Randomized Trial of an Intervention for Preventing Alcohol Exposed Pregnancy among Women in a Remote Reservation Community

摘要研究项目1

ABSTRACT RESEARCH PROJECT 1 Fetal alcohol spectrum disorder (FASD) prevalence is up to 10 times higher in American Indians and Alaska Natives (AI/ANs) 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/ANs 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 6 months than women receiving usual care, but the trial did not enroll AI/ANs 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/ANs is unknown. We propose a randomized controlled trial of an adapted intervention – Native-CHOICES – to reduce risk of alcohol exposed pregnancies in AI/ANs. 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 2 motivational interviewing sessions plus 1 contraceptive counseling session over 4 weeks, with supportive electronic messaging for 3 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 6 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/ANs, and the first trial of CHOICES for rural women of any race. Testing in rural AI/ANs 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.