Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
Phase: NA
Conditions: Contraceptive Usage, Alcohol Use Complicating Childbirth, Alcohol Drinking
Sponsor: Washington State University

 
 
 
 
 
 
 
Study Protocol 
 
Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study 
NCT03930342 
 
Document Date: 12/22/2024 
 
 

 
Ethics and community engagement 
The study protocol was approved by the Institutional Review Board of Washington State University, 
the tribe involved in this study, and the regional Indian Health Service Institutional Review Board. All 
participants completed informed consent prior to enrolling in the study. The tribe is not identiﬁed to 
ensure anonymity. Members of the Data Safety Monitoring Board regularly provided 
recommendations. The study also had an active Community Action Board, which included local 
elders, community leaders and Indian Health Service providers who advised and assisted the 
study. 
Sample size, setting, and recruitment 
In calculating the study power and sample size, we assumed approximately 15% attrition over 
follow-up. Based on a type-1 error rate of 5% and a risk of AEP of 70% in the control arm of the trial, 
we had 80% power to detect a 16% difference in the outcome probability between the two arms if 
350 women were enrolled. This difference is consistent with an approximately 30% to 80% 
reduction in AEP risk among intervention participants in a previous study (Hanson et al., 2017). 
Recruitment occurred from April 2019 to April 2023, stopping once the grant funding neared its end 
while also considering the time needed for follow-up data collection. Participants were recruited at 
a reservation site and an urban site with a relatively large AI/AN population. Participants were 
recruited through advertisements on social media and local newspaper and radio announcements. 
Recruitment also occurred in community settings, including women, infants, and children program 
offices, health fairs, powwows, the local community college, and word of mouth. Prior to the 
COVID-19 pandemic, the study's community-based staff set up booths or used dedicated areas in 
such facilities to display recruitment materials and describe the study's goals, risks, beneﬁts, and 
eligibility requirements. 
Eligibility 
Interested women completed an eligibility questionnaire; all enrollment, randomization, and data 
collection, including eligibility, was led by the study's community-based staff. Eligibility criteria 
were age between 18 and 44; self-identiﬁcation as AI/AN; living in one of eight counties that 
encompass both the reservation and urban site; and not residing in a household with someone 
already enrolled in the trial. Other criteria required an ability to get pregnant (not diagnosed as 
infertile); being sexually active with a male partner in the past 3 months; currently not using 
effective contraception deﬁned by standard methods (Centers for Disease Control and 
Prevention, 2023); and either heavy (eight or more standard drinks in a week) or binge drinking (four 
or more standard drinks in a single day) in the past 3 months. 
Intervention and control group 
After establishing eligibility, participants completed baseline data collection within approximately 
1 week, either in-person (pre-COVID-19 pandemic) or by telephone or video call (during the COVID-
19 pandemic). Participants were then randomized 1:1 to the Native CHOICES intervention or the 
waitlist control condition. Randomization occurred through a randomization card process using 

sealed sequentially numbered envelopes. The control group completed the six-week, three-month, 
and six-month interview with no other study interactions. After 6 months, individuals in the control 
group were given the opportunity to enroll in Native CHOICES. 
Native CHOICES 
The intent of the intervention was to reduce risk for AEP by decreasing or eliminating risky drinking 
among women who could become pregnant but were not, preventing unintended pregnancies 
through effective contraceptive use among risky drinkers, or both. The Native CHOICES 
intervention consisted of two MI sessions delivered over 4–6 weeks, with an elective contraception 
counseling session at a local clinic. These MI sessions included education on FASD; discussing 
drink size based on the type of alcohol consumed; and reviewing information on using effective 
contraception. Activities included a decisional balance exercise (e.g., “good” and “not so good 
things” about current alcohol and contraception behaviors); readiness rulers to assess how ready 
and sure participants were to change behaviors; and temptation/conﬁdence exercises to determine 
certain situations that might put participants more at risk for risky drinking and unintended 
pregnancies. Goal setting and reviewing goals were completed at the end of both sessions. As with 
previous CHOICES interventions, all aspects of the intervention were optional but focused on 
increasing participants' commitment to change using MI, which is a client-centered counseling 
approach intended to minimize resistance to change. Although both behaviors leading to risk for 
AEP were targeted, Native CHOICES interventionists could emphasize the behavior a participant 
chose to focus on in alignment with guidance provided in the original CHOICES protocol (Floyd 
et al., 2007). 
Native CHOICES was facilitated by a trained interventionist, who was a tribal member trained on 
the intervention and principles of MI. This training was facilitated by the ﬁrst author, who was 
trained by the original creators of the CHOICES intervention and has worked in this ﬁeld for 
20 years. Trainings were held in-person and virtually over the course of approximately 3 months, 
where interventionists learned about FASD, AEP, and Native CHOICES prior to completing 
education and activities related to MI. The interventionists practiced their MI skills with coworkers 
and reported back on their experiences during weekly 1-hour staff debrieﬁng sessions. 
Measures 
Baseline and follow-up data were collected at 6 weeks, 3 months, and 6 months postbaseline 
either in-person or by telephone or video call determined in part by policies during the pandemic. 
Data collection was conducted in-person (when COVID-19 conditions permitted) at baseline and 
6 months postbaseline, and by telephone or video call at 6 weeks and 3 months postbaseline or 
when in-person data collection was not possible. All participants were compensated $30 for 
completing questionnaires at baseline and at six months and $20 for completing data collection at 
6 weeks and 3 months. To retain participants, telephone and text reminders were made 2 weeks, 
1 week, and 1 day before each scheduled follow-up visit. 
At baseline, in addition to self-reported eligibility items, participants were asked about their 
education, household income, marital status, current residence, and current smoking status. 
Depression was assessed using the Center for Epidemiological Studies Depression Scale, 10-item 
version (CES-D-10) that asks respondents to rate how often over the past week they experienced 

symptoms associated with depression (Björgvinsson et al., 2013; Radloff, 1977). Scores range from 
0 to 30, with higher scores representing a more depressed mood. A score equal to or greater than 
10 on the CES-D-10 suggests depression. The Alcohol Use Disorders Identiﬁcation Test (AUDIT), a 
10-item screening tool that assesses alcohol consumption and alcohol-related problems, was 
used to identify potentially hazardous drinking patterns or active alcohol use disorders 
(Saunders, n.d.). Scores range from 0 to 40, where 0 indicates abstinence from alcohol and no 
previous alcohol issues; 1–7 suggests low-risk consumption; 8–14 suggests hazardous or harmful 
alcohol consumption; and 15 or more indicates the likelihood of alcohol dependence. Participants 
were also asked about current treatment for substance use or involvement in a support group or 12-
step meetings for substance use, activities that could inﬂuence risk of AEP. 
To evaluate AEP risk, we used questions about binge and heavy drinking adapted from the original 
CHOICES intervention (Floyd et al., 2007; Project CHOICES Research Group, 2003). Participants 
were asked about their alcohol consumption in the preceding 2 weeks: whether they had 
consumed four or more standard drinks on any single day (binge drinking), and if so, on how many 
days within that period, as well as whether they had consumed eight or more standard drinks within 
either of those weeks (heavy drinking). If respondents answered negatively for the previous 2 weeks, 
they were prompted to recall whether binge or heavy drinking had occurred over the last 3 months. 
Additionally, they were queried about their sexual activity over the preceding 3 months, along with 
the birth control methods used (e.g., hormonal contraceptives, IUDs, implants, or barrier 
methods). Women who reported not using any form of contraception during each sexual encounter 
were exempted from further contraception-related questions, while those who reported using at 
least one method were asked follow-up questions designed by the Centers for Disease Control and 
Prevention to assess the effectiveness of contraception use (Centers for Disease Control and 
Prevention, 2023). 
 
 

References  
Hanson, J.D., Nelson, M.E., Jensen, J.L., Willman, A., Jacobs-Knight, J. & Ingersoll, K. (2017) Impact 
of the CHOICES intervention in preventing alcohol-exposed pregnancies in American Indian 
women. Alcoholism?.Clinical.and.Experimental.Research, 41, 828–835. 
Centers For Disease Control And Prevention. (2023) Birth.control.methods. Available 
at: https://www.cdc.gov/reproductivehealth/contraception/index.htm [Accessed 14th 
September 2023]. 
Floyd, R.L., Sobell, M., Velasquez, M.M., Ingersoll, K., Nettleman, M., Sobell, L. et al. 
(2007) Preventing alcohol-exposed pregnancies: a randomized controlled trial. American.Journal.of.
Preventive.Medicine, 32, 1–10. 
Björgvinsson, T., Kertz, S.J., Bigda-Peyton, J.S., Mccoy, K.L. & Aderka, I.M. (2013) Psychometric 
properties of the CES-D-10 in a psychiatric sample. Assessment, 20, 429–436. 
Radloff, L.S. (1977) The CES-D scale:a self-report depression scale for research in the general 
population. Applied.Psychological.Measurement, 1, 385–401. 
Saunders, J.B. (n.d.) AUDIT.(Alcohol.Use.Disorders.Identiﬁcation.Test). Available 
at: https://auditscreen.org/ [Accessed 14th September 2023]. 
Project CHOICES Research Group. (2003) Reducing the risk of alcohol-exposed pregnancies: a 
study of a motivational intervention in community settings. Pediatrics, 111, 1131–1135.