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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karen Ingersoll, University of Virginia
ClinicalTrials.gov Identifier:
NCT01446653
First received: October 2, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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 Intervention
Alcohol Exposed Pregnancy
Behavioral: Motivational Interviewing plus feedback
Behavioral: Video
Behavioral: Informational Brochure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Alcohol Exposed Pregnancy Risk

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Drinks per drinking day [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Rate of effective contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alcohol Exposed Pregnancy risk [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 232
Study Start Date: February 2007
Study Completion Date: September 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446653

Locations
United States, Virginia
UVA CARE
Charlottesville, Virginia, United States, 22911
UVA CARE
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Karen S Ingersoll, Ph.D. University of Virginia
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Ingersoll, Associate Professor of Psychiatry and Neurobehavioral Sciences, University of Virginia
ClinicalTrials.gov Identifier: NCT01446653     History of Changes
Other Study ID Numbers: 12794, R01AA014356
Study First Received: October 2, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014