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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA025603 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Native WYSE CHOICES | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use | Had at least one alcoholic drink in past 30 days (Y/N) | Baseline |
| Alcohol Use | Had at least one alcoholic drink in past 30 days (Y/N) | 1 month |
| Alcohol Use | Had at least one alcoholic drink in past 30 days (Y/N) | 6 months |
| Alcohol Use | Had at least one alcoholic drink in past 30 days (Y/N) | 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. | 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. | 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. | 6 months |
| Effective Contraceptive Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Kaufman, PhD | University of Colorado, Denver | Principal Investigator |
| Michelle Sarche, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado- Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40766111 | Derived | 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. | |
| 38869930 | Derived | Reed 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. |
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All eligible participants who signed an informed consent completed a baseline survey (online). Once the survey was complete, participants downloaded a mobile app. Upon opening the app they were randomly assigned to either the intervention or control arm, both available within the same app.
All participants enrolled at baseline are invited to participate in each follow-up survey, regardless of participation status of a previous follow-up survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 Month Follow up |
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| 6 Month Follow up |
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| 12 Month Follow up |
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Participants could not answer any question (per our IRB requirement). Thus, not all participants answered all questions on the baseline survey. Also, all baseline participants were invited to completed a follow-up survey at 1 month; they were also invited to complete surveys at 6, and 12 month follow up periods regardless of whether they completed the prior follow-up survey or not. Thus, some counts across arms will not match the original numbers randomized to each arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Population was defined as those age 16-20 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Use | Had at least one alcoholic drink in past 30 days (Y/N) | Participants could choose not to answer any question on this online survey | Posted | Count of Participants | Participants | Baseline |
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from enrollment to final follow-up (12 months)
Because this was a virtual, national study (virtually no in-person contact), we assessed events by survey data only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol Kaufman | Centers for American Indian and Alaska Native Health, University of Colorado Anschutz Medical Campus | 303-880-7795 | carol.kaufman@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2021 | Jul 31, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 17, 2021 | Jul 31, 2025 | ICF_001.pdf |
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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 |
| NOT COMPLETED |
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| NOT COMPLETED |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| year |
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| Sex/Gender, Customized | Population was defined as females only | Participants could choose not to answer any question on this online survey | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Race/ethnicity was designed as a "select all that apply"; participants had to select American Indian/Alaska Native as a race to be eligible | Participants could choose not to answer any question on this online survey | Count of Participants | Participants |
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|
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| Primary | Alcohol Use | Had at least one alcoholic drink in past 30 days (Y/N) | Participants could skip any question on the online survey; we also had attrition at follow-up | Posted | Count of Participants | Participants | 1 month |
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| Primary | Alcohol Use | Had at least one alcoholic drink in past 30 days (Y/N) | Participants could skip any question on the online survey; we also had attrition at follow-up | Posted | Count of Participants | Participants | 6 months |
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| Primary | Alcohol Use | Had at least one alcoholic drink in past 30 days (Y/N) | Participants could skip any question on the online survey; we also had attrition at follow-up | Posted | Count of Participants | Participants | 12 months |
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| 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. | Participants could skip any question on the online survey. | Posted | Count of Participants | Participants | Baseline |
|
|
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| 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. | Participants could skip any question on the online survey; we also had attrition at follow-up. | Posted | Count of Participants | Participants | 1 months |
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| 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. | Participants could skip any question on the online survey; we also had attrition at follow-up. | Posted | Count of Participants | Participants | 6 months |
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| 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. | Participants could skip any question on the online survey; we also had attrition at follow-up. | Posted | Count of Participants | Participants | 12 months |
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| 0 |
| 218 |
| 0 |
| 218 |
| 0 |
| 218 |
| EG001 | 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. | 0 | 221 | 0 | 221 | 0 | 221 |
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