Reducing Alcohol Exposed Pregnancy Risk: EARLY Randomized Controlled Trial
NCT ID: NCT01446653
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
232 participants
INTERVENTIONAL
2007-02-28
2011-09-30
Brief Summary
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Detailed Description
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Motivational interviewing focusing on the dual behaviors that compose risk for AEP is a promising approach. A five session, dual-focused motivational interviewing plus contraception counseling intervention was effective for women at risk for AEP who were not seeking treatment. Unfortunately, even though such interventions may prove effective, they are unlikely to be adopted in community settings due to their length and cost. What is needed is a less costly, transportable brief intervention that uses the effective components of these longer interventions, but delivers them in a condensed format. A briefer intervention could be used with women awaiting services or added to existing therapeutic services, and thus could have a larger public health impact on reducing the risk of AEP for women drawn from diverse settings. A single-session intervention, Project Balance, has shown evidence of efficacy with college women, but will require adaptation for less educated community-based women with more severe drinking problems or less contraception use. The next step needed to advance this field is to develop and test a less time-intensive intervention that builds on effective and theory-based interventions, and to test that intervention in women drawn from higher risk settings.
The purpose of this Stage 1b project is to develop and test the efficacy of a brief, theory-based, behavioral intervention among a high-risk community sample of fertile women who are at particularly high risk for an alcohol-exposed pregnancy (AEP). Because prevention of 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 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. The specific aims are to:
1. Develop the "Exploring Alcohol and Contraception Risks that Limit You" (EARLY) intervention, refine training methods and materials, and train therapists to deliver the intervention accurately.
2. Develop measures of the internal validity and fidelity of the intervention, and establish their psychometric properties.
3. Test the efficacy of the EARLY intervention against a minimal intervention condition that controls for the effects of assessment, time, and attention. Efficacy to retain participants, reduce drinking, and increase contraception will be tested in a pilot randomized trial of women drawn from the target populations: settings serving problem drinkers (outpatient drug and alcohol treatment settings) or women with ineffective contraceptive habits (STD and public health clinics)
4. Develop materials needed for a Stage 2 efficacy trial, including evidence of the feasibility and promise of the EARLY intervention, treatment manuals, therapist training materials, and a final instrumentation package.
5. Examine the role of variables other than group assignment (alcohol problem severity, psychiatric co-morbidity, drug use/severity, trans-theoretical model variables (readiness, stages, and processes of change, self efficacy, and therapeutic alliance) to mediate or moderate response, and examine secondary outcomes of the intervention, such as changes in readiness.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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EARLY
Motivational Interviewing plus feedback counseling with information via video and brochures
Motivational Interviewing plus feedback
Provides an MI + feedback intervention supplemented with video and brochures-based information
Video Information
Providing FASD information via documentary video clips
Video
Video arm will provide information via documentary video
Informational Brochure
Participants will receive informational brochures on contraception, women and drinking, and cutting down your drinking.
Informational Brochure
Informational Brochures are given to participants following baseline assessment.
Interventions
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Motivational Interviewing plus feedback
Provides an MI + feedback intervention supplemented with video and brochures-based information
Video
Video arm will provide information via documentary video
Informational Brochure
Informational Brochures are given to participants following baseline assessment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
44 Years
FEMALE
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of Virginia
OTHER
Responsible Party
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Karen Ingersoll
Associate Professor of Psychiatry and Neurobehavioral Sciences
Principal Investigators
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Karen S Ingersoll, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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UVA CARE
Charlottesville, Virginia, United States
UVA CARE
Richmond, Virginia, United States
Countries
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References
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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.
Fabbri 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.
Ingersoll 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.
Farrell-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.
Penberthy 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.
Hettema 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.
Other Identifiers
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12794
Identifier Type: -
Identifier Source: org_study_id