Foetal Exposure During Pregnancy
Conditions
Keywords
risky alcohol use, pregnancy
Brief summary
An innovative, self-administered computerized screening and brief intervention (SBI) for drinking during pregnancy will be adapted for use with non-pregnant childbearing age women and its efficacy will be tested in a small trial. Study findings will inform a larger randomized control trial for a primary prevention tool with the potential for broad health impact.
Detailed description
This study evaluates a recently piloted, self-administered, computerized tool for reducing prenatal drinking that added novel components of drink size assessment and drink size feedback to traditional screening and brief intervention (SBI). The bilingual (English and Spanish) electronic SBI or e-SBI will be adapted for use with non-pregnant women and a small trial of its efficacy will be conducted in two public health clinics. The effects of drink size assessment by itself and of depression as a modifier of e-SBI efficacy will also be studied. Study findings will help design a larger trial of e-SBI's efficacy for reducing prenatal alcohol use. An experimental design will be used for the proposed small trial. Two hundred women, who have not been pregnant in the past year and report alcohol at risky levels will be randomly assigned to e-SBI or usual care. Participants will complete baseline, 3-month and 6-month follow-up assessments. These assessments will examine drinking and pregnancy as well as possible negative outcomes, such as increased drug use associated with the e-SBI. To address methodological limitations in prior research, the study design incorporates drink size assessment to better measure drinking outcomes, minimizes assessment reactivity for controls at baseline, and includes a booster e-SBI at the 3-month follow up. This allows for the examination of whether drink size assessment reduces drinking by itself and if its effects are equivalent to that of the full e-SBI. With these design innovations, the study is expected to provide information that can be more rigorously assessed in a subsequent multi-arm trial. Because it sets the stage for a Phase II trial of e-SBI efficacy for reducing prenatal alcohol use, our proposed study is of significance for improved maternal and child health. Findings will also impact the larger intervention literature on cost-effective strategies to reduce alcohol-related harm.
Interventions
BEHAVIORALElectronic 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.
Sponsors
La Clínica de La Raza Inc.
Sonoma County Department of Health Services
Public Health Institute, California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* not pregnant in the last 6 months, drank alcohol in the past year, alcohol consumption was at risky levels,
Exclusion criteria
* not fluent in english or spanish,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Risky Alcohol Use | baseline, 3 months, 6 months | 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 |
| Number of Participants Reporting Weekly Alcohol Use | baseline, 3 month, 6 month | weekly alcohol use is defined as at least drinking once a week or more often |
| Number of Participants Reporting Heavy Alcohol Use | baseline, 3 month, 6 month | heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Any Tobacco Use | baseline , 3 months, 6 months | Any Tobacco use is measured as any use in the past 3 months of any smoking or chewing tobacco, including cigarettes |
| Number of Participants Reporting Any Drug Use | baseline, 3 month, 6 month | Any drug use is defined as use of any substances, e.g., marijuana, stimulants, etc other than tobacco, in the past 3 months |
| Number of Participants Reporting Frequent Sugar Sweetened Beverage Use | baseline, 3 months, 6 months | Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages |
| Number of Participants Reporting Significant Depression | baseline, 3 months, 6 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
Participant was assigned to control group but did not complete baseline assessment
Participants by arm
| Arm | Count |
|---|---|
| e-SBI 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. | 99 |
| Control Treatment as usual with only assessment | 86 |
| Total | 185 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3-month Follow-up | Lost to Follow-up | 19 | 14 |
| 6-month Follow-up | Lost to Follow-up | 2 | 4 |
Baseline characteristics
| Characteristic | e-SBI | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 99 Participants | 86 Participants | 185 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 72 Participants | 66 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 20 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 99 participants | 86 participants | 185 participants |
| Risky alcohol use | 99 Participants | 86 Participants | 185 Participants |
| Sex: Female, Male Female | 99 Participants | 86 Participants | 185 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 86 |
| other Total, other adverse events | 0 / 99 | 0 / 86 |
| serious Total, serious adverse events | 0 / 99 | 0 / 86 |
Outcome results
Primary
Number of Participants Reporting Heavy Alcohol Use
heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks
Time frame: baseline, 3 month, 6 month
Population: Numbers at 3 and 6 month reflect participant attrition
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| e-SBI | Number of Participants Reporting Heavy Alcohol Use | Baseline | 19 Participants |
| e-SBI | Number of Participants Reporting Heavy Alcohol Use | 3 month | 14 Participants |
| e-SBI | Number of Participants Reporting Heavy Alcohol Use | 6 month | 7 Participants |
| Control | Number of Participants Reporting Heavy Alcohol Use | Baseline | 16 Participants |
| Control | Number of Participants Reporting Heavy Alcohol Use | 3 month | 18 Participants |
| Control | Number of Participants Reporting Heavy Alcohol Use | 6 month | 16 Participants |
p-value: <0.05t-test, 2 sided
Primary
Number of Participants Reporting Risky Alcohol Use
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
Time frame: baseline, 3 months, 6 months
Population: 3 and 6 month numbers for each arm (study condition) reflect participant attrition over time
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| e-SBI | Number of Participants Reporting Risky Alcohol Use | baseline | 99 Participants |
| e-SBI | Number of Participants Reporting Risky Alcohol Use | 3 month | 60 Participants |
| e-SBI | Number of Participants Reporting Risky Alcohol Use | 6 month | 45 Participants |
| Control | Number of Participants Reporting Risky Alcohol Use | baseline | 86 Participants |
| Control | Number of Participants Reporting Risky Alcohol Use | 3 month | 48 Participants |
| Control | Number of Participants Reporting Risky Alcohol Use | 6 month | 41 Participants |
Primary
Number of Participants Reporting Weekly Alcohol Use
weekly alcohol use is defined as at least drinking once a week or more often
Time frame: baseline, 3 month, 6 month
Population: 3 and 6 month numbers for each arm (study condition) reflect participant attrition over time
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| e-SBI | Number of Participants Reporting Weekly Alcohol Use | Baseline | 22 Participants |
| e-SBI | Number of Participants Reporting Weekly Alcohol Use | 3 month | 17 Participants |
| e-SBI | Number of Participants Reporting Weekly Alcohol Use | 6 month | 9 Participants |
| Control | Number of Participants Reporting Weekly Alcohol Use | Baseline | 14 Participants |
| Control | Number of Participants Reporting Weekly Alcohol Use | 3 month | 16 Participants |
| Control | Number of Participants Reporting Weekly Alcohol Use | 6 month | 16 Participants |
p-value: <0.01t-test, 2 sided
Secondary
Number of Participants Reporting Any Drug Use
Any drug use is defined as use of any substances, e.g., marijuana, stimulants, etc other than tobacco, in the past 3 months
Time frame: baseline, 3 month, 6 month
Population: numbers at 3 and 6 month reflect participant attrition over time
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| e-SBI | Number of Participants Reporting Any Drug Use | 6 month | 9 Participants |
| e-SBI | Number of Participants Reporting Any Drug Use | Baseline | 12 Participants |
| e-SBI | Number of Participants Reporting Any Drug Use | 3 month | 8 Participants |
| Control | Number of Participants Reporting Any Drug Use | 3 month | 6 Participants |
| Control | Number of Participants Reporting Any Drug Use | Baseline | 10 Participants |
| Control | Number of Participants Reporting Any Drug Use | 6 month | 5 Participants |
Secondary
Number of Participants Reporting Any Tobacco Use
Any Tobacco use is measured as any use in the past 3 months of any smoking or chewing tobacco, including cigarettes
Time frame: baseline , 3 months, 6 months
Population: numbers at follow up reflect participant attrition over time
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| e-SBI | Number of Participants Reporting Any Tobacco Use | Baseline | 20 Participants |
| e-SBI | Number of Participants Reporting Any Tobacco Use | 3 month | 12 Participants |
| e-SBI | Number of Participants Reporting Any Tobacco Use | 6 month | 9 Participants |
| Control | Number of Participants Reporting Any Tobacco Use | 6 month | 13 Participants |
| Control | Number of Participants Reporting Any Tobacco Use | Baseline | 16 Participants |
| Control | Number of Participants Reporting Any Tobacco Use | 3 month | 11 Participants |
p-value: <0.1t-test, 2 sided
Secondary
Number of Participants Reporting Frequent Sugar Sweetened Beverage Use
Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages
Time frame: baseline, 3 months, 6 months
Population: numbers at 3 and 6 month reflect participant attrition over time
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| e-SBI | Number of Participants Reporting Frequent Sugar Sweetened Beverage Use | Baseline | 65 Participants |
| e-SBI | Number of Participants Reporting Frequent Sugar Sweetened Beverage Use | 3 month | 55 Participants |
| e-SBI | Number of Participants Reporting Frequent Sugar Sweetened Beverage Use | 6 month | 41 Participants |
| Control | Number of Participants Reporting Frequent Sugar Sweetened Beverage Use | Baseline | 58 Participants |
| Control | Number of Participants Reporting Frequent Sugar Sweetened Beverage Use | 3 month | 46 Participants |
| Control | Number of Participants Reporting Frequent Sugar Sweetened Beverage Use | 6 month | 33 Participants |
p-value: <0.01t-test, 2 sided
Secondary
Number of Participants Reporting Significant Depression
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.
Time frame: baseline, 3 months, 6 months
Population: numbers at 3 and 6 month reflect participant attrition over time
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| e-SBI | Number of Participants Reporting Significant Depression | Baseline | 22 Participants |
| e-SBI | Number of Participants Reporting Significant Depression | 3 month | 16 Participants |
| e-SBI | Number of Participants Reporting Significant Depression | 6 month | 8 Participants |
| Control | Number of Participants Reporting Significant Depression | Baseline | 11 Participants |
| Control | Number of Participants Reporting Significant Depression | 3 month | 12 Participants |
| Control | Number of Participants Reporting Significant Depression | 6 month | 11 Participants |