Trial Outcomes & Findings for Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study (NCT NCT03930342)
NCT ID: NCT03930342
Last Updated: 2025-04-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
404 participants
Primary outcome timeframe
Baseline, 3 months and 6 months post intervention
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
199
|
|
Overall Study
Three Month Follow-up
|
155
|
139
|
|
Overall Study
Six Month Follow-up
|
150
|
139
|
|
Overall Study
COMPLETED
|
135
|
122
|
|
Overall Study
NOT COMPLETED
|
70
|
77
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
70
|
77
|
Baseline Characteristics
Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
Baseline characteristics by cohort
| Measure |
Native CHOICES Intervention
n=205 Participants
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.
|
Wait-list Control Group
n=199 Participants
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.
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
205 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
31.8 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
205 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
197 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
385 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
202 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
394 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Risk for Alcohol Exposed Pregnancy
|
205 Participants
n=5 Participants
|
199 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months and 6 months post interventionPopulation: Data was included only for participants who completed both the 3-month and 6-month follow-up visits.
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.
Outcome measures
| Measure |
Native CHOICES Intervention
n=135 Participants
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.
|
Wait-list Control Group
n=122 Participants
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.
|
|---|---|---|
|
Risk of Alcohol Exposed Pregnancy
|
103 Participants
|
99 Participants
|
Adverse Events
Native CHOICES Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 6 deaths
Wait-list Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Native CHOICES Intervention
n=207 participants at risk
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.
|
Wait-list Control Group
n=201 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Heart Attack
|
0.48%
1/207 • Number of events 1 • 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.
|
0.00%
0/201 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place