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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Sanford Research | OTHER |
| Missouri Breaks Industries Research, Inc. | OTHER |
| University of Minnesota |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael McDonell, MD | Washington State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri Breaks Industries Research Inc | Eagle Butte | South Dakota | 57625 | United States | ||
| Missouri Breaks Industries Research Inc |
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| ID | Title | Description |
|---|---|---|
| FG000 | Native CHOICES Intervention | Native-CHOICES will comprise usual care plus 2 Motivational Interviewing (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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data was included only for participants who completed both the 3-month and 6-month follow-up visits. | Posted | Count of Participants | Participants | Baseline, 3 months and 6 months post intervention |
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Adverse event data was collected through each participant's 6-month participation in the study.
Adverse events were largely made known through field staff's personal connection to the community.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Attack | Cardiac disorders | Non-systematic Assessment | At a follow up phone call visit the participant informed field staff that they were hospitalized with a heart attack. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael McDonell | Washington State University | 509 368-6967 | mmcdonell@wsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2024 | Mar 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2024 | Mar 4, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: In Person Version | Sep 12, 2023 | Mar 4, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Remote Version | Feb 23, 2023 | Mar 4, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
| D004327 | Drinking Behavior |
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| OTHER |
Women will be randomized 1:1 to the intervention or usual care conditions.
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| Rapid City |
| South Dakota |
| 57701 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Risk for Alcohol Exposed Pregnancy | Baseline enrollment criteria required participants to be at risk for an Alcohol Exposed Pregnancy (AEP) via risky drinking behaviors and engaging in sexual activity without effective and consistent contraceptive measures in the past 3 months. | Count of Participants | Participants |
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| OG001 | 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. |
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| 6 |
| 207 |
| 1 |
| 207 |
| 0 |
| 207 |
| EG001 | 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. | 2 | 201 | 0 | 201 | 0 | 201 |
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