A virtual randomized controlled trial of an alcohol-exposed pregnancy prevention mobile app with urban American Indian and Alaska Native young women: Native WYSE CHOICES rationale, design, and methods
Authors: Carol E. Kaufman et al.
Journal: Contemporary Clinical Trials
Publication Year: May 2023
Keywords: Cultural Sensitivity and Appropriateness, Data Collection, Pregnancy, Programmatic Initiatives, Substance Use, Culturally Informed Care
Abstract:
Background
Fetal Alcohol Spectrum Disorders (FASD) result in lifelong disability and are a leading cause of preventable birth defects in the US, including for American Indian and Alaska Natives (AIANs). Prevention of alcohol exposed pregnancies (AEPs), which can cause FASD, is typically aimed at adult women who are risky drinkers and have unprotected sex. Among AIANs, AEP prevention research has been primarily conducted in reservation communities, even though over 70% of AIANs live in urban areas. Culturally appropriate AEP prevention for urban AIAN young women, regardless of current drinking or sexual behaviors, may maximize the potential for primary prevention at the beginning of the reproductive years for this underserved population.
Methods
We developed a virtual randomized controlled trial (RCT) – fully implemented through technology – to evaluate Native WYSE CHOICES, a culturally tailored mobile app, with urban AIAN young women ages 16–20 nationally. While virtual RCTs are not new, this is the first engaging a solely urban AIAN population, historically excluded from research. Participants are recruited on a rolling basis through the project social media community, organizational partnerships, and in-person events. Eligible participants complete a baseline survey and are randomized to either the app's intervention or comparison arm – each of which provide about 3 h of content. Follow-up data are collected at 1-, 6-, and 12-months post-baseline.
Results
Our study offers a template for building trust and extending reach to this underserved population while also providing important lessons and insights on advances in virtual or hybrid research approaches.
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Source: Link to Original Article.
Type of Resource: Peer-reviewed scientific article