Native Center for Alcohol Research and Education (NCARE) Research Project 1 (RP1): Randomized Trial of an Intervention for Preventing Alcohol Exposed Pregnancy among Women in a Remote Reservation Community (Native-CHOICES)

Status: Current

Grant Start: 12/15/2017

Grant End: 11/30/2022

Fetal alcohol spectrum disorder (FASD) prevalence is up to 10 times higher in American Indian and Alaska Native (AI/AN) people than in the general US population, yet FASD is 100% preventable. Even moderate alcohol use during pregnancy can affect fetal growth and behavioral outcomes. Alcohol use disorders and binge drinking in women are among the strongest risk factors for FASD in their offspring. AI/AN people have the highest prevalence of alcohol use disorders among US racial and ethnic groups, and are the most likely to engage in binge drinking during pregnancy. A growing consensus indicates that prevention of alcohol-exposed pregnancy must begin before conception. One promising approach is the Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study (CHOICES), which combines motivational interviewing with contraception counseling for non-pregnant women. In a randomized trial, women receiving CHOICES were 36% more likely to have reduced risk for alcohol-exposed pregnancies after six months than women receiving usual care, but the trial did not enroll AI/AN or rural women. Although the Centers for Disease Control and Prevention has recommended its dissemination, the public health value and cost-effectiveness of CHOICES in AI/AN people is unknown. We propose a randomized controlled trial of an adapted intervention – Native-CHOICES – to reduce risk of alcohol exposed pregnancies in AI/AN people. We will enroll 350 AI/AN women living on the Cheyenne River Sioux Indian Reservation in South Dakota who are 18-44 years old, have prevalent alcohol use disorders or other risky drinking behaviors, are not currently pregnant, and are sexually active but not using effective contraception. Native-CHOICES will consist of two motivational interviewing sessions plus one contraceptive counseling session over four weeks, with supportive electronic messaging for three months to increase perceived social connectedness and support for modifying drinking behavior and using contraception. It uses a wait-list control design in which participants will be randomized to receive either usual care plus Native-CHOICES (intervention) or usual care only (control). Our Specific Aims are to: 1) Test the effectiveness of Native-CHOICES vs. usual care for reducing alcohol-exposed pregnancy risk (less risky drinking, effective contraception, or both) over six months; 2) Use surveys and interviews to evaluate Native-CHOICES’ reach, acceptability, and sustainability; and 3) Conduct cost-benefit and cost- effectiveness analyses for a comprehensive economic evaluation of Native-CHOICES vs. usual care. FASD treatment is expensive and prevention is critical to reducing this tragic and avoidable public health problem. Ours will be the first randomized controlled trial to prevent alcohol-exposed pregnancies in AI/AN women, and the first trial of CHOICES for rural women of any race. Testing in rural AI/AN women is important because this population faces unique barriers to accessing healthcare, and may have different normative views on alcohol use during pregnancy compared to other communities in which CHOICES has previously been tested.

Partners

  • Missouri Breaks Industries Research Inc.
  • University of Colorado - Denver
  • Cheyenne River Sioux Tribe
  • Sanford Research

Funding Sponsors

  • National Institutes of Health (NIH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Communities Involved

  • Tribal communities
  • Rural communities

Study Locations

  • South Dakota

Study Type

  • Intervention
  • Community based participatory research
  • Motivational interviewing

Study Characteristics

  • Ages 18 plus

IREACH Programs

Team Member(s)

Heath Research Initiatives

  • American Indian and Alaska Native Health
  • Rural Health

Focus Areas

  • Alcohol use
  • Behavioral health
  • Community-based participatory research