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

Alcohol Exposed Pregnancy Clinical Trial

— WYSE CHOICES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376346
• Other study ID #: 18-0574
• Secondary ID: R01AA025603
• Status: Completed
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: February 25, 2024

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: February 25, 2024
• Est. primary completion date: February 25, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Exposed Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado- Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Use	Number of days in past 30 had at least one alcoholic drink.	Baseline
Primary	Alcohol Use	Number of days in past 30 had at least one alcoholic drink.	2 months
Primary	Alcohol Use	Number of days in past 30 had at least one alcoholic drink.	6 months
Primary	Alcohol Use	Number of days in past 30 had at least one alcoholic drink.	12 months
Primary	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
Primary	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
Primary	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
Primary	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