Healthy Outcomes of Pregnancy Education

Depression Clinical Trial

Official title:

Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00381823
• Other study ID #: HOPE Study
• Secondary ID: 3U18HD0304453U18
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: September 28, 2006
• Start date: July 2001
• Est. completion date: August 2004

Study information

• Verified date: September 2006
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1750
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Depression
• Environmental Tobacco Smoke Exposure
• Partner Abuse
• Tobacco Smoking

Intervention

Behavioral:
• Cognitive Behavioral Therapy

Locations

Country	Name	City	State
United States	Howard University	Washington	District of Columbia

Sponsors (6)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Children's Research Institute, George Washington University, Georgetown University, Howard University, RTI International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of risk behaviors:
Primary	Active smoking
Primary	Environmental Tobacco Smoke Exposure
Primary	Depression
Primary	Intimate Partner Violence
Secondary	birth weight
Secondary	gestational age