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e-Intervention for Alcohol Use in Pregnancy (e-Health Trial)

Q: Are there any specific requirements to participate in this trial?

<p>As this is a clinical trial for fetal alcohol syndrome, only those 18 to 35 years old who have been diagnosed with fetal alcohol syndrome are able to participate. Out of the total 384 accepted candidates, how many will be chosen is yet to be decided.</p>

Q: Does the age limit for this research allow for a broad population sample?

<p>In order to meet the requirements for this study, potential participants must be 18-35 years old. For patients that do not fall in this age bracket, there are 7 other trials for those under 18 and 5 for those over 65.</p>

N/A

Recruiting

Led By Steven J Ondersma, PhD

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-35 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up entire period of gestation

Awards & highlights

e-Health Trial Summary

This trial is testing a new alcohol intervention for pregnant women, to see if it reduces alcohol use and if booster sessions or text messages can help.

Who is the study for?

This trial is for pregnant women aged 18-35, less than 20 weeks along, living in Connecticut, Massachusetts, or Michigan. They must own a mobile device and have reported alcohol use that poses a risk to fetal health. Women not intending to carry the pregnancy to term or unable to communicate in English cannot participate.Check my eligibility

What is being tested?

The study tests an app called MommyCheckup designed for pregnant women at risk of alcohol-related issues. It delivers brief interventions and checks if additional booster sessions or personalized text messages can further reduce alcohol consumption during pregnancy.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like apps and text messaging, there are no direct medical side effects. However, participants may experience stress or discomfort when discussing their alcohol use.

e-Health Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 35 years old.

e-Health Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants abstinent from alcohol as measured by Timeline FollowBack Calendar Recall and Ethyl Glucuronide (EtG)

Secondary outcome measures

Number of participants with a healthy birth outcome (full-term live birth of normal birthweight, with no days in NICU)

e-Health Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: General information + SMSExperimental Treatment2 Interventions

SMS refers to tailored text messaging.

Group II: Baseline brief intervention + SMSExperimental Treatment2 Interventions

Brief technology-delivered intervention for alcohol use during pregnancy, plus tailored text messaging

Group III: Baseline brief intervention + 2 booster sessions + SMSExperimental Treatment3 Interventions

Brief technology-delivered intervention for alcohol use during pregnancy, plus two very brief (<5 minutes) online boosters using the participants' own mobile device, plus tailored SMS.

Group IV: Baseline brief intervention + 2 booster sessionsExperimental Treatment2 Interventions

Brief technology-delivered intervention for alcohol use during pregnancy, plus two very brief (<5 minutes) online boosters using the participants' own mobile device.

Group V: Baseline brief interventionExperimental Treatment1 Intervention

Brief technology-delivered intervention for alcohol use during pregnancy

Group VI: General informationPlacebo Group1 Intervention

Control

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SMS

2016

N/A

~59160

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor

185 Previous Clinical Trials

601,643 Total Patients Enrolled

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

802 Previous Clinical Trials

1,365,061 Total Patients Enrolled

14 Trials studying Fetal Alcohol Spectrum Disorders

3,277 Patients Enrolled for Fetal Alcohol Spectrum Disorders

University of Massachusetts, WorcesterOTHER

343 Previous Clinical Trials

986,226 Total Patients Enrolled

Media Library

Baseline brief intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04332172 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific requirements to participate in this trial?

"As this is a clinical trial for fetal alcohol syndrome, only those 18 to 35 years old who have been diagnosed with fetal alcohol syndrome are able to participate. Out of the total 384 accepted candidates, how many will be chosen is yet to be decided."

Answered by AI

Does the age limit for this research allow for a broad population sample?

"In order to meet the requirements for this study, potential participants must be 18-35 years old. For patients that do not fall in this age bracket, there are 7 other trials for those under 18 and 5 for those over 65."

Answered by AI

Recent research and studies

BMJ OpenJournal

Online Randomised Factorial Trial of Electronic Screening and Brief Intervention for Alcohol Use in Pregnancy: A Study Protocol

Ondersma, Steven J, Lisa Todd, Samantha Jablonski, Chaarushi Ahuja, Kathryn Gilstad-Hayden, Gregory Goyert, Amy Loree, Jaimee Heffner, and Kimberly A Yonkers. 2022. “Online Randomised Factorial Trial of Electronic Screening and Brief Intervention for Alcohol Use in Pregnancy: A Study Protocol”. BMJ Open. BMJ. doi:10.1136/bmjopen-2022-062735.

clinicaltrials.govStudy

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

Steven J. Ondersma 2023. "Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04332172.

All > Pregnancy