NCT00381823

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,750

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
Last Updated

September 29, 2006

Status Verified

September 1, 2006

First QC Date

September 26, 2006

Last Update Submit

September 28, 2006

Conditions

Environmental Tobacco Smoke ExposureDepressionPartner AbuseTobacco Smoking

Keywords

Pregnant womenIntervention StudiesAfrican AmericansInfant MortalityEnvironmental Tobacco Smoke PollutionDepressionPartner AbuseTobacco Smoke

Outcome Measures

Primary Outcomes (5)

  • Reduction of risk behaviors:

  • Active smoking

  • Environmental Tobacco Smoke Exposure

  • Depression

  • Intimate Partner Violence

Secondary Outcomes (2)

  • birth weight

  • gestational age

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American or Latina (by self report)
  • At least 18 years of age
  • English speaking
  • Pregnant less than or equal to 28 weeks gestation
  • Receiving prenatal care in the District of Columbia
  • Had one or more of the following risk factors: active smoking, environmental tobacco smoke exposure, depression and intimate partner violence

You may not qualify if:

  • Non-minority race (by self report)
  • Younger than 18 years of age
  • Non-English speaking
  • Not pregnant or pregnant greater than 28 weeks gestation
  • Receiving prenatal care outside the District of Columbia
  • Responded negatively to questions about risk factors
  • Suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard University

Washington D.C., District of Columbia, 20059, United States

Location

Related Publications (8)

  • 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.

    PMID: 32608505DERIVED

  • 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.

    PMID: 27094910DERIVED

  • 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.

    PMID: 21785892DERIVED

  • 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.

    PMID: 21656058DERIVED

  • 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.

    PMID: 21565525DERIVED

  • 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.

    PMID: 20211945DERIVED

  • 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.

    PMID: 20093899DERIVED

  • 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.

    PMID: 19786427DERIVED

MeSH Terms

Conditions

DepressionTobacco SmokingInfant Death

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSmokingTobacco UseDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michele Kiely, DrPH

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 28, 2006

Study Start

July 1, 2001

Study Completion

August 1, 2004

Last Updated

September 29, 2006

Record last verified: 2006-09

Locations

US(1)