Study Results
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View full resultsBasic Information
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COMPLETED
NA
185 participants
INTERVENTIONAL
2016-02-22
2018-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
Control
Treatment as usual with only assessment
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
44 Years
FEMALE
Yes
Sponsors
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Sonoma County Department of Health Services
UNKNOWN
La Clínica de La Raza Inc.
OTHER
Public Health Institute, California
OTHER
Responsible Party
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Principal Investigators
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Madhabika Nayak, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Public Health Institute
Locations
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La Clinica Women Infants and Children Program Site
Oakland, California, United States
Sonoma County Department of Health Services
Santa Rosa, California, United States
Countries
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References
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Nayak MB, Kaskutas LA, Mericle AA. Randomized Trial of an Innovative Electronic Screening and Brief Intervention for Reducing Drinking Among Women of Childbearing Age. J Addict Med. 2019 Nov/Dec;13(6):450-459. doi: 10.1097/ADM.0000000000000518.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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