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Behavioral Intervention

Mobile Health Intervention for Preventing Alcohol Exposed Pregnancy (WYSE CHOICES Trial)

N/A
Waitlist Available
Led By Carol Kaufman, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has an email account
Biologically female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

WYSE CHOICES Trial Summary

This trial will test a mobile health intervention to prevent AEPs among AIAN young women in urban settings. AEPs can cause FASDs, which are a leading cause of preventable birth defects in the US.

Who is the study for?
This trial is for non-pregnant, urban American Indian and Alaska Native young women aged 16-20 with a smartphone and email. They must not live on tribal lands or in small communities (under 50,000 people) and cannot be breastfeeding.Check my eligibility
What is being tested?
The study tests a mobile health intervention called Native WYSE CHOICES designed to prevent alcohol-exposed pregnancies among the target group by using social media recruitment methods.See study design
What are the potential side effects?
Since this is a behavioral intervention involving education and use of an app, there are no direct medical side effects; however, participants may experience stress or discomfort discussing sensitive topics.

WYSE CHOICES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an email account.
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I am biologically female.
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I am between 16 and 20 years old.

WYSE CHOICES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol Use
Effective Contraceptive Use

WYSE CHOICES Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
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.
Group II: Control ArmActive Control1 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.

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Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,237 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
791 Previous Clinical Trials
1,356,545 Total Patients Enrolled
1 Trials studying Alcohol Exposed Pregnancy
232 Patients Enrolled for Alcohol Exposed Pregnancy
Carol Kaufman, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

Media Library

Native WYSE CHOICES (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04376346 — N/A
Alcohol Exposed Pregnancy Clinical Trial 2023: Native WYSE CHOICES Highlights & Side Effects. Trial Name: NCT04376346 — N/A
Alcohol Exposed Pregnancy Research Study Groups: Control Arm, Intervention Arm
Native WYSE CHOICES (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04376346 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a way for me to partake in this scientific investigation?

"This clinical trial requires 700 female minors between 16 to 20 years old that have experienced alcohol exposure during pregnancy. Furthermore, those interested should identify as American Indian or Alaskan Native (AIAN), live outside of a tribal reservation and in an urban area with at least 50,000 inhabitants, not be pregnant nor breastfeeding currently and possess both a smart phone and email account."

Answered by AI

Does this research endeavor have any open enrollment opportunities?

"Affirmative, the records on clinicaltrials.gov indicate that this research is actively looking for volunteers to participate in their study. This trial was initially posted on August 4th 2021 and was recently modified on November 3rd 2022. 700 patients are expected to be enrolled at a single site of enrollment."

Answered by AI

What is the highest participant capacity of this research endeavor?

"Correct. Information hosted on clinicaltrials.gov exhibits that this medical trial, which was released on August 4th 2021, is still recruiting. In total, 700 individuals need to be enrolled from a single research site for the study to reach its desired sample size."

Answered by AI

Is the age threshold of this experiment confined to those over 55 or are younger individuals eligible as well?

"The desired cohort for this trial are individuals between the ages of sixteen and twenty."

Answered by AI
~123 spots leftby Mar 2025