Overview

This trial is active, not recruiting.

Conditions environmental tobacco smoke exposure, depression, partner abuse, tobacco smoking
Treatment cognitive behavioral therapy
Phase phase 2
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator Children's Research Institute
Start date July 2001
End date August 2004
Trial size 1750 participants
Trial identifier NCT00381823, 3U18HD030445, 3U18HD030447, 3U18HD031919, 5U18HD036104, 5U18HD31206, HOPE Study

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose educational/counseling/training

Primary Outcomes

Measure
Reduction of risk behaviors:
time frame:
Active smoking
time frame:
Environmental Tobacco Smoke Exposure
time frame:
Depression
time frame:
Intimate Partner Violence
time frame:

Secondary Outcomes

Measure
birth weight
time frame:
gestational age
time frame:

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Intervention for Risk Factors in Pregnant Women in Washington, D.C. (DC-HOPE)
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).