Online randomised factorial trial of electronic Screening and Brief Intervention for alcohol use in pregnancy: a study protocol.
World Wide Web technology
clinical trials
maternal medicine
obstetrics
substance misuse
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
03 08 2022
03 08 2022
Historique:
entrez:
3
8
2022
pubmed:
4
8
2022
medline:
6
8
2022
Statut:
epublish
Résumé
Approximately 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. 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. 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. ClinicalTrials.gov Registry (NCT04332172).
Identifiants
pubmed: 35922101
pii: bmjopen-2022-062735
doi: 10.1136/bmjopen-2022-062735
pmc: PMC9352990
doi:
Banques de données
ClinicalTrials.gov
['NCT04332172']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e062735Subventions
Organisme : NIAAA NIH HHS
ID : R01 AA026596
Pays : United States
Organisme : NIAAA NIH HHS
ID : T35 AA023760
Pays : United States
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: JH has received research support from Pfizer. The authors declare that there are no other conflicts to report.
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