NCT Number: NCT02337361
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.
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Notify Me18 year–44 year
Female
Interventional
Not applicable
La Clinica Women Infants and Children Program Site, Oakland, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bilingual (English and Spanish) e-SBI with four key components:
Time frame: 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
Time frame: baseline, 3 month, 6 month
weekly alcohol use is defined as at least drinking once a week or more often
Time frame: 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
Time frame: 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
Time frame: baseline, 3 months, 6 months
Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages
Time frame: 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.
Time frame: 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
Public Health Institute, California
Other
Preparing a Computerized Tool for Preventing Prenatal Drinking for a Larger Trial
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