Computerized Tool for Preventing Prenatal Drinking

Foetal Exposure During Pregnancy Clinical Trial

Official title:

Preparing a Computerized Tool for Preventing Prenatal Drinking for a Larger Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337361
• Other study ID #: R34AA022697
• Status: Completed
• Phase: N/A
• Start date: February 22, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: January 2019
• Source: Public Health Institute, California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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,

Related Conditions & MeSH terms

• Foetal Exposure During Pregnancy

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	La Clinica Women Infants and Children Program Site	Oakland	California
United States	Sonoma County Department of Health Services	Santa Rosa	California

Sponsors (3)

Lead Sponsor	Collaborator
Public Health Institute, California	La Clínica de La Raza Inc., Sonoma County Department of Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	baseline, 3 months, 6 months
Primary	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
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	baseline, 3 month, 6 month
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	baseline , 3 months, 6 months
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	baseline, 3 months, 6 months
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.	baseline, 3 months, 6 months
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	baseline, 3 month, 6 month