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
  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)

Resource links provided by NLM:


Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:
  • Effective contraception [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219336

Locations
United States, Florida
Nova Southeastern University
Fort. Lauderdale, Florida, United States, 33314
Sponsors and Collaborators
Nova Southeastern University
Investigators
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 Spectrum Disorders
Alcohol-Induced Disorders
Alcohol-Related Disorders
Fetal Diseases
Ethanol
Chemically-Induced Disorders
Drinking Behavior
Pregnancy Complications
Substance-Related Disorders
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014