Alcohol Exposed Pregnancy
Conditions
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.
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.
Interventions
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.
Sponsors
Study design
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use | Baseline | Had at least one alcoholic drink in past 30 days (Y/N) |
| Effective Contraceptive Use | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 218 |
| 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. | 221 |
| Total | 439 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 18.02 year STANDARD_DEVIATION 1.39 | 18.16 year STANDARD_DEVIATION 1.39 | 18.09 year STANDARD_DEVIATION 1.39 |
| Race/Ethnicity, Customized African American | 12 Participants | 18 Participants | 30 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 218 Participants | 221 Participants | 439 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 7 Participants | 16 Participants |
| Race/Ethnicity, Customized Hispanic/Latinx | 50 Participants | 66 Participants | 116 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized White/Caucasian | 66 Participants | 66 Participants | 132 Participants |
| Sex/Gender, Customized Female | 194 Participants | 190 Participants | 384 Participants |
| Sex/Gender, Customized Missing | 2 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Non-binary | 7 Participants | 17 Participants | 24 Participants |
| Sex/Gender, Customized Other/not sure | 3 Participants | 5 Participants | 8 Participants |
| Sex/Gender, Customized Trans male | 1 Participants | 1 Participants | 2 Participants |
| Sex/Gender, Customized two-spirit | 11 Participants | 8 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 218 | 0 / 221 |
| other Total, other adverse events | 0 / 218 | 0 / 221 |
| serious Total, serious adverse events | 0 / 218 | 0 / 221 |
Outcome results
Alcohol Use
Had at least one alcoholic drink in past 30 days (Y/N)
Time frame: 6 months
Population: Participants could skip any question on the online survey; we also had attrition at follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Alcohol Use | Yes | 56 Participants |
| Intervention Arm | Alcohol Use | No | 97 Participants |
| Intervention Arm | Alcohol Use | Missing | 65 Participants |
| Control Arm | Alcohol Use | Yes | 69 Participants |
| Control Arm | Alcohol Use | No | 86 Participants |
| Control Arm | Alcohol Use | Missing | 66 Participants |
Alcohol Use
Had at least one alcoholic drink in past 30 days (Y/N)
Time frame: 12 months
Population: Participants could skip any question on the online survey; we also had attrition at follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Alcohol Use | No | 84 Participants |
| Intervention Arm | Alcohol Use | Missing | 63 Participants |
| Intervention Arm | Alcohol Use | Yes | 71 Participants |
| Control Arm | Alcohol Use | No | 88 Participants |
| Control Arm | Alcohol Use | Missing | 59 Participants |
| Control Arm | Alcohol Use | Yes | 74 Participants |
Alcohol Use
Had at least one alcoholic drink in past 30 days (Y/N)
Time frame: 1 month
Population: Participants could skip any question on the online survey; we also had attrition at follow-up
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Alcohol Use | Yes | 59 Participants |
| Intervention Arm | Alcohol Use | No | 93 Participants |
| Intervention Arm | Alcohol Use | Missing | 66 Participants |
| Control Arm | Alcohol Use | Yes | 60 Participants |
| Control Arm | Alcohol Use | No | 94 Participants |
| Control Arm | Alcohol Use | Missing | 67 Participants |
Alcohol Use
Had at least one alcoholic drink in past 30 days (Y/N)
Time frame: Baseline
Population: Participants could choose not to answer any question on this online survey
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Alcohol Use | Yes | 86 Participants |
| Intervention Arm | Alcohol Use | No | 131 Participants |
| Intervention Arm | Alcohol Use | Missing | 1 Participants |
| Control Arm | Alcohol Use | Yes | 82 Participants |
| Control Arm | Alcohol Use | No | 137 Participants |
| Control Arm | Alcohol Use | Missing | 2 Participants |
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.
Time frame: Baseline
Population: Participants could skip any question on the online survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Effective Contraceptive Use | Yes | 209 Participants |
| Intervention Arm | Effective Contraceptive Use | Missing | 0 Participants |
| Intervention Arm | Effective Contraceptive Use | No | 9 Participants |
| Control Arm | Effective Contraceptive Use | Missing | 1 Participants |
| Control Arm | Effective Contraceptive Use | Yes | 197 Participants |
| Control Arm | Effective Contraceptive Use | No | 23 Participants |
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.
Time frame: 1 months
Population: Participants could skip any question on the online survey; we also had attrition at follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Effective Contraceptive Use | Yes | 145 Participants |
| Intervention Arm | Effective Contraceptive Use | No | 7 Participants |
| Intervention Arm | Effective Contraceptive Use | Missing | 66 Participants |
| Control Arm | Effective Contraceptive Use | Yes | 143 Participants |
| Control Arm | Effective Contraceptive Use | No | 13 Participants |
| Control Arm | Effective Contraceptive Use | Missing | 65 Participants |
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.
Time frame: 6 months
Population: Participants could skip any question on the online survey; we also had attrition at follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Effective Contraceptive Use | Yes | 144 Participants |
| Intervention Arm | Effective Contraceptive Use | No | 10 Participants |
| Intervention Arm | Effective Contraceptive Use | Missing | 64 Participants |
| Control Arm | Effective Contraceptive Use | Yes | 140 Participants |
| Control Arm | Effective Contraceptive Use | No | 15 Participants |
| Control Arm | Effective Contraceptive Use | Missing | 66 Participants |
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.
Time frame: 12 months
Population: Participants could skip any question on the online survey; we also had attrition at follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Effective Contraceptive Use | Yes | 146 Participants |
| Intervention Arm | Effective Contraceptive Use | No | 10 Participants |
| Intervention Arm | Effective Contraceptive Use | Missing | 62 Participants |
| Control Arm | Effective Contraceptive Use | Yes | 146 Participants |
| Control Arm | Effective Contraceptive Use | No | 18 Participants |
| Control Arm | Effective Contraceptive Use | Missing | 57 Participants |