Alcohol Reduction Program for Preventing Alcohol Exposure During Pregnancy

Overseen By Rebecca Lunstroth

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Under 18, Not pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing alcohol use during pregnancy.

What data supports the effectiveness of this treatment for preventing alcohol exposure during pregnancy?

Research shows that motivational interventions can help reduce the risk of alcohol-exposed pregnancies. For example, a study found that 69% of women reduced their risk for an alcohol-exposed pregnancy through motivational intervention, with the most success among those with lower initial alcohol consumption. ^{1 2 3 4 5}

Is the Alcohol Reduction Program for Preventing Alcohol Exposure During Pregnancy safe for humans?

The Alcohol Reduction Program, which includes motivational interviewing and brief interventions, has been used safely in pregnant women to reduce alcohol consumption. These interventions are recommended by health professionals and have not shown any safety concerns in the studies reviewed. ^{2 3 4 6 7}

How does the Motivational Intervention treatment for preventing alcohol exposure during pregnancy differ from other treatments?

The Motivational Intervention treatment is unique because it combines motivational interviewing with a stepped-care approach, allowing healthcare providers to tailor interventions to individual needs and reduce alcohol consumption during pregnancy. This approach is adaptable for busy medical settings and focuses on motivating women to change their drinking behavior, which is different from more traditional methods that may not address individual motivation. ^{2 4 6 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to compare an active intervention versus a standard of care control in reducing alcohol use among pregnant women. The main questions it aims to answer are whether a motivational intervention can: 1. increase the proportion of women detected with a laboratory-confirmed negative phosphatidylethanol (PEth) test during pregnancy, and 2. reduce the proportion of adverse birth outcomes among infants. Participants will be offered (1) a self-paced computer-delivered alcohol reduction intervention to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions. Both components are theory-driven, based on Motivational Enhancement Theory (MET), and use motivational strategies to promote alcohol reduction.

Research Team

Ralph DiClemente, PhD

Principal Investigator

New York University

Eligibility Criteria

This trial is for pregnant women over 18, less than 8 weeks into their pregnancy, who have used alcohol in the last 21 days. It's not for those under 18, not pregnant or more than 8 weeks pregnant, and without recent alcohol use.

Inclusion Criteria

Recent alcohol use as assessed by a positive EtG or self-report of alcohol use in the previous 21 days

Gestational age is 8 weeks or less

Exclusion Criteria

No recent alcohol use

Not pregnant or gestational age over 8 weeks

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Eligible women complete a baseline assessment including an Audio Computer-Assisted Self Interview (ACASI) and collection of bloodspots for phosphatidylethanol (PEth) analysis

1 week

1 visit (in-person)

Intervention

Participants receive a self-paced computer-delivered alcohol reduction intervention and a nurse-delivered component to reinforce the content

6 months

3 visits (in-person) during baseline, 2nd, and 3rd trimester assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of birth outcomes

6 months post-enrollment

Treatment Details

Interventions

• Intervention condition

Trial Overview The study tests if a computer-based program plus nurse support can help reduce drinking during pregnancy better than usual care. It uses motivational strategies to change behavior and aims to improve birth outcomes by decreasing positive PEth tests.

Participant Groups

Group I: Intervention condition, the usual prenatal care plus the alcohol intervention Experimental Treatment 1 Intervention

The alcohol intervention consists of (1) a self-paced computer-delivered component to enhance knowledge, norms, and motivation for alcohol reduction and (2) a nurse-delivered component to reinforce the computer-delivered content and address women's questions.

Group II: Comparison condition, usual prenatal care only Active Control 1 Intervention

Prenatal usual care involves clinicians assessing alcohol use and counseling women on alcohol-related risks.

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Health Resources in Action, Inc.

Collaborator

Trials

5

Recruited

2,000+

Purdue University

Collaborator

Trials

239

Recruited

72,200+

Findings from Research

A brief intervention consisting of 10- to 15-minute counseling sessions significantly increased the likelihood of pregnant women achieving alcohol abstinence, with those receiving the intervention being 5 times more likely to report abstinence compared to those who only received assessment.

Newborns of mothers who participated in the brief intervention had better outcomes, including higher birth weights and lengths, and a 3 times lower fetal mortality rate (0.9%) compared to those in the assessment-only group (2.9%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief intervention for alcohol use by pregnant women. O'Connor, MJ., Whaley, SE.[2022]

A significant portion of pregnant women in the U.S. engage in alcohol consumption, with 500,000 reporting drinking in the month before the study, which poses risks for fetal alcohol syndrome and neurodevelopmental disorders.

In a pilot study (Project CHOICES), 69% of women at high risk for alcohol-exposed pregnancies successfully reduced their risk, with those who had lower baseline drinking levels achieving the highest success rates primarily through effective contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational intervention to reduce alcohol-exposed pregnancies--Florida, Texas, and Virginia, 1997-2001. [2013]

A five-session motivational interviewing (MI) intervention significantly reduced the risk of alcohol-exposed pregnancies (AEP) among 165 women at risk, with a notable decline in AEP risk observed at both 3 months (50% to 24.59%) and 12 months (50.82% to 28.12%).

The intervention demonstrated a strong effectiveness, with an odds ratio of 2.64 for no longer being at risk of AEP at 12 months, suggesting that MI could be a valuable addition to routine primary care services for similar high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of motivational interviewing to prevent risk for an alcohol-exposed pregnancy in the Western Cape, South Africa. Rendall-Mkosi, K., Morojele, N., London, L., et al.[2013]

A community-based pilot program aimed at reducing alcohol consumption among pregnant mothers has shown a high compliance rate of 94% with no alcohol-positive breath samples from the four participants treated.

The program utilizes daily breath sample submissions with monetary incentives, demonstrating potential effectiveness in promoting healthy behaviors during pregnancy and plans to expand its reach and improve monitoring methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-I nitiated Pilot Program "My Baby's Breath" to Reduce Prenatal Alcohol Use. Washio, Y., Frederick, J., Archibald, A., et al.[2018]

A comprehensive program at the Tuba City Indian Medical Center successfully engaged 81% of high-risk women referred for preventing Fetal Alcohol Syndrome, with 39 out of 48 women participating.

By 18 months into the program, 17 women reported alcohol abstinence, and 85.7% of pregnant participants achieved abstinence by their third trimester, highlighting the program's effectiveness in reducing alcohol consumption during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive local program for the prevention of fetal alcohol syndrome. Masis, KB., May, PA.[2018]

Binge drinking during pregnancy can lead to severe outcomes for the fetus, including fetal alcohol syndrome and various developmental disorders, but these effects are preventable through early identification of alcohol consumption.

The T-ACER3 screening tool has shown high sensitivity and specificity for detecting risk drinking in pregnant women, and brief interventions involving motivational interviewing can significantly reduce alcohol consumption, making routine screening and intervention essential in prenatal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol use in pregnancy: insights in screening and intervention for the clinician. Jones, TB., Bailey, BA., Sokol, RJ.[2013]

A computer-delivered brief intervention for pregnant women at risk of alcohol use was found to be highly acceptable and easy to use, with ratings between 4.7 and 5.0 on a scale of 1 to 5.

While both the intervention and assessment-only groups reduced alcohol consumption, the infants born to women in the intervention group had significantly higher birth weights, suggesting a potential positive impact of the intervention on fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized phase I trial of a brief computer-delivered intervention for alcohol use during pregnancy. Tzilos, GK., Sokol, RJ., Ondersma, SJ.[2021]

Interventions by obstetric caregivers, such as brief interventions and motivational interviewing, have been shown to effectively reduce alcohol consumption among women, even those who drink heavily, before, during, and after pregnancy.

Implementing a stepped-care approach allows healthcare providers to deliver these interventions efficiently, helping to prevent drinking during pregnancy while managing costs and clinic resources effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interventions in prenatal clinics. Handmaker, NS., Wilbourne, P.[2023]

In a study of 132 pregnant women, both an intervention group (58 women) receiving counseling and a control group (74 women) showed significant reductions in alcohol consumption during pregnancy, with 66% abstaining completely.

The reduction in alcohol use occurred independently of the counseling intervention, suggesting that pregnancy itself may motivate women to decrease or stop alcohol consumption, highlighting the need for structured counseling at early prenatal visits for those at higher risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate alcohol consumption--need for intervention programs in pregnancy? Meberg, A., Halvorsen, B., Holter, B., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Brief intervention for alcohol use by pregnant women. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Motivational intervention to reduce alcohol-exposed pregnancies--Florida, Texas, and Virginia, 1997-2001. [2013]

3. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of motivational interviewing to prevent risk for an alcohol-exposed pregnancy in the Western Cape, South Africa. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Community-I nitiated Pilot Program "My Baby's Breath" to Reduce Prenatal Alcohol Use. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A comprehensive local program for the prevention of fetal alcohol syndrome. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Alcohol use in pregnancy: insights in screening and intervention for the clinician. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

A randomized phase I trial of a brief computer-delivered intervention for alcohol use during pregnancy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Motivational interventions in prenatal clinics. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Moderate alcohol consumption--need for intervention programs in pregnancy? [2019]