Alcohol Exposed PregnancyWYSE CHOICESNCT04376346
Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES
A study testing Native WYSE CHOICES in people with Alcohol Exposed Pregnancy, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 20 years, women only
- Conditions the study is for
- Alcohol Exposed Pregnancy
- What is being tested?
- Native WYSE CHOICES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 25 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- Not breastfeeding
- Has an email account
- Has a smart phone
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Alcohol Exposed Pregnancy
- Being tested
- Native WYSE CHOICES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native WYSE CHOICESBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use
Had at least one alcoholic drink in past 30 days (Y/N)
Measured: Baseline
Alcohol Use
Had at least one alcoholic drink in past 30 days (Y/N)
Measured: 1 month
Alcohol Use
Had at least one alcoholic drink in past 30 days (Y/N)
Measured: 6 months
Alcohol Use
Had at least one alcoholic drink in past 30 days (Y/N)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start4 Aug 2021
- Primary completion25 Feb 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Exposed PregnancyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Carol Kaufman, PhD, Principal investigator, University of Colorado, DenverMichelle Sarche, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376346
- Sponsor's protocol ID
- 18-0574
- Other IDs
- R01AA025603
- Acronym
- WYSE CHOICES
- Status last verified
- Sep 2025
- First submitted
- 14 Apr 2020
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40766111Reed 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.
PubMed 38869930
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES
- ClinicalTrials.gov ID
- NCT04376346
- Acronym / sponsor ID
- WYSE CHOICES / 18-0574
- Conditions
- Alcohol Exposed Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Posted 16 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Native WYSE CHOICESParticipants 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. |
| 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. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Native WYSE CHOICESNative 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. | Behavioural | Intervention Arm |
Primary outcome
Alcohol Use
Time frame: Baseline
Had at least one alcoholic drink in past 30 days (Y/N)
Alcohol Use
Time frame: 1 month
Had at least one alcoholic drink in past 30 days (Y/N)
Alcohol Use
Time frame: 6 months
Had at least one alcoholic drink in past 30 days (Y/N)
Alcohol Use
Time frame: 12 months
Had at least one alcoholic drink in past 30 days (Y/N)
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40766111Reed 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.
- Derived from this study: PubMed 38869930Reed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Kaufman, PhD principal investigator
University of Colorado, Denver
Michelle Sarche, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Native WYSE CHOICES in people with Alcohol Exposed Pregnancy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376346, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.