Trial Outcomes & Findings for Computerized Tool for Preventing Prenatal Drinking (NCT NCT02337361)
NCT ID: NCT02337361
Last Updated: 2019-01-25
Results Overview
Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day. Risky alcohol use is measured by frequency of any alcohol use, number of usual and maximum drinks in a drinking day, and frequency of drinking 3 or more drinks containing alcohol
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
185 participants
Primary outcome timeframe
baseline, 3 months, 6 months
Results posted on
2019-01-25
Participant Flow
Participant was assigned to control group but did not complete baseline assessment
Participant milestones
| Measure |
e-SBI
Single session, Electronic Screening and Brief Intervention (SBI) for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
Treatment as usual with only assessment
|
|---|---|---|
|
Baseline Assessment
STARTED
|
99
|
86
|
|
Baseline Assessment
COMPLETED
|
99
|
86
|
|
Baseline Assessment
NOT COMPLETED
|
0
|
0
|
|
3-month Follow-up
STARTED
|
99
|
86
|
|
3-month Follow-up
COMPLETED
|
80
|
72
|
|
3-month Follow-up
NOT COMPLETED
|
19
|
14
|
|
6-month Follow-up
STARTED
|
80
|
72
|
|
6-month Follow-up
COMPLETED
|
78
|
68
|
|
6-month Follow-up
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
e-SBI
Single session, Electronic Screening and Brief Intervention (SBI) for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
Treatment as usual with only assessment
|
|---|---|---|
|
3-month Follow-up
Lost to Follow-up
|
19
|
14
|
|
6-month Follow-up
Lost to Follow-up
|
2
|
4
|
Baseline Characteristics
Computerized Tool for Preventing Prenatal Drinking
Baseline characteristics by cohort
| Measure |
e-SBI
n=99 Participants
Single session, Electronic SBI for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
n=86 Participants
Treatment as usual with only assessment
|
Total
n=185 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
|
99 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
185 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
|
72 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
47 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
|
|
Region of Enrollment
United States
|
99 participants
n=5 Participants
|
86 participants
n=7 Participants
|
185 participants
n=5 Participants
|
|
Risky alcohol use
|
99 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: 3 and 6 month numbers for each arm (study condition) reflect participant attrition over time
Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day. Risky alcohol use is measured by frequency of any alcohol use, number of usual and maximum drinks in a drinking day, and frequency of drinking 3 or more drinks containing alcohol
Outcome measures
| Measure |
e-SBI
n=99 Participants
Single session, Electronic SBI for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
n=86 Participants
Treatment as usual with only assessment
|
|---|---|---|
|
Number of Participants Reporting Risky Alcohol Use
baseline
|
99 Participants
|
86 Participants
|
|
Number of Participants Reporting Risky Alcohol Use
3 month
|
60 Participants
|
48 Participants
|
|
Number of Participants Reporting Risky Alcohol Use
6 month
|
45 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 month, 6 monthPopulation: 3 and 6 month numbers for each arm (study condition) reflect participant attrition over time
weekly alcohol use is defined as at least drinking once a week or more often
Outcome measures
| Measure |
e-SBI
n=99 Participants
Single session, Electronic SBI for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
n=86 Participants
Treatment as usual with only assessment
|
|---|---|---|
|
Number of Participants Reporting Weekly Alcohol Use
Baseline
|
22 Participants
|
14 Participants
|
|
Number of Participants Reporting Weekly Alcohol Use
3 month
|
17 Participants
|
16 Participants
|
|
Number of Participants Reporting Weekly Alcohol Use
6 month
|
9 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: baseline, 3 month, 6 monthPopulation: Numbers at 3 and 6 month reflect participant attrition
heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks
Outcome measures
| Measure |
e-SBI
n=99 Participants
Single session, Electronic SBI for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
n=86 Participants
Treatment as usual with only assessment
|
|---|---|---|
|
Number of Participants Reporting Heavy Alcohol Use
Baseline
|
19 Participants
|
16 Participants
|
|
Number of Participants Reporting Heavy Alcohol Use
3 month
|
14 Participants
|
18 Participants
|
|
Number of Participants Reporting Heavy Alcohol Use
6 month
|
7 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: baseline , 3 months, 6 monthsPopulation: numbers at follow up reflect participant attrition over time
Any Tobacco use is measured as any use in the past 3 months of any smoking or chewing tobacco, including cigarettes
Outcome measures
| Measure |
e-SBI
n=99 Participants
Single session, Electronic SBI for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
n=86 Participants
Treatment as usual with only assessment
|
|---|---|---|
|
Number of Participants Reporting Any Tobacco Use
Baseline
|
20 Participants
|
16 Participants
|
|
Number of Participants Reporting Any Tobacco Use
3 month
|
12 Participants
|
11 Participants
|
|
Number of Participants Reporting Any Tobacco Use
6 month
|
9 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: numbers at 3 and 6 month reflect participant attrition over time
Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages
Outcome measures
| Measure |
e-SBI
n=99 Participants
Single session, Electronic SBI for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
n=86 Participants
Treatment as usual with only assessment
|
|---|---|---|
|
Number of Participants Reporting Frequent Sugar Sweetened Beverage Use
3 month
|
55 Participants
|
46 Participants
|
|
Number of Participants Reporting Frequent Sugar Sweetened Beverage Use
Baseline
|
65 Participants
|
58 Participants
|
|
Number of Participants Reporting Frequent Sugar Sweetened Beverage Use
6 month
|
41 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 monthsPopulation: numbers at 3 and 6 month reflect participant attrition over time
Significant depression is measured as scoring above the cutoff of 6 on the total score on the 9 item Physician's health questionnaire (PHQ-9). The 9-item Patient Health Questionnaire (PHQ-9) is a self-report measure of depression symptoms in the past two weeks. Scores can range from 0 to 27, with a score of 6 or more indicating significant depression symptoms in samples of childbearing age women.
Outcome measures
| Measure |
e-SBI
n=99 Participants
Single session, Electronic SBI for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
n=86 Participants
Treatment as usual with only assessment
|
|---|---|---|
|
Number of Participants Reporting Significant Depression
Baseline
|
22 Participants
|
11 Participants
|
|
Number of Participants Reporting Significant Depression
3 month
|
16 Participants
|
12 Participants
|
|
Number of Participants Reporting Significant Depression
6 month
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: baseline, 3 month, 6 monthPopulation: numbers at 3 and 6 month reflect participant attrition over time
Any drug use is defined as use of any substances, e.g., marijuana, stimulants, etc other than tobacco, in the past 3 months
Outcome measures
| Measure |
e-SBI
n=99 Participants
Single session, Electronic SBI for risky alcohol use
Electronic SBI: Bilingual (English and Spanish) e-SBI with four key components:
1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.
|
Control
n=86 Participants
Treatment as usual with only assessment
|
|---|---|---|
|
Number of Participants Reporting Any Drug Use
6 month
|
9 Participants
|
5 Participants
|
|
Number of Participants Reporting Any Drug Use
Baseline
|
12 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Drug Use
3 month
|
8 Participants
|
6 Participants
|
Adverse Events
e-SBI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Madhabika B. Nayak
Public Health Institute/Alcohol Research Group
Phone: 510-898-5849
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place