Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study

NCT03930342 | Completed Results DMC

• 1 other identifier: 17162-001
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 2

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.

Conditions

Contraceptive Usage; Alcohol Use Complicating Childbirth; Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months and 6 months post intervention

Study Arms (2)

Native CHOICES Intervention

EXPERIMENTAL

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.

Behavioral: Native-CHOICES

Wait-list Control Group

NO INTERVENTION

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.

Interventions

Native-CHOICES BEHAVIORAL

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.

Native CHOICES Intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Native American Woman
• 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

You may not qualify if:

• Diagnosed as infertile
• Pregnant
• Effectively using contraceptives defined by standard methods
• Living in a household with someone who is already enrolled in the study

Sponsors & Collaborators

• Washington State University: lead
• University of Colorado, Denver: collaborator
• Sanford Research: collaborator
• Missouri Breaks Industries Research, Inc.: collaborator
• University of Minnesota: collaborator

Study Sites (2)

Missouri Breaks Industries Research Inc

Eagle Butte, South Dakota, 57625, United States

Location

Missouri Breaks Industries Research Inc

Rapid City, South Dakota, 57701, United States

Location

MeSH Terms

Conditions

Contraception Behavior; Alcohol Drinking

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Drinking Behavior

Limitations and Caveats

The COVID pandemic hit mid-data collection and this meant that the intervention that was planned for exclusively in-person delivery had to be adapted for delivery over the telephone which may have impacted the results. This study was also regionally and culturally specific to AI communities in the Northern Plains.

Results Point of Contact

• Title: Michael McDonell
• Organization: Washington State University

mmcdonell@wsu.edu

509 368-6967

Study Officials

• Michael McDonell, MD

  Washington State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Women will be randomized 1:1 to the intervention or usual care conditions.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: March 28, 2019
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)