Clinical trial NCT02337361: Computerized Tool for Preventing Prenatal Drinking
Official title: Preparing a Computerized Tool for Preventing Prenatal Drinking for a Larger Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foetal Exposure During Pregnancy
Keywords: risky alcohol use
pregnancy
Lead sponsor: Public Health Institute, California
Sponsor class: OTHER
Collaborators: name: Sonoma County Department of Health Services
name: La Clínica de La Raza Inc.
First posted: 2015-01-13
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Number of Participants Reporting Risky Alcohol Use
timeFrame: baseline, 3 months, 6 months
measure: Number of Participants Reporting Weekly Alcohol Use
timeFrame: baseline, 3 month, 6 month
measure: Number of Participants Reporting Heavy Alcohol Use
timeFrame: baseline, 3 month, 6 month
Secondary outcomes:
measure: Number of Participants Reporting Any Tobacco Use
timeFrame: baseline , 3 months, 6 months
measure: Number of Participants Reporting Frequent Sugar Sweetened Beverage Use
timeFrame: baseline, 3 months, 6 months
measure: Number of Participants Reporting Significant Depression
timeFrame: baseline, 3 months, 6 months
measure: Number of Participants Reporting Any Drug Use
timeFrame: baseline, 3 month, 6 month
Other outcomes:
Locations:
city: Oakland
country: United States
facility: La Clinica Women Infants and Children Program Site
state: California
city: Santa Rosa
country: United States
facility: Sonoma County Department of Health Services
state: California
Study officials:
affiliation: Public Health Institute
name: Madhabika Nayak, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.