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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant women reduce alcohol use by testing a new intervention against standard prenatal care. It will explore whether a motivational program, known as the "Intervention condition," can result in more women having negative alcohol tests during pregnancy and healthier babies. Participants will use a computer-based program and receive nurse support to encourage reducing alcohol consumption. Women who are less than 28 weeks pregnant and have recently consumed alcohol may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance prenatal care for future mothers.

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 prior data suggests that this intervention is safe for pregnant women?

Research has shown that motivational programs can safely and effectively help pregnant women reduce alcohol use. These programs, offering both online and in-person support, have helped many women lower the risk of alcohol exposure to their babies. For example, one study found that 69% of participants reduced their risk of alcohol-exposed pregnancies.

These programs aim to increase understanding and motivation to drink less, using safe and non-invasive methods to encourage change. Importantly, no reports of serious side effects have emerged from participation, indicating that most women find them manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a dual-component intervention to reduce alcohol exposure during pregnancy, which is different from the usual prenatal care. Unlike standard care that mainly involves clinician assessments and general counseling, this intervention combines a self-paced, computer-delivered component to boost knowledge and motivation with a personalized nurse-delivered component to address specific questions and reinforce learning. This innovative approach could lead to more effective alcohol reduction by tailoring support to individual needs and making education more engaging and accessible.

What evidence suggests that this motivational intervention is effective for reducing alcohol use during pregnancy?

Research has shown that motivational programs can help reduce alcohol use during pregnancy. In one study, 69% of women lowered their risk of having a baby exposed to alcohol after joining such a program. This trial includes an intervention condition where participants receive the usual prenatal care plus an alcohol intervention. The intervention consists of a self-paced computer-delivered component to enhance knowledge, norms, and motivation for alcohol reduction, along with a nurse-delivered component to reinforce the content and address questions. These programs typically teach about the dangers of drinking while pregnant and encourage women to stop. Self-paced learning tools, combined with nurse support, have guided women to make healthier choices. Short programs have also been somewhat successful in helping women stop drinking during pregnancy and in preventing early births. Overall, these methods aim to provide women with the information and support needed to reduce alcohol use. ^{1 2 6 7 8}

Who Is on the Research Team?

Ralph DiClemente, PhD

Principal Investigator

New York University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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 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]

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]

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]

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]

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