Alcohol Drinking, Alcohol Use Complicating Childbirth, Contraceptive Usage
Conditions
Brief summary
Native CHOICES is a randomized controlled trial of an adapted intervention to reduce the risk of alcohol exposed pregnancies in American Indians and Alaska Natives (AI/ANs). We will enroll 350 AI/AN women living on the Cheyenne River Sioux Indian Reservation or in Rapid City in South Dakota who are 18-44 years old, have risky drinking behaviors, are not currently pregnant but are able to become pregnant, and are sexually active but not using effective contraception.
Detailed description
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 or in Rapid City in South Dakota who are 18-44 years old, have risky drinking behaviors, are not currently pregnant but are able to become 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.
Interventions
BEHAVIORALNative-CHOICES
Native CHOICES is a behavioral intervention for prevention of prenatal alcohol exposure in women at high risk for alcohol-exposed pregnancies. The intervention uses motivational interviewing and cognitive-behavioral strategies, and targets adoption of effective contraception and reduction of alcohol use.
Sponsors
University of Colorado, Denver
Sanford Research
Missouri Breaks Industries Research, Inc.
University of Minnesota
Washington State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Women will be randomized 1:1 to the intervention or usual care conditions.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Native American Woman * 18-44 years old at the time of recruitment * Self-report high-risk drinking behavior (average 8 or more drinks per week) or episodes of binge drinking (four or more drinks on a single occasion) in the past 90 days * Have vaginal sex with a male partner in the past 30 days
Exclusion criteria
* Diagnosed as infertile * Pregnant * Effectively using contraceptives defined by standard methods * Living in a household with someone who is already enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of Alcohol Exposed Pregnancy | Baseline, 3 months and 6 months post intervention | Our primary outcome is measurement of change in risk of alcohol exposed pregnancy (AEP). Being at risk for an AEP is defined as engaging in heavy/binge drinking and ineffective contraception use in the 3 months prior to the final data collection session after exposure to the intervention. Count reflects number of participants who remained at risk for an AEP. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Native CHOICES Intervention Native-CHOICES will comprise usual care plus 2 MI sessions delivered over 4 weeks; a contraception counseling session at a local clinic; and 3 months of electronic messaging to boost the effects of MI and counseling by increasing perceptions of social connection and social support for behavior change. Contraception counseling will be completed within 2 weeks after the second MI session, so the maximum duration of MI and counseling for each participant will be 6 weeks. Electronic messaging will include positive motivational content consistent with alcohol and contraception use goals set in the MI sessions.
Native-CHOICES: Native CHOICES is a behavioral intervention for prevention of prenatal alcohol exposure in women at high risk for alcohol-exposed pregnancies. The intervention uses motivational interviewing and cognitive-behavioral strategies, and targets adoption of effective contraception and reduction of alcohol use. | 205 |
| Wait-list Control Group The control condition will comprise usual care for the 6-month study period, with a wait-list design that offers women the Native- CHOICES program after they have completed the 6-month data collection. | 199 |
| Total | 404 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 70 | 77 |
Baseline characteristics
| Characteristic | Native CHOICES Intervention | Wait-list Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 205 Participants | 199 Participants | 404 Participants |
| Age, Continuous | 31.8 years STANDARD_DEVIATION 6.6 | 31.8 years STANDARD_DEVIATION 6.7 | 31.8 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 11 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 197 Participants | 188 Participants | 385 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 202 Participants | 192 Participants | 394 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Risk for Alcohol Exposed Pregnancy | 205 Participants | 199 Participants | 404 Participants |
| Sex: Female, Male Female | 205 Participants | 199 Participants | 404 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 207 | 2 / 201 |
| other Total, other adverse events | 0 / 207 | 0 / 201 |
| serious Total, serious adverse events | 1 / 207 | 0 / 201 |
Outcome results
Primary
Risk of Alcohol Exposed Pregnancy
Our primary outcome is measurement of change in risk of alcohol exposed pregnancy (AEP). Being at risk for an AEP is defined as engaging in heavy/binge drinking and ineffective contraception use in the 3 months prior to the final data collection session after exposure to the intervention. Count reflects number of participants who remained at risk for an AEP.
Time frame: Baseline, 3 months and 6 months post intervention
Population: Data was included only for participants who completed both the 3-month and 6-month follow-up visits.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Native CHOICES Intervention | Risk of Alcohol Exposed Pregnancy | 103 Participants |
| Wait-list Control Group | Risk of Alcohol Exposed Pregnancy | 99 Participants |
Comparison: Results here reflect analysis of the relative risk for AEP that is a combination of risk from baseline to the 3 month timepoint and risk between the 3 month timepoint and 6 month timepoint. This reflects changes in AEP risk across the course of exposure to the intervention (baseline to 3 month) and enduring change post-exposure (3 months to 6 months)95% CI: [0.83, 1.07]Regression, Logistic