Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial (EARLY RCT)
This study has been completed.
Sponsor:
University of Virginia
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
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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
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 May 19, 2013