Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial

Completed · Not applicable

Conditions studied: Alcohol Exposed Pregnancy

In brief

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) will be achieved whether woman change drinking OR contraception, the primary endpoints will be rates of risky drinking and ineffective contraception at six-month follow-up, in addition to dichotomously defined "successful outcome" that will be observed whenever a woman has sufficiently altered one or both of the behaviors that placed her at risk of Alcohol-Exposed Pregnancy (AEP). The goal is to identify a transferable intervention that effectively reduces behaviors that put women at risk for AEP and alcohol-related birth defects including FASD.

Key facts

Study ID

NCT01446653

Run by

University of Virginia

People needed

232

Starts

2007-02-01

Expected to finish

2011-09-01

Last updated by the study team

2016-10-26

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UVA CARE — Charlottesville, Virginia, United States
• UVA CARE — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.