Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial
Public ClinicalTrials.gov record NCT01446653. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Reducing Alcohol Exposed Pregnancy Risk
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01446653
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 232 participants
Conditions and interventions
Conditions
Interventions
- Motivational Interviewing plus feedback Behavioral
- Video Behavioral
- Informational Brochure Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years to 44 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2007
- Primary completion
- Jun 30, 2010
- Completion
- Aug 31, 2011
- Last update posted
- Oct 25, 2016
2007 – 2011
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UVA CARE | Charlottesville | Virginia | 22911 | — |
| UVA CARE | Richmond | Virginia | 23294 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01446653, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 25, 2016 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01446653 live on ClinicalTrials.gov.