Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial (EARLY RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01446653
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : October 26, 2016
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Karen Ingersoll, University of Virginia

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) 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.

Condition or disease Intervention/treatment Phase
Alcohol Exposed Pregnancy Behavioral: Motivational Interviewing plus feedback Behavioral: Video Behavioral: Informational Brochure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Alcohol Exposed Pregnancy Risk
Study Start Date : February 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: EARLY
Motivational Interviewing plus feedback counseling with information via video and brochures
Behavioral: Motivational Interviewing plus feedback
Provides an MI + feedback intervention supplemented with video and brochures-based information

Active Comparator: Video Information
Providing FASD information via documentary video clips
Behavioral: Video
Video arm will provide information via documentary video

Active Comparator: Informational Brochure
Participants will receive informational brochures on contraception, women and drinking, and cutting down your drinking.
Behavioral: Informational Brochure
Informational Brochures are given to participants following baseline assessment.

Primary Outcome Measures :
  1. Drinks per drinking day [ Time Frame: 6 months ]
  2. Rate of effective contraception [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Alcohol Exposed Pregnancy risk [ Time Frame: 6 months ]
    Risk for AEP is defined as the proportion of women who no longer meet the entry criteria for the trial based on her use of alcohol and unprotected intercourse, measured via the TLFB. Specifically, this means that the woman is 1) no longer at risk for pregnancy due to perfect contraception or abstinence; and/or 2) is drinking at or below recommended levels (<8drinks per week with no binges).

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01446653

United States, Virginia
Charlottesville, Virginia, United States, 22911
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
University of Virginia
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Karen S Ingersoll, Ph.D. University of Virginia

Publications of Results:

Responsible Party: Karen Ingersoll, Associate Professor of Psychiatry and Neurobehavioral Sciences, University of Virginia Identifier: NCT01446653     History of Changes
Other Study ID Numbers: 12794
R01AA014356 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Karen Ingersoll, University of Virginia:
Fetal Alcohol Spectrum Disorders
AEP risk
binge drinking
ineffective contraception

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs