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Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial

NCT01446653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2016-10-26

No results posted yet for this study

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) 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.

Conditions

  • Alcohol Exposed Pregnancy

Interventions

BEHAVIORAL

Motivational Interviewing plus feedback

Provides an MI + feedback intervention supplemented with video and brochures-based information

BEHAVIORAL

Video

Video arm will provide information via documentary video

BEHAVIORAL

Informational Brochure

Informational Brochures are given to participants following baseline assessment.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Karen S Ingersoll, Ph.D. · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-07-31
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01446653 on ClinicalTrials.gov