Risk for an Alcohol-Exposed PregnancyPhase 2NCT00153478
Project CHOICES Efficacy Study
A Phase 2 study testing Brief Motivational Counseling in people with Risk for an Alcohol-Exposed Pregnancy and Hazardous Alcohol Use, run by Centers for Disease Control and Prevention at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Risk for an Alcohol-Exposed Pregnancy, Hazardous Alcohol Use, Risk for Unintended Pregnancy
- What is being tested?
- Brief Motivational Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,200 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2002to Aug 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Inclusion Criteria: Women who: are not pregnant, are between the ages of 18 and 44 years, consume more than seven drinks per week and/or at least one binge episode (five or more drinks in one day) in the last 90 days (for the Texas jail \& recovery center sites, this will be the 90 days before entering these facilities), are able to provide and do provide informed consent, are members of the special setting's population, and are available for follow-up through 9 months after recruitment.
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Exclusion Criteria: Women who: do not meet the inclusion criteria, cannot commit to provide information about how to be contacted for follow-up, or are unable to understand spoken English.
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Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Plane State Jail
Dayton, Texas, 77030
Broward County Health District Primary Care Centers
Fort Lauderdale, Florida, 33314
Media Recruited Participants from Broward County
Fort Lauderdale, Florida, 33314
Career and Recovery
Houston, Texas, 77030
Door to Recovery
Houston, Texas, 77030
Harris County Jail
Houston, Texas, 77030
Houston Recovery Campus
Houston, Texas, 77030
New Directions
Houston, Texas, 77030
Sally's House
Houston, Texas, 77030
Medicaid Helath Maintenance Organization
Richmond, Virginia, 23298
Outpatient Gynecology Clinic-Virginia Commonwealth Univ
Richmond, Virginia, 23298
About this study
Official title: Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies
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.
Read the detailed description
Women at high risk for an AEP are define as sexually active, fertile women who are drinking more than 7 drinks per week and/or 5 or more drinks on any one day, and are noy using effective measures to prevent pregnancy. Participants will be recruited from community-based setting previously shown to have increased proportions of women at risk for AEP. Women in the intervention group (IPC) will receive 4 counselling sessions that include personal feedback on AEP risk behaviors drawn from baseline information,consequences of alcohol use in pregnancy, assessing readiness to change risk behaviors, pros and cons of risk drinking and unprotected intercourse, goal setting to reduce risk behaviors, and a consultation visit with a family planning provider to discuss appropriate choices for pregnancy prevention based on clinical assessment. Clients are counseled that there are two routes to reducing AEP risk, alcohol reduction or pregnancy prevention, with the ideal being both. Women in the control group (IO) will receive an informational brochure that addresses healthy lifestyle behaviors, including alcohol use, and a list of referral sources for health care treatment and alcohol abuse treatment. Both groups will be assessed at baseline using a full battery of measures that include alcohol and contraceptive use with follow-up measures at 3, 6, and 9 months after baseline.
- Conditions
- Risk for an Alcohol-Exposed Pregnancy, Hazardous Alcohol Use, Risk for Unintended Pregnancy
- Being tested
- Brief Motivational Counseling
- Keywords
- Alcohol-Exposed Pregnancy, Binge drinking, Frequent drinking, Unintended pregnancy, Fetal Alcohol Syndrome
- Medical subject headings
- Binge Drinking, Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational CounselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2002
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk for an Alcohol-Exposed PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Rosa L Floyd, DSN, Principal investigator, Centers for Disease Control and PreventionMark B Sobell, PhD, Principal investigator, Nova Southeastern UniversityMary V. Velasquez, PhD, Principal investigator, The University of Texas Health Science Center, HoustonKaren Ingersol, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153478
- Sponsor's protocol ID
- CDC-NCBDDD-3271
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project CHOICES Efficacy Study for Preventing Alcohol-Exposed Pregnancies
- ClinicalTrials.gov ID
- NCT00153478
- Acronym / sponsor ID
- CDC-NCBDDD-3271
- Conditions
- Risk for an Alcohol-Exposed Pregnancy, Hazardous Alcohol Use, Risk for Unintended Pregnancy
- Keywords
- Alcohol-Exposed Pregnancy, Binge drinking, Frequent drinking, Unintended pregnancy, Fetal Alcohol Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Jul 2002
- Study completion
- Aug 2004
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Women at high risk for an AEP are define as sexually active, fertile women who are drinking more than 7 drinks per week and/or 5 or more drinks on any one day, and are noy using effective measures to prevent pregnancy. Participants will be recruited from community-based setting previously shown to have increased proportions of women at risk for AEP. Women in the intervention group (IPC) will receive 4 counselling sessions that include personal feedback on AEP risk behaviors drawn from baseline information,consequences of alcohol use in pregnancy, assessing readiness to change risk behaviors, pros and cons of risk drinking and unprotected intercourse, goal setting to reduce risk behaviors, and a consultation visit with a family planning provider to discuss appropriate choices for pregnancy prevention based on clinical assessment. Clients are counseled that there are two routes to reducing AEP risk, alcohol reduction or pregnancy prevention, with the ideal being both. Women in the control group (IO) will receive an informational brochure that addresses healthy lifestyle behaviors, including alcohol use, and a list of referral sources for health care treatment and alcohol abuse treatment. Both groups will be assessed at baseline using a full battery of measures that include alcohol and contraceptive use with follow-up measures at 3, 6, and 9 months after baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Motivational Counseling | Behavioural | – |
Primary outcome
Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.
1 secondary outcome
Mediators and moderators of reduced risk in the IPC and IO groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
Related trials for Risk for an Alcohol-Exposed Pregnancy
Active, not recruiting
CHOICES-TEEN Randomized Controlled Trial
Risk for an Alcohol-Exposed Pregnancy, Risk for Marijuana-Exposed Pregnancy
Enrolling by invitation
Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or At-risk for FASD
Prenatal Alcohol Exposure, Fetal Alcohol Spectrum Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa L Floyd, DSN principal investigator
Centers for Disease Control and Prevention
Mark B Sobell, PhD principal investigator
Nova Southeastern University
Mary V. Velasquez, PhD principal investigator
The University of Texas Health Science Center, Houston
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brief Motivational Counseling in people with Risk for an Alcohol-Exposed Pregnancy and Hazardous Alcohol Use, run by Centers for Disease Control and Prevention at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced risks for AEP;reduced risk drinking and reduced episodes of unprotected intercourse.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2005.