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: Ended

Fetal alcohol spectrum disorder (FASD) is a serious but preventable spectrum of conditions. 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 racialized and ethnic groups, and binge drinking patterns tend to be high as well. 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.

In the Native CHOICES study we proposed enrolling 350 American Indian/Alaska Native women who were 18-44 years old, had prevalent Alcohol Use Disorders or other risky drinking behaviors, were not currently pregnant, and were sexually active but not using effective contraception. Native-CHOICES consisted of 2 brief Motivational Interviewing sessions plus optional 1 contraceptive counseling session over 4 weeks, with optional supportive electronic messaging (e.g., text messages or Facebook Messenger) for 3 months. The text messages were designed to increase perceived social connectedness and support for modifying drinking behavior and using contraception. We used a wait-list control design in which participants were randomized to receive either usual care plus Native-CHOICES (intervention) or usual care only with the option of receiving Native-CHOICES after completing the study (control). Our primary outcome was reduction in alcohol exposed pregnancy risk (reduced risky drinking, increased effective contraception use, or both) over 6 months, a timeframe commonly used in studies of alcohol exposed pregnancy prevention.

Our Specific Aims were 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.

The team overcame pandemic-related barriers to randomize 408 AI/AN women from a Northern Plains community. Prior to the pandemic, women who completed Native CHOICES had a 21% drop in the chance of having an alcohol exposed pregnancy. Unfortunately, because outcome analyses included all randomized participants (those before, during, and after the pandemic), the intervention had no group effect on alcohol exposed pregnancies. However, modest reductions in alcohol exposed pregnancy risk were associated with an overall economic benefit of $2,330 to $2,572 per quality-adjusted life year gained. Qualitative results indicate that women perceived that Native CHOICES taught them about sexual health, helped them set goals, and increased awareness of their alcohol use. They also felt the program was culturally acceptable.

IREACH Programs

• Native Center for Alcohol Research and Education

Team Member(s)

• Marcia O’Leary, RN
  Site Principal Investigator
• Michelle Sarche, PhD
  Co-Investigator
• Jessica Hanson, PhD
  Co-Investigator
• Kyra Oziel
  Senior Research Project Manager

Heath Research Initiatives

• American Indian and Alaska Native Health
• Rural Health

Focus Areas

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