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| Name | Class |
|---|---|
| Sonoma County Department of Health Services | UNKNOWN |
| La ClÃnica de La Raza Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| e-SBI | Experimental | Single session, Electronic SBI for risky alcohol use |
|
| Control | No Intervention | Treatment as usual with only assessment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic SBI | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 3 months, 6 months |
| Number of Participants Reporting Weekly Alcohol Use | weekly alcohol use is defined as at least drinking once a week or more often | baseline, 3 month, 6 month |
| 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 | baseline, 3 month, 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline , 3 months, 6 months |
| Number of Participants Reporting Frequent Sugar Sweetened Beverage Use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhabika Nayak, Ph.D. | Public Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Clinica Women Infants and Children Program Site | Oakland | California | 94601 | United States | ||
| Sonoma County Department of Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30882553 | Derived | 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. |
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Participant was assigned to control group but did not complete baseline assessment
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control | Treatment as usual with only assessment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Assessment |
| |||||||||||||
| 3-month Follow-up |
| |||||||||||||
| 6-month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 3 and 6 month numbers for each arm (study condition) reflect participant attrition over time | Posted | Count of Participants | Participants | baseline, 3 months, 6 months |
|
18 months, 6 months per participation, overall time frame includes screening for eligibility until the completion of the last (6-month follow-up) for the participants enrolled into the study last
The trial did not involve drugs or biologics, devices, or invasive procedures and involved a behavioral intervention with no known risks to participants.
Drinking and mental health behaviors included in outcomes were assessed at each follow up. But no adverse events were observed any time in the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Participants in the e-SBI group were re-administered the brief intervention at 3-month follow-up if they reported any alcohol use at that follow-up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madhabika B. Nayak | Public Health Institute/Alcohol Research Group | 510-898-5849 | mnayak@arg.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 15, 2015 | Dec 17, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 15, 2015 | Dec 17, 2018 | Prot_001.pdf |
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Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages |
| baseline, 3 months, 6 months |
| 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. | baseline, 3 months, 6 months |
| 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 | baseline, 3 month, 6 month |
| Santa Rosa |
| California |
| 95403 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Control | Treatment as usual with only assessment |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. to be enrolled in the trials as risky drinkers, participants had to meet these criteria for risky alcohol use. | Count of Participants | Participants |
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| OG001 | Control | Treatment as usual with only assessment |
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| Primary | Number of Participants Reporting Weekly Alcohol Use | weekly alcohol use is defined as at least drinking once a week or more often | 3 and 6 month numbers for each arm (study condition) reflect participant attrition over time | Posted | Count of Participants | Participants | baseline, 3 month, 6 month |
|
|
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| 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 | Numbers at 3 and 6 month reflect participant attrition | Posted | Count of Participants | Participants | baseline, 3 month, 6 month |
|
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| 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 | numbers at follow up reflect participant attrition over time | Posted | Count of Participants | Participants | baseline , 3 months, 6 months |
|
|
|
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| 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 | numbers at 3 and 6 month reflect participant attrition over time | Posted | Count of Participants | Participants | baseline, 3 months, 6 months |
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| 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. | numbers at 3 and 6 month reflect participant attrition over time | Posted | Count of Participants | Participants | baseline, 3 months, 6 months |
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| 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 | numbers at 3 and 6 month reflect participant attrition over time | Posted | Count of Participants | Participants | baseline, 3 month, 6 month |
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| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Control | Treatment as usual with only assessment | 0 | 86 | 0 | 86 | 0 | 86 |
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