A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)

This study has been completed.
Sponsor:
Information provided by:
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT00219336
First received: September 14, 2005
Last updated: September 21, 2009
Last verified: September 2009

September 14, 2005
September 21, 2009
November 2005
July 2008   (final data collection date for primary outcome measure)
Effective contraception [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
  • Effective contraception
  • Significantly fewer alcohol exposed pregnancies
  • Reduced alcohol use
Complete list of historical versions of study NCT00219336 on ClinicalTrials.gov Archive Site
Alcohol use [ Time Frame: 6 months postintervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies (AEPs)
A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies (AEPs)

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.

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:

  1. 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.
  2. Implement the AEP prevention intervention using a randomized controlled trial with women recruited from a community at higher than normal risk for AEPs.
  3. Evaluate the efficacy of the AEP prevention intervention for reducing AEP risk as compared to a community level intervention aimed at preventing FAS.
  4. Disseminate results of the study to health care providers in the local community.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Alcohol Consumption
  • Fetal Alcohol Syndrome
  • 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
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:
  • Behavioral: Self-guided Motivational Intervention
  • Behavioral: Promoting Healthy Choices
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
355
March 2009
July 2008   (final data collection date for primary outcome measure)

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:

    1. heterosexually active,
    2. not effectively using contraception, and
    3. 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
Female
18 Years to 44 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219336
U50/CCU300860, U50/CCU300860
No
Nova SEU University, Dr. Linda C. sobell
Nova Southeastern University
Not Provided
Principal Investigator: Linda C Sobell, Ph.D. Nova Southeastern University
Nova Southeastern University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP