Clinical trial NCT04376346: Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES
Official title: Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Exposed Pregnancy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-05-06
Enrollment: 439
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Alcohol Use
timeFrame: Baseline
measure: Alcohol Use
timeFrame: 2 months
measure: Alcohol Use
timeFrame: 6 months
measure: Alcohol Use
timeFrame: 12 months
measure: Effective Contraceptive Use
timeFrame: Baseline
measure: Effective Contraceptive Use
timeFrame: 2 months
measure: Effective Contraceptive Use
timeFrame: 6 months
measure: Effective Contraceptive Use
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado- Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Carol Kaufman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Michelle Sarche, PhD
role: PRINCIPAL_INVESTIGATOR
References: