Computerized Tool for Preventing Prenatal Drinking

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

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.

Study Overview

• Status: Completed
• Conditions: Foetal Exposure During Pregnancy
• Intervention / Treatment: Behavioral: Electronic SBI

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.

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94601
      • La Clinica Women Infants and Children Program Site
    • Santa Rosa, California, United States, 95403
      • Sonoma County Department of Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: e-SBI; Single session, Electronic SBI for risky alcohol use	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.
No Intervention: Control; Treatment as usual with only assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Public Health Institute, California
• Collaborators: La Clínica de La Raza Inc.; Sonoma County Department of Health Services
• Investigators: Principal Investigator: Madhabika Nayak, Ph.D., Public Health Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2016
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: pregnancy; risky alcohol use
• Other Study ID Numbers: R34AA022697 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO