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



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 40
Updated:5/5/2014
Start Date:April 2011
End Date:March 2014
Contact:Jessica R Beatty, Ph.D.
Email:jbeatty@wayne.edu
Phone:313-664-2518

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Computer-delivered SBIRT for Alcohol Use in Pregnancy: Planning a Stage II Trial

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.

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.

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

Exclusion Criteria:

- unable to communicate in English

- less than 4 months before delivery due date
We found this trial at
1
site
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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