Foetal Exposure During Pregnancy Clinical Trial
Official title:
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02842645 -
Growth-Health and Development in Children Exposed to Drugs During Pregnancy
|
N/A |