Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES (WYSE CHOICES)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Alcohol Exposed Pregnancy

Treatments: Behavioral: Native WYSE CHOICES

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04376346

R01AA025603 (U.S. NIH Grant/Contract)

18-0574

Details and patient eligibility

About

Fetal Alcohol Syndrome Disorders (FASD) result in lifelong disability and are a leading cause of preventable birth defects in the US. Urban American Indian and Alaska Native (AIAN) young women are at high risk for alcohol exposed pregnancies (AEPs) which can cause FASD. In this project, the inverstigators will test the effectiveness of a culturally adapted mobile health intervention to prevent AEP, using social media to recruit AIAN young women from urban centers across the nation.

Full description

The proposed project builds on a prior NIAAA-funded project which used intensive community-based participatory research (CBPR) methods to adapt CHOICES, an evidence-based brief alcohol-exposed pregnancy (AEP) prevention intervention supported by the CDC, to American Indian Youth CHOICES (AIY-C). AIY-C contains features that make it highly amenable to mHealth approaches, including a framework for integrating diverse cultural teachings, few modules of short duration, and concrete opportunities for goal-setting and achievement. Innovative for this population is the plan to recruit young AIAN women from major urban areas in the US through social media-and to deliver AIY-C via mobile devices, increasingly ubiquitous among AIAN young adults. While social media recruitment and mHealth interventions are not new, only very recently have they been used with AIAN populations. The investigators will partner with urban AIAN organizations to guide us through social media recruitment strategies, mHealth intervention translation and implementation, and evaluation in urban AIAN settings. The investigators propose 3 specific aims: (1) Develop and pilot social-media-based recruitment strategies for urban AIAN young women; (2) translate AIY-C for mHealth delivery through an iterative and theoretically driven process and pilot the developed translated mHealth AIY-C intervention; and (3) recruit 700 (final N=525) urban AIAN young women using identified social media strategies, and conduct an RCT to rigorously evaluate the effectiveness of the mHealth translation of AIY-C for preventing AEP and FASD.

Enrollment: 439 patients

Sex: Female

Ages: 16 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Identifies as American Indian or Alaska Native (AIAN)
• Biologically female
• 16-20 years old
• Not pregnant
• Not living in tribal reservation or in an Alaska Native Village
• Live in an urban area that is at least 50,000 in population
• Not breastfeeding
• Has an email account
• Has a smart phone

Exclusion criteria

• Age 15 or younger, and 21 or older
• Biologically male
• Not AIAN
• Pregnant or breastfeeding women
• People who live on a tribal land or in communities with less than 50,000 in population
• Reside in the state of Alaska (until study obtains local IRB approval)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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439 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Participants in the intervention arm will complete the AIY-C curriculum that has been translated for mHealth delivery. This includes completing various activities such as completing their own risk assessment when it comes to AEP and setting goals for themselves.

Treatment:

Behavioral: Native WYSE CHOICES

Control Arm

No Intervention group

Description:

Participants in the control arm will complete activities that are carefully designed under different topics than the intervention arm. In this regard, participants will complete various activities such as quizzes, interactive games and videos. The investigators will ensure that participants in both arms will spend similar time on completing the activities.