Brief Summary

Project CHOICES Efficacy Study is a randomized controlled trial (RCT) designed to evaluate the clinical efficacy of a brief motivational intervention aimed at reducing alcohol-exposed pregnancies(AEP)in high-risk preconceptional women. The study is a multi-site collaborative study between the CDC and three universities. The hypothesis of the study is that a greater proportion of women will reduce thier risk of having an alcohol-exposed pregnancy after participating in the Information Plus Counseling (IPC) intervention than do those in the Information Only(IO) control group.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,200

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2002

Geographic Reach

1 country

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

July 1, 2002

Completed

2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed

Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 8, 2005

Conditions

Risk for an Alcohol-Exposed Pregnancy Hazardous Alcohol Use Risk for Unintended Pregnancy

Keywords

Alcohol-Exposed PregnancyBinge drinkingFrequent drinkingUnintended pregnancyFetal Alcohol Syndrome

Outcome Measures

Primary Outcomes (1)

Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.

Secondary Outcomes (1)

Mediators and moderators of reduced risk in the IPC and IO groups.

Interventions

Brief Motivational CounselingBEHAVIORAL

Eligibility Criteria

Age18 Years - 44 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Centers for Disease Control and Preventionlead

Study Sites (11)

Broward County Health District Primary Care Centers

Fort Lauderdale, Florida, 33314, United States

Location

Media Recruited Participants from Broward County

Fort Lauderdale, Florida, 33314, United States

Location

Plane State Jail

Dayton, Texas, 77030, United States

Location

Career and Recovery