Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy

Summary

The purpose of this research study is to find out if pregnant women screening positive for alcohol risk like the brief alcohol intervention application that the investigators have developed (called the MommyCheckup, which is a technology-delivered SBIRT, or e-SBIRT), and if it helps them to reduce alcohol use. The investigators also wish to test whether e-SBIRT effects can be enhanced by booster sessions and/or tailored text messages.

Conditions

• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Fetal Alcohol Effect

Interventions

OTHER

General information

General information related to pregnancy is provided electronically.

BEHAVIORAL

Baseline brief intervention

Interactive brief motivational intervention is delivered electronically. Provides an introduction, describing the purpose and duration, emphasizing the non-judgmental nature of the brief intervention (BI). Uses a high-quality video featuring gain-framed messaging, quit recommendation, and testimonial from a race-matched woman; tailored on race-ethnicity, efficacy, binge frequency, and level of concern regarding her own alcohol use. The e-BI poses a question regarding the participant's willingness to avoid alcohol throughout her pregnancy. Responses to this question will sort participants into one of three major branches, each using motivational principles to promote alcohol abstinence during pregnancy.

BEHAVIORAL

Remote online booster sessions

Two \< 5-minute online e-BI boosters will be sent to participants via text link (one at 6 weeks post-baseline and one at 30 weeks gestation). The boosters will include a brief summary of the prior session in terms of the participant's concerns and goals. It will also include an assessment of her current status regarding (a) use of alcohol, and (b) intentions regarding future use of alcohol. A brief (1-2 minute) video tailored on her current status and prior goal will be provided. Finally, the boosters will contain optional goal-setting regarding reaching or maintaining abstinence.

BEHAVIORAL

SMS

Tailored text messages (SMS) will be sent to participants twice a week from baseline throughout her pregnancy (or until she opts out). The messages will be tailored on her quit status, goals, efficacy, level of concern, gestation, and perceived advantages of change. Messages will follow current state of the art regarding messaging preferences, tailoring, and gain-framing. The current list includes messages regarding fetal development, nutrition, exercise, and stress management, as well as alcohol.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of Massachusetts, Worcester

  collaborator OTHER

• Michigan State University

  lead OTHER

Principal Investigators

• Steven J Ondersma, PhD · Michigan State University

• Kimberly A Yonkers, MD · University of Massachusetts, Worcester

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-19

Primary Completion

2025-08-06

Completion

2025-08-31

Countries

• United States

Study Locations