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 |
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.
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.
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
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