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

Alcohol Consumption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219336
• Other study ID #: U50/CCU300860
• Secondary ID: U50/CCU300860
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2005
• Last updated: September 29, 2016
• Start date: November 2005
• Est. completion date: March 2009

Study information

• Verified date: September 2016
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study evaluated the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) with female students and non-students 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. Materials will be available in Spanish and English

Description:

The proposed project will evaluate the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies (AEP) among students and non-students. Participants will be women 18 to 44 years of age who are at risk of an AEP. The community targeted will be the state of Florida. Materials were available in Spanish and English The intervention will be based on the investigators' previous experience in (a) promoting self-change of drinking behavior at a community level and (b) preventing reduced risk for AEP through the use of a motivational interventional materials used in Project CHOICES. Using a 2 group randomized design, the self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The FAS prevention condition, a brochure developed by the CDC, served as the 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, particularly college students, 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 mail-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. The follow-up will be the entire 6-months post-intervention.If successful, this low-cost intervention 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 using the 3 primary outcome measures in previous Project CHOICES studies: (a) AEP reduced risk through reduced drinking or effective contraception, or both; (b) AEP reduced risk through drinking only; and (c) reduced risk through effective contraception only.

4. Disseminate results of the study to health care providers in the local community.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: March 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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. had heterosexual vaginal intercourse with ineffective contraception

2. not effectively using contraception

3. drinking either = 8 drinks per week on average or = 5 drinks in a single day or both

4. returned their informed consent and assessment materials within 60 days after it was mailed to them

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome Disorders
• Students

Intervention

Behavioral:
• Self-guided Motivational Intervention
Using a randomized two-group design, a self-guided motivational intervention based on Project CHOICES will be compared to an informational only intervention, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS.
• Informational Only
Using a randomized two-group design, an informational intervention using a brochure from the CDC will be compared to a self-guided motivational intervention based on Project CHOICES, both directed at preventing alcohol-exposed pregnancies (AEPs) with students and nonstudents. Participants will be women 18 to 44 years of age who are at risk of an AEP. All materials are sent to participants through the USPS

Locations

Country	Name	City	State
United States	Nova Southeastern University	Fort. Lauderdale	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEP reduced risk through reduced drinking and effective contraception, or both	Not at risk if a women reported no risky drinking (see definition in outcome 2) or contracepting effectively, or both	6 months post intervention	No
Primary	AEP reduced risk through reduced drinking only	Reduced risk drinking defined as = 7 standard drinks (SDs) per week and = 4 SDs on any day during the 6-month follow-up interval; 1 SD = 14 g absolute alcohol.	6 months post intervention	No
Primary	AEP reduced risk through effective contraception only	The effectiveness of birth control methods was evaluated using algorithms (e.g., If you missed a pill during this time period, did you take both pills the next day and did you use a back up method other than rhythm or withdrawal until you started your next packet of pills?) from Project CHOICES	6 months post intervention	No