Phase 1 N=48 Randomized Double-blind Screening

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

Alcohol Abuse

Bottom Line

View on ClinicalTrials.gov: NCT01643044 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Alcohol Use — 18; 14 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Nutrition time control/placebo intervention (Behavioral); Computer-delivered, brief intervention on alcohol use (Behavioral)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Wayne State University
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Alcohol Use	18; 14	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01643044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.