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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Exposed Pregnancy
• Intervention / Treatment: Behavioral: Native WYSE CHOICES

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 439
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carol Kaufman, PhD; Phone Number: 3038807795; Email: carol.kaufman@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado- Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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.	Behavioral: Native WYSE CHOICES; Native WYSE (Women, Young, Strong, and Empowered) CHOICES (Changing High-risk alcohOl use and Increasing Contraception Effectiveness Study) is an alcohol-exposed pregnancy prevention program that translates CHOICES, an evidence-based targeted intervention, into an mHealth universal intervention for young urban American Indian/Alaska Native (AI/AN) women ages 16-20.
No Intervention: Control Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use	Number of days in past 30 had at least one alcoholic drink.	Baseline
Alcohol Use	Number of days in past 30 had at least one alcoholic drink.	2 months
Alcohol Use	Number of days in past 30 had at least one alcoholic drink.	6 months
Alcohol Use	Number of days in past 30 had at least one alcoholic drink.	12 months
Effective Contraceptive Use	Effective contraceptive use (including abstinence), measured by past 30-day vaginal sexual abstinence or, if sexually active, 30 day use of effective contraception at intercourse.	Baseline
Effective Contraceptive Use	Effective contraceptive use (including abstinence), measured by past 30-day vaginal sexual abstinence or, if sexually active, 30 day use of effective contraception at intercourse.	2 months
Effective Contraceptive Use	Effective contraceptive use (including abstinence), measured by past 30-day vaginal sexual abstinence or, if sexually active, 30 day use of effective contraception at intercourse.	6 months
Effective Contraceptive Use	Effective contraceptive use (including abstinence), measured by past 30-day vaginal sexual abstinence or, if sexually active, 30 day use of effective contraception at intercourse.	12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Carol Kaufman, PhD, University of Colorado - Anschutz Medical Campus; Principal Investigator: Michelle Sarche, PhD, University of Colorado - Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2021
• Primary Completion (Actual): February 25, 2024
• Study Completion (Actual): February 25, 2024

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 18-0574; R01AA025603 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No