug;26(4):442-51. doi: 10.1016/j.whi.2016.03.005. Epub 2016 Apr 16. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000073869 | Tobacco Smoking |
| D066088 | Infant Death |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012907 | Smoking |
| D064424 | Tobacco Use |
| D003643 |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| OTHER |
| RTI International | OTHER |
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| 21785892 | Derived | Kiely M, El-Mohandes AA, Gantz MG, Chowdhury D, Thornberry JS, El-Khorazaty MN. Understanding the association of biomedical, psychosocial and behavioral risks with adverse pregnancy outcomes among African-Americans in Washington, DC. Matern Child Health J. 2011 Dec;15 Suppl 1(Suppl 1):S85-95. doi: 10.1007/s10995-011-0856-z. |
| 21656058 | Derived | El-Mohandes AA, El-Khorazaty MN, Kiely M, Gantz MG. Smoking cessation and relapse among pregnant African-American smokers in Washington, DC. Matern Child Health J. 2011 Dec;15 Suppl 1(Suppl 1):S96-105. doi: 10.1007/s10995-011-0825-6. |
| 21565525 | Derived | Molina KM, Kiely M. Understanding depressive symptoms among high-risk, pregnant, African-American women. Womens Health Issues. 2011 Jul-Aug;21(4):293-303. doi: 10.1016/j.whi.2011.01.008. Epub 2011 May 12. |
| 20211945 | Derived | El-Mohandes AA, Kiely M, Blake SM, Gantz MG, El-Khorazaty MN. An intervention to reduce environmental tobacco smoke exposure improves pregnancy outcomes. Pediatrics. 2010 Apr;125(4):721-8. doi: 10.1542/peds.2009-1809. Epub 2010 Mar 8. |
| 20093899 | Derived | Kiely M, El-Mohandes AAE, El-Khorazaty MN, Gantz MG. An integrated intervention to reduce intimate partner violence in pregnancy: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):273-283. doi: 10.1097/AOG.0b013e3181cbd482. |
| 19786427 | Derived | El-Mohandes AA, Kiely M, Gantz MG, Blake SM, El-Khorazaty MN. Prediction of birth weight by cotinine levels during pregnancy in a population of black smokers. Pediatrics. 2009 Oct;124(4):e671-80. doi: 10.1542/peds.2008-3784. Epub 2009 Sep 28. |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |