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

Wayne State University

Status and phase: Completed; Phase 1

Conditions: Alcohol Abuse

Treatments: Behavioral: Nutrition time control/placebo intervention; Behavioral: Computer-delivered, brief intervention on alcohol use

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01643044

R34AA020056 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Alcohol intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Computer-delivered, brief intervention on alcohol use

Control

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Nutrition time control/placebo intervention