Skip to main content
OpenTrials
Completed

NCT Number: NCT04376346

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Exposed Pregnancy

Age range

16 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Alcohol Use

    Time frame: Baseline

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

  2. Alcohol Use

    Time frame: 1 month

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

  3. Alcohol Use

    Time frame: 6 months

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

  4. Alcohol Use

    Time frame: 12 months

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

  5. Effective Contraceptive Use

    Time frame: Baseline

    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. Effective Contraceptive Use

    Time frame: 1 months

    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.

  7. Effective Contraceptive Use

    Time frame: 6 months

    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.

  8. Effective Contraceptive Use

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: WYSE CHOICES

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 6, 2020
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.