A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)
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Purpose
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 |
|---|---|---|
|
Alcohol Consumption Fetal Alcohol Syndrome |
Behavioral: Self-guided Motivational Intervention Behavioral: Promoting Healthy Choices |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies (AEPs) |
- Effective contraception [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
- Alcohol use [ Time Frame: 6 months postintervention ] [ Designated as safety issue: No ]
| Enrollment: | 355 |
| Study Start Date: | November 2005 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
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
|
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:
- Develop an evidence-based intervention to reduce alcohol-exposed pregnancies that can be easily disseminated at a community level through the mail and other media outlets.
- Implement the AEP prevention intervention using a randomized controlled trial with women recruited from a community at higher than normal risk for AEPs.
- Evaluate the efficacy of the AEP prevention intervention for reducing AEP risk as compared to a community level intervention aimed at preventing FAS.
- Disseminate results of the study to health care providers in the local community.
Eligibility| Ages Eligible for Study: | 18 Years to 44 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women aged 18 to 44 years who are not pregnant, not trying to become pregnant, and able to bear children.
At risk for an alcohol exposed pregnancy 90 days prior to the interview defined as:
- heterosexually active,
- not effectively using contraception, and
- drinking either ≥ 8 drinks per week on average or ≥ 5 drinks in a single day or both.
Exclusion Criteria:
- No alcohol consumption or vaginal intercourse in the 90 days prior to the interview
- Pregnant
- Trying to become pregnant
- Not able to bear children
- Using contraception effectively
Contacts and Locations| United States, Florida | |
| Nova Southeastern University | |
| Fort. Lauderdale, Florida, United States, 33314 | |
| Principal Investigator: | Linda C Sobell, Ph.D. | Nova Southeastern University |
More Information
No publications provided
| Responsible Party: | Nova SEU University, Dr. Linda C. sobell |
| ClinicalTrials.gov Identifier: | NCT00219336 History of Changes |
| Other Study ID Numbers: | U50/CCU300860, U50/CCU300860 |
| Study First Received: | September 14, 2005 |
| Last Updated: | September 21, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nova Southeastern University:
|
Alcohol Exposed Pregnancies Reduced Alcohol Used Self-Guided Motivational Intervention Effective Contraception Contraception |
Additional relevant MeSH terms:
|
Alcohol Drinking Fetal Alcohol Syndrome Drinking Behavior Fetal Diseases Pregnancy Complications Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders |
Ethanol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013