Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to lay the ground work for a fully powered clinical trial of a computer-delivered screener and intervention for alcohol use during pregnancy. The pilot study will include:

1. Evaluation of the usefulness of handheld devices and anonymous screening for self report of at-risk alcohol use among pregnant women.
2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the detection of at-risk drinking in pregnant women.
3. Evaluation of the efficacy of a computer-delivered brief intervention and use of tailored handouts to supplement the computer-based brief intervention focusing on alcohol use during pregnancy.

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Detailed Description

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Infants born to African-American and/or low SES women appear to be at increased risk of adverse effects due to prenatal exposure to alcohol. Computer-delivered SBIRT approaches may provide consistent screening and evidence-based brief interventions, at low cost, without requiring substantial investments of time or energy from medical staff. However, several Stage I steps are necessary before moving to a Stage II clinical trial. This R34 application will therefore lay the groundwork for a fully powered clinical trial of a computer-delivered SBIRT for alcohol use during pregnancy. It will do so through the conduct of five key preliminary studies, including: (1) evaluation of the utility of handheld mobile devices and an anonymous self-interview format in screening for at-risk drinking among patients attending a prenatal clinic; (2) modification of an existing computer-delivered motivational intervention for alcohol use during pregnancy, to previously set standards of acceptability (to experts as well as representative pregnant women); (3) development of an evidence-based tailored messaging supplement to the single-session brief intervention; (4) examining the validity of, and cut scores for, the biomarker Ethyl Glucoronide (EtG) in pregnant women; and (5) collecting data on the acceptability, feasibility, and estimated effect size of the modified computer-delivered intervention through an N = 50 Phase I randomized clinical trial. Participants in this trial will be a diverse sample of women at-risk for alcohol use during pregnancy, the majority of whom will be African-American and/or low SES. These key preparatory steps will greatly facilitate the subsequent development of an R01 application to conduct a Stage II clinical trial for alcohol use during pregnancy. These steps will also provide important preliminary data on (a) a novel method for risk factor screening in primary care; (b) the potential utility of EtG as a biomarker for alcohol use during pregnancy and in the perinatal period; and (c) the effect size estimate for a fully computer-delivered, combined brief interactive/tailored messaging intervention requiring only a single contact. If successful, this line of research could lead to a highly cost-effective, high-reach intervention for alcohol use during pregnancy; these reductions in alcohol use could in turn have a meaningful population impact on Fetal Alcohol Spectrum Disorders.

Conditions

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Alcohol Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Alcohol intervention

Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.

Group Type EXPERIMENTAL

Computer-delivered, brief intervention on alcohol use

Intervention Type BEHAVIORAL

A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant.

Control

Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.

Group Type PLACEBO_COMPARATOR

Nutrition time control/placebo intervention

Intervention Type BEHAVIORAL

This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos.

Interventions

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Nutrition time control/placebo intervention

This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos.

Intervention Type BEHAVIORAL

Computer-delivered, brief intervention on alcohol use

A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* intention to carry pregnancy to term
* self-reported alcohol use
* willingness to be sent tailored messages
* gives consent to access medical records for collection of birth outcome data