Status:
COMPLETED
Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Exposed Pregnancy
Eligibility:
FEMALE
18-44 years
Phase:
NA
Brief Summary
The EARLY Randomized Controlled Trial (RCT) will test the finalized EARLY preventive intervention against one comparison and one control condition. Because prevention of Alcohol-exposed pregnancy (AEP...
Detailed Description
Drinking women are at risk for alcohol-exposed pregnancy (AEP) if they use contraception ineffectively. Binge drinking among women of childbearing age has increased, and risky frequent drinking has re...
Eligibility Criteria
Inclusion
- ages 18-44
- fertile
- can provide informed consent
- had vaginal intercourse with a man in the past 3 months
- uses ineffective or no contraception
- speaks and reads English
- reports drinking more than seven standard drinks per week on average or more than one binge drinking episode (more than 3 standard drinks on one occasion) during the past 3 months
- if opioid dependent with recent use, is enrolled in opiate agonist treatment
- planning to remain available for the follow-up period
Exclusion
- pregnancy
- cognitive disorders including mental retardation, dementia, or active -psychosis that could impair ability to understand the intervention material or give informed consent
- current Major Depressive Disorder that could diminish responsiveness to interventions focused on promoting change
- currently opioid dependent with active use and not engaged in opiate agonist treatment
- concurrently participating in another behavioral intervention study during the study period targeting drinking or contraception efficacy that could interfere with or augment the intervention in the EARLY project.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT01446653
Start Date
February 1 2007
End Date
September 1 2011
Last Update
October 26 2016
Active Locations (2)
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1
UVA CARE
Charlottesville, Virginia, United States, 22911
2
UVA CARE
Richmond, Virginia, United States, 23294