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

NCT00219336 | Completed Phase 2

• 1 other identifier: U50/CCU300860
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Alcohol Consumption; Fetal Alcohol Syndrome Disorders; Students

Keywords

Prevent Alcohol Exposed Pregnancies; Reduced Alcohol Used; Self-Guided Motivational Intervention; Effective Contraception; Contraception; College Students

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Self-motivational Choices

EXPERIMENTAL

Students and nonstudents were mailed a brochure prepared as part of the PHC study intervention, Making Healthy Choices for a Healthy Baby in English or Mujeres y Salud Eligiendo Opciones Saludables in Spanish. This brochure allows women to make informed decisions about preventing an AEP. The MF materials included nonstigmatizing messages about drinking and contraception embedded among other health messages. Similar to Project CHOICES, this group also received a brochure on birth control practices.

Behavioral: Self-guided Motivational Intervention

Information Only

ACTIVE COMPARATOR

Students and nonstudents were mailed a brochure prepared by the CDC. The brochure (English: Think Before You Drink: You Can Hurt Your Unborn Baby; Spanish: Piénselo Antes de Beber: Puede Lastimar a Su Futuro Bebe), available at the CDC website, targets women of childbearing-age, discusses FAS and the negative effects of a mother's drinking on her unborn child, and recommends calling Alcoholics Anonymous or an alcohol treatment program for help to stop drinking. The CDC brochure did not contain information about how to contracept effectively.

Behavioral: Informational Only

Interventions

Self-guided Motivational Intervention BEHAVIORAL

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.

Self-motivational Choices

Informational Only BEHAVIORAL

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

Information Only

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• had heterosexual vaginal intercourse with ineffective contraception
• not effectively using contraception
• drinking either ≥ 8 drinks per week on average or ≥ 5 drinks in a single day or both
• returned their informed consent and assessment materials within 60 days after it was mailed to them

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

Location

Related Publications (1)

• Gioia CJ, Sobell LC, Sobell MB, Agrawal S. Craigslist versus print newspaper advertising for recruiting research participants for alcohol studies: Cost and participant characteristics. Addict Behav. 2016 Mar;54:24-32. doi: 10.1016/j.addbeh.2015.11.008. Epub 2015 Nov 19.

  PMID: 26675247 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Linda C Sobell, Ph.D.

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: March 1, 2009
• Last Updated: September 30, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)