Evidence map›Paper›PMID 35922101›Full record

ArticleBMJ open2022

Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol.

Steven J Ondersma, Lisa Todd, Samantha Jablonski, Chaarushi Ahuja, Kathryn Gilstad-Hayden, Gregory Goyert, Amy Loree, Jaimee Heffner, Kimberly A Yonkers

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04332172 (Scaling Up), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04332172 nacompletednot on this mapstarted 2023, after this paper: background citation

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

TypeinterventionalSponsorMichigan State UniversityRan2023 to 2025Enrolled384ConditionsFetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Fetal Alcohol EffectArmsGeneral information, Baseline brief intervention, Remote online booster sessions, SMS
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 1 country.

Steven J OndersmaDivision of Public Health and Department of Obstetrics, Gynecology, and Reproductive Biology, Michigan State University, Flint, Michigan, USA onders12@msu.edu.
Lisa ToddFamily Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, Michigan, USA.ORCID 0000-0002-6786-0676
Samantha JablonskiHealth Care Value-Business Analytics Division, Blue Cross Blue Shield of Michigan, Detroit, Michigan, USA.
Chaarushi AhujaDepartment of Obstetrics, Gynecology, and Reproductive Science, Yale-New Haven Hospital, New Haven, Connecticut, USA.
Kathryn Gilstad-HaydenDepartment of Psychiatry, Yale School of Medicine, New Haven, Connecticut, USA.
Gregory GoyertDivision of Maternal Fetal Medicine, Henry Ford Health, Detroit, Michigan, USA.
Amy LoreeCenter for Health Policy & Health Services Research, Henry Ford Health System, Detroit, Michigan, USA.
Jaimee HeffnerDivision of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Kimberly A YonkersDepartments of Psychiatry and Obstetrics & Gynecology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Henry Ford Health System · USBlue Cross Blue Shield of Michigan Foundation · USFred Hutch Cancer Center · USMichigan State University · USUniversity of Massachusetts Chan Medical School · USWayne State University · USYale New Haven Hospital · USYale University · US

Funding

Scaling up: A multi-site trial of e-SBI for alcohol use in PregnancyR01AA026596 · NIAAA · WAYNE STATE UNIVERSITY · PI ONDERSMA, STEVEN J., YONKERS, KIMBERLY A · 2019 to 2023
$2.6M
NIAAA Short-Term Training: Students in Health Professional SchoolsT35AA023760 · NIAAA · YALE UNIVERSITY · PI HERZOG, ERICA L, KRYSTAL, JOHN H. · 2017 to 2021
$314k
NIAAA NIH HHS R01 AA026596NIAAA NIH HHS T35 AA023760
6 · The paper itself

Abstract

introductionApproximately 1 in 7 pregnant women in the USA report past-month alcohol use. Strong evidence connects prenatal alcohol exposure with a range of adverse perinatal outcomes, including the spectrum of conditions known as fetal alcohol spectrum disorders. Screening and Brief Intervention (SBI) has been recommended for pregnant women but has proven difficult to implement. This study will test the efficacy of single-session technology-delivered SBI (electronic SBI) for alcohol use in pregnancy, while simultaneously evaluating the possible additional benefit of tailored text messages and/or booster sessions in a 3×2 factorial trial. METHOD AND ANALYSIS: This full factorial trial will use online advertising and clinic-based flyers to recruit pregnant women meeting criteria for unhealthy alcohol use, and randomly assign them to one of six conditions crossing three levels of brief intervention (none, single 120-minute session and single session plus two 5-minute boosters) with two levels of tailored text messaging (none vs twice weekly messages). The primary analysis will test for dose-response effects of the brief intervention on alcohol abstinence, defined as no self-report of alcohol use in the 90 days prior to 34 weeks' gestation, and negative results for ethyl glucuronide analysis of fingernail samples. Secondary analyses will examine main and interaction effects of tailored text messaging as well as intervention effects on birth outcomes. ETHICS AND DISSEMINATION: Ethical approval was provided by the Michigan State University Biomedical and Health Institutional Review Board (STUDY00005298). Results will be presented at conferences and community forums, in addition to being published in a peer-reviewed journal. Intervention content demonstrating sufficient efficacy and safety will be made publicly available. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04332172).

Indexed as

Crisis InterventionPrenatal Exposure Delayed EffectsAlcohol DrinkingElectronicsFemaleHumansMass ScreeningPregnancyRandomized Controlled Trials as Topicclinical trialsmaternal medicineobstetricssubstance misuseWorld Wide Web technology

Identifiers

PMID35922101
PMCPMC9352990
OpenAlexW4289596147

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.