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

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ClinicalTrials.gov Identifier: NCT04376346
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Exposed Pregnancy Behavioral: Native WYSE CHOICES Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES
Estimated Study Start Date : April 14, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Arm Intervention/treatment
Experimental: Intervention Arm
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.
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.

No Intervention: Control Arm
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.



Primary Outcome Measures :
  1. Alcohol Use [ Time Frame: Baseline ]
    Number of days in past 30 had at least one alcoholic drink.

  2. Alcohol Use [ Time Frame: 2 months ]
    Number of days in past 30 had at least one alcoholic drink.

  3. Alcohol Use [ Time Frame: 6 months ]
    Number of days in past 30 had at least one alcoholic drink.

  4. Alcohol Use [ Time Frame: 12 months ]
    Number of days in past 30 had at least one alcoholic drink.

  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: 2 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.



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Ages Eligible for Study:   16 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Indian or Alaska Native (AIAN)
  • 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

Exclusion Criteria:

  • Men
  • Non AIAN women
  • Pregnant women
  • Non-English speakers
  • People who live on a tribal land and communities with less than 50,000 in population

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376346


Contacts
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Contact: Umit Shrestha, PhD 3037241463 umit.shrestha@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado- Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Umit Shrestha, PhD    303-724-1463    umit.shrestha@cuanschutz.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Carol Kaufman, PhD University of Colorado - Anschutz Medical Campus
Principal Investigator: Michelle Sarche, PhD University of Colorado - Anschutz Medical Campus
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04376346    
Other Study ID Numbers: 18-0574
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No