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

NCT04376346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2025-10-16

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Carol Kaufman, PhD · University of Colorado, Denver

  • Michelle Sarche, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-04
Primary Completion
2024-02-25
Completion
2024-02-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04376346 on ClinicalTrials.gov