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

NCT04376346 | Completed Results DMC

• 2 other identifiers: 18-0574R01AA025603
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Exposed Pregnancy

Outcome Measures

Primary Outcomes (8)

• Alcohol Use

  Had at least one alcoholic drink in past 30 days (Y/N)

  Baseline

• Alcohol Use

  Had at least one alcoholic drink in past 30 days (Y/N)

  1 month

• Alcohol Use

  Had at least one alcoholic drink in past 30 days (Y/N)

  6 months

• Alcohol Use

  Had at least one alcoholic drink in past 30 days (Y/N)

  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.

  1 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

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

Native WYSE CHOICES BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Identifies as American Indian or Alaska Native (AIAN)
• Biologically female
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• Reed ND, Sarche M, Shrestha U, Bull S, Howley CT, Shangreau C, Asdigian NL, Vossberg RL, Leon JS, Kaufman CE. Creating a Virtual Indigenist Community-Based Participatory Approach: Lessons Learned from Centering Urban Native Young Women in Research. Advers Resil Sci. 2023 Dec;4(4):423-433. doi: 10.1007/s42844-023-00114-z. Epub 2023 Sep 30.

  PMID: 40766111 DERIVED

• Reed ND, Bull S, Shrestha U, Sarche M, Kaufman CE. Combating Fraudulent Participation in Urban American Indian and Alaska Native Virtual Health Research: Protocol for Increasing Data Integrity in Online Research (PRIOR). JMIR Res Protoc. 2024 Jun 13;13:e52281. doi: 10.2196/52281.

  PMID: 38869930 DERIVED

Results Point of Contact

• Title: Carol Kaufman
• Organization: Centers for American Indian and Alaska Native Health, University of Colorado Anschutz Medical Campus

carol.kaufman@cuanschutz.edu

303-880-7795

Study Officials

• Carol Kaufman, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Michelle Sarche, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 6, 2020
• Study Start: August 4, 2021
• Primary Completion: February 25, 2024
• Study Completion: February 25, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)