A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)
| Tracking Information | |||||
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| First Received Date ICMJE | September 14, 2005 | ||||
| Last Updated Date | September 21, 2009 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Effective contraception [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00219336 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Alcohol use [ Time Frame: 6 months postintervention ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs) | ||||
| Official Title ICMJE | A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies (AEPs) | ||||
| Brief Summary | 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. |
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| Detailed Description | 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:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Experimental: 1
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).
Interventions:
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 355 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 44 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00219336 | ||||
| Other Study ID Numbers ICMJE | U50/CCU300860, U50/CCU300860 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nova SEU University, Dr. Linda C. sobell | ||||
| Study Sponsor ICMJE | Nova Southeastern University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nova Southeastern University | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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