Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial
EARLY RCT
2 other identifiers
interventional
232
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 2, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedOctober 26, 2016
October 1, 2016
3.4 years
October 2, 2011
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Drinks per drinking day
6 months
Rate of effective contraception
6 months
Secondary Outcomes (1)
Alcohol Exposed Pregnancy risk
6 months
Study Arms (3)
EARLY
EXPERIMENTALMotivational Interviewing plus feedback counseling with information via video and brochures
Video Information
ACTIVE COMPARATORProviding FASD information via documentary video clips
Informational Brochure
ACTIVE COMPARATORParticipants will receive informational brochures on contraception, women and drinking, and cutting down your drinking.
Interventions
Provides an MI + feedback intervention supplemented with video and brochures-based information
Informational Brochures are given to participants following baseline assessment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UVA CARE
Charlottesville, Virginia, 22911, United States
UVA CARE
Richmond, Virginia, 23294, United States
Related Publications (6)
Ingersoll KS, Hettema JE, Cropsey KL, Jackson JP. Preconception markers of dual risk for alcohol and smoking exposed pregnancy: tools for primary prevention. J Womens Health (Larchmt). 2011 Nov;20(11):1627-33. doi: 10.1089/jwh.2010.2633. Epub 2011 Aug 12.
PMID: 21838526RESULTFabbri S, Farrell LV, Penberthy JK, Ceperich SD, Ingersoll KS. Toward prevention of alcohol exposed pregnancies: characteristics that relate to ineffective contraception and risky drinking. J Behav Med. 2009 Oct;32(5):443-52. doi: 10.1007/s10865-009-9215-6. Epub 2009 May 21.
PMID: 19459039RESULTIngersoll KS, Ceperich SD, Hettema JE, Farrell-Carnahan L, Penberthy JK. Preconceptional motivational interviewing interventions to reduce alcohol-exposed pregnancy risk. J Subst Abuse Treat. 2013 Apr;44(4):407-16. doi: 10.1016/j.jsat.2012.10.001. Epub 2012 Nov 26.
PMID: 23192220RESULTFarrell-Carnahan L, Hettema J, Jackson J, Kamalanathan S, Ritterband LM, Ingersoll KS. Feasibility and promise of a remote-delivered preconception motivational interviewing intervention to reduce risk for alcohol-exposed pregnancy. Telemed J E Health. 2013 Aug;19(8):597-604. doi: 10.1089/tmj.2012.0247. Epub 2013 Jun 13.
PMID: 23763608RESULTPenberthy JK, Hook JN, Hettema J, Farrell-Carnahan L, Ingersoll K. Depressive symptoms moderate treatment response to brief intervention for prevention of alcohol exposed pregnancy. J Subst Abuse Treat. 2013 Oct;45(4):335-42. doi: 10.1016/j.jsat.2013.05.002. Epub 2013 Jun 28.
PMID: 23810264RESULTHettema J, Cockrell S, Russo J, Corder-Mabe J, Yowell-Many A, Chisholm C, Ingersoll K. Missed Opportunities: Screening and Brief Intervention for Risky Alcohol Use in Women's Health Settings. J Womens Health (Larchmt). 2015 Aug;24(8):648-54. doi: 10.1089/jwh.2014.4961. Epub 2015 Jul 31.
PMID: 26230758RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen S Ingersoll, Ph.D.
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychiatry and Neurobehavioral Sciences
Study Record Dates
First Submitted
October 2, 2011
First Posted
October 5, 2011
Study Start
February 1, 2007
Primary Completion
July 1, 2010
Study Completion
September 1, 2011
Last Updated
October 26, 2016
Record last verified: 2016-10