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Sponsored by: |
Nova Southeastern University |
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Information provided by: | Nova Southeastern University |
ClinicalTrials.gov Identifier: | NCT00219336 |
The study will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP) among women 18 to 44 years of age living in Florida. The investigators hypothesize that the motivational intervention will significantly reduce more women's risk of an AEP than will an informational intervention aimed at preventing fetal alcohol syndrome.
Condition | Intervention | Phase |
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Alcohol Consumption Fetal Alcohol Syndrome |
Behavioral: Self-guided Motivational Intervention Behavioral: Promoting Healthy Choices |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies (AEPs) |
Enrollment: | 355 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
A self-guided motivational intervention directed at preventing fetal alcohol syndrome (FAS) will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP).
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Behavioral: Self-guided Motivational Intervention
Using a randomized two-group design, a self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The proposed study will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP). Participants will be women 18 to 44 years of age who are at risk of an AEP.
Behavioral: Promoting Healthy Choices
Using a randomized two-group design, a self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The proposed study will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP). Participants will be women 18 to 44 years of age who are at risk of an AEP
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The proposed project will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP). Participants will be women 18 to 44 years of age who are at risk of an AEP. The community targeted will be Florida. The intervention will be based on the investigators' previous experience in promoting self-change of drinking behavior at a community level and in promoting reduced risk for AEP through the use of a motivational intervention. Using a randomized group design, the self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The FAS prevention condition will serve as a standard treatment control group in that most information available at the community level concerning the effects of alcohol on the developing fetus relate to FAS (e.g., warning labels on alcoholic beverage containers). It is suggested that many women at risk for AEP do not view themselves as at risk for FAS and therefore do not view FAS-oriented prevention messages as personally relevant. The proposed experimental design will evaluate a media-based strategy that could be easily implemented throughout communities.
The proposed study design will have more methodological rigor and allow a more careful evaluation than would be possible if the intervention was initially targeted at the entire community. If successful, the intervention results can be readily disseminated throughout the local area. Specific objectives are as follows:
Ages Eligible for Study: | 18 Years to 44 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
At risk for an alcohol exposed pregnancy 90 days prior to the interview defined as:
Exclusion Criteria:
United States, Florida | |
Nova Southeastern University | |
Fort. Lauderdale, Florida, United States, 33314 |
Principal Investigator: | Linda C Sobell, Ph.D. | Nova Southeastern University |
Responsible Party: | Dr. Linda C. sobell ( Nova SEU University ) |
Study ID Numbers: | U50/CCU300860, U50/CCU300860 |
Study First Received: | September 14, 2005 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00219336 History of Changes |
Health Authority: | United States: Institutional Review Board |
Alcohol Exposed Pregnancies Reduced Alcohol Used Self-Guided Motivational Intervention Effective Contraception Contraception |
Alcohol-Induced Disorders Fetal Diseases Fetal Alcohol Syndrome Pregnancy Complications Substance-Related Disorders |
Drinking Behavior Disorders of Environmental Origin Alcohol-Related Disorders Alcohol Drinking Ethanol |
Alcohol-Induced Disorders Fetal Diseases Fetal Alcohol Syndrome Pathologic Processes Disease Pregnancy Complications |
Syndrome Substance-Related Disorders Drinking Behavior Disorders of Environmental Origin Alcohol-Related Disorders Alcohol Drinking |