Environmental Tobacco Smoke ExposurePhase 2NCT00381823
Healthy Outcomes of Pregnancy Education
A Phase 2 study testing Cognitive Behavioral Therapy in people with Environmental Tobacco Smoke Exposure and Depression, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Environmental Tobacco Smoke Exposure, Depression, Partner Abuse
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,750 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Aug 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard University
Washington D.C., District of Columbia, 20059
About this study
Official title: Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
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.
Read the detailed description
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.
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Pregnant women, Intervention Studies, African Americans, Infant Mortality, Environmental Tobacco Smoke Pollution, Depression, Partner Abuse, Tobacco Smoke
- Medical subject headings
- Depression, Tobacco Smoking, Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of risk behaviors:
Active smoking
Environmental Tobacco Smoke Exposure
Depression
Intimate Partner Violence
Secondary outcomes (2)
birth weight
gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startJul 2001
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Environmental Tobacco Smoke ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,750 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Children's National Research Institute, Georgetown University, George Washington University, Howard University, RTI International
- Investigators
- Michele Kiely, DrPH, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381823
- Sponsor's protocol ID
- HOPE Study
- Other IDs
- 3U18HD030445, 3U18HD030447, 5U18HD031206, 3U18HD031919, 5U18HD036104
- Status last verified
- Sep 2006
- First submitted
- 26 Sep 2006
- Last updated
- 29 Sep 2006
- Results posted
- No
Publications
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.
PubMed 32608505Backonja 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.
PubMed 27094910Kiely 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.
PubMed 21785892El-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.
PubMed 21656058Molina 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.
PubMed 21565525El-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.
PubMed 20211945Kiely 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.
PubMed 20093899El-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.
PubMed 19786427
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
- ClinicalTrials.gov ID
- NCT00381823
- Acronym / sponsor ID
- HOPE Study
- Keywords
- Pregnant women, Intervention Studies, African Americans, Infant Mortality, Environmental Tobacco Smoke Pollution, Depression, Partner Abuse, Tobacco Smoke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,750 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Children's National Research Institute, Georgetown University, George Washington University, Howard University, RTI International
- Study start
- Jul 2001
- Study completion
- Aug 2004
- First posted
- 28 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy | Behavioural | – |
Primary outcome
Reduction of risk behaviors:
Active smoking
Environmental Tobacco Smoke Exposure
Depression
Intimate Partner Violence
2 secondary outcomes
birth weight
gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2006.
- Derived from this study: PubMed 32608505Hameed 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.
- Derived from this study: PubMed 27094910Backonja 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.
- Derived from this study: PubMed 21785892Kiely 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.
- Derived from this study: PubMed 21656058El-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.
- Derived from this study: PubMed 21565525Molina 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.
- Derived from this study: PubMed 20211945El-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.
- Derived from this study: PubMed 20093899Kiely 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.
- Derived from this study: PubMed 19786427El-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Kiely, DrPH study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Behavioral Therapy in people with Environmental Tobacco Smoke Exposure and Depression, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of risk behaviors:. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00381823, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2006.